According to a recent BBC Newsnight investigation, literally hundreds upon thousands of patients across the globe may have been exposed to potentially toxic substances following the implantation of metal-on-metal hip implants. Even though it is now believed that the dangers of these hip devices—which appear to have been very poorly regulated at best—was well known and documented for decades, recipients of the devices were nonetheless kept in the dark. The implants which are in question are known as “metal-on-metal,” and are constructed via a head at the top and a lining the head fits into which are made of cobalt-chromium alloy.
The Failure Rate of Metal-on-Metal Hip Implants
These hip implants are used in hip replacements and hip resurfacing, and came into wide-spread use in the 1997. The target group for these metal-on-metal hip replacements was younger, still-active patients who expected the hip replacement to last the rest of their life. Unfortunately, the numbers show that the failure rates among both genders are significantly higher than normal—from 11.8% failure in resurfacing to 13.6% for the total hip replacement as compared to rates of only between 3 and 5% for implants made of other materials.
How Many People Have Hip Implants?
Since 2003, the BBC article reports that over 60,000 patients in England and Wales and over a million in the United States have received the potentially dangerous metal-on-metal hip replacement. The metal ions from the cobalt and chromium hip implants are believed to seep into local tissues causing reactions which can not only destroy muscle and bone but can eventually leave the victim with a permanent disability. The fact that cobalt and chromium can lead to such serious health issues was actually documented in scientific journals over three decades ago.
Was There a Cover-up?
DePuy, a major manufacturer of the metal-on-metal hip implant, released an internal memo in 2005 which stated that in addition to possible changes in immune functioning there was additional concern that the metal debris from the device could be carcinogenic. The memo went on to state that the possibility of distant effects of the device was “worrying,” and that one study indicated a three times higher risk of lymphoma and leukemia ten years following the hip replacement. Despite these very real concerns DePuy continued marketing the device and indicated none of the potential health concerns in their subsequent promotional materials.
A Discussion of the Long-Term Health Effects of the Hip Implant
In 2006 the Medicines and Healthcare Products Regulatory Agency convened a meeting to discuss the long-term health effects of the metal-on-metal hip implant made from cobalt and chromium. An advisory board was appointed, however out of the group’s eight members, two were consultants for DePuy and one was the director of product development for Smith and Nephew—obvious conflicts of interest. In the end the group chose to sidestep the potential dangers of the metal-on-metal hip implants, even refusing to warn women of child-bearing age of the potential dangers despite the fact that metal ions had previously been detected in umbilical cord and placental blood among women with the implant. No alert was put out to either surgeons or patients, and it was not until March of 2011 that the British Orthopedic Association sent out a warning advising that the metal-on-metal hip replacements should be “carefully considered and possibly avoided.”
Excessive Levels of Cobalt Resulting from the Hip Implant
Although there are no current guidelines regarding unacceptable levels of cobalt ions in those receiving implants, a designer and consultant for DePuy theorizes that patients whose device is functioning properly should have cobalt levels of no more than 2 ug/L. Subsequent studies, however, have shown that the cobalt concentrations in the blood of those with a metal-on-metal hip implant have reached over 300 ug/L—approximately 600 times the levels in a person without a cobalt hip replacement device.
Design Changes to the Hip Implant
The BBC reports that the Pinnacle hip replacement device is not the only metal-on-metal implant with potential health hazards in the form of metal ion concentrations. Other implants made by Zimmer, DePuy, and Smith and Nephew have also showed an increase in metal ions in the body. Rather than alerting patients at any time in the past couple of decades regarding the potential hazards of the metal-on-metal implant, the companies “tweaked” the design of their hip implants by shortening the taper which inserts into the head and added grooves to allow surgeons the choice to use them with ceramic or metal heads. Unfortunately, these particular changes, when combined with bigger heads created another issue in the form of increased wear. This increased wear in turn led to higher levels of metal ions in the blood and greater joint failure rates.
The FDA Approval Process
Another internal e-mail among DePuy executives in 2009 discussed concerns by Japanese surgeons who reported observing “generated metal debris between stem taper and head, and final necrosed tissue.” Over five years after the design changes took place DePuy engineers were still struggling to determine why the implants were failing, yet patients had still not been warned of the potential dangers and surgeons were still implanting the devices. The 510(k) FDA approval process in the United States allows many potentially harmful devices to slip through the cracks when they are deemed to be “substantially equivalent,” to a device already on the market. When approved through the 510(k) process, no clinical trials are required. In May of 2011 the FDA invoked a rule which required post-marketing studies in which blood samples would be taken from those implanted with the metal-on-metal hip device to measure the metal ions. The FDA has also prohibited hip implants from being fast-tracked, placing them in a higher risk category.
As stated in the BMJ/BBC Newsnight investigation article by Deborah Cohen, not only have the manufacturers of the hip replacement devices demonstrated a completely inadequate response to the very real potential health hazards, the regulatory bodies have also failed to give doctors and patients the required information to allow them to make a valid decision about their health and their future. If you or a loved one has suffered ill effects from a metal-on-metal hip implant device you should seek legal representation as soon as possible to protect your future rights.
Product Defects, Accident and Injury law, Criminal Defense, Traffic Tickets, Family Law at Sullo & Sullo, LLP!
Showing posts with label johnson and johnson recall. Show all posts
Showing posts with label johnson and johnson recall. Show all posts
Transvaginal Mesh Discussions Part 1: Medical Conditions Which Precipitate the Use of Transvaginal Mesh
Pelvic Organ Prolapse (POP):
Pelvic organ prolapse happens when an organ in the pelvic area drops or prolapses from its normal position and pushes against the walls of the vagina or other organs. Especially in cases where the muscles which hold the pelvic organs in place become weak or stretched from childbirth or surgery, pelvic organ prolapse can occur. The vagina and uterus are held in place by ligaments, however when the pelvic floor muscles grow weaker the ligaments relax, allowing the vagina to move toward the vaginal opening.
The bladder and rectum are in close proximity to the vagina, so a prolapse can lead to a loss of bladder or bowel control, difficulty urinating or very frequent urination, a feeling in the vaginal region as though something has dropped, chronic bladder infections, moderate to severe pain during sexual intercourse and chronic pain in the back area. As many as one-third of all women in the United States will undergo some type of treatment for pelvic organ prolapse by the age of sixty, and by the age of eighty at least one out of ten women will have undergone surgery for the prolapse. Pelvic organ prolapse can severely limit a woman’s daily life, yet many women are embarrassed to speak to their doctors about their symptoms.
What Leads to POP?
Age is the primary factor in pelvic organ prolapse; menopause brings about loss of estrogen which in turn leads to loss of muscle tone. Women who have undergone multiple vaginal deliveries or who have a family history of pelvic organ prolapse are more likely to develop the condition as are those who have suffered some sort of pelvic trauma or prior pelvic surgery. Childbirth in particular causes the muscles, fascia and ligaments to separate and weaken as the baby passes through the birth canal and in later years may result in a drop of the pelvic organs from their normal position. Repeated heavy lifting can lead to pelvic organ prolapse as can being significantly overweight.
Women who have undergone a hysterectomy to remove their uterus may be at a higher risk as the other organs subsequently have less support and may prolapse. Women who have suffered extended periods of recurrent constipation or chronic coughing can be more likely to develop pelvic organ prolapse and medical conditions such as diabetes can also be a factor. Small or moderate amounts of urine can be lost in cases of pelvic organ prolapse even with normal physical activities such as walking, laughing or coughing. In short, many women will develop some level of pelvic organ prolapse which can range from the mildly uncomfortable to the severely painful. In some cases the pelvic organ prolapse will actually get better on its own with time, although this is not the norm.
Pelvic organ prolapse happens when an organ in the pelvic area drops or prolapses from its normal position and pushes against the walls of the vagina or other organs. Especially in cases where the muscles which hold the pelvic organs in place become weak or stretched from childbirth or surgery, pelvic organ prolapse can occur. The vagina and uterus are held in place by ligaments, however when the pelvic floor muscles grow weaker the ligaments relax, allowing the vagina to move toward the vaginal opening.
The bladder and rectum are in close proximity to the vagina, so a prolapse can lead to a loss of bladder or bowel control, difficulty urinating or very frequent urination, a feeling in the vaginal region as though something has dropped, chronic bladder infections, moderate to severe pain during sexual intercourse and chronic pain in the back area. As many as one-third of all women in the United States will undergo some type of treatment for pelvic organ prolapse by the age of sixty, and by the age of eighty at least one out of ten women will have undergone surgery for the prolapse. Pelvic organ prolapse can severely limit a woman’s daily life, yet many women are embarrassed to speak to their doctors about their symptoms.
What Leads to POP?
Age is the primary factor in pelvic organ prolapse; menopause brings about loss of estrogen which in turn leads to loss of muscle tone. Women who have undergone multiple vaginal deliveries or who have a family history of pelvic organ prolapse are more likely to develop the condition as are those who have suffered some sort of pelvic trauma or prior pelvic surgery. Childbirth in particular causes the muscles, fascia and ligaments to separate and weaken as the baby passes through the birth canal and in later years may result in a drop of the pelvic organs from their normal position. Repeated heavy lifting can lead to pelvic organ prolapse as can being significantly overweight.
Women who have undergone a hysterectomy to remove their uterus may be at a higher risk as the other organs subsequently have less support and may prolapse. Women who have suffered extended periods of recurrent constipation or chronic coughing can be more likely to develop pelvic organ prolapse and medical conditions such as diabetes can also be a factor. Small or moderate amounts of urine can be lost in cases of pelvic organ prolapse even with normal physical activities such as walking, laughing or coughing. In short, many women will develop some level of pelvic organ prolapse which can range from the mildly uncomfortable to the severely painful. In some cases the pelvic organ prolapse will actually get better on its own with time, although this is not the norm.
Transvaginal Mesh Discussions Part 3: Problems and Warnings
Problems Caused by Transvaginal Mesh Implants
Once the mesh is implanted in the body, it can move around leading to potentially serious injuries in the form of nearby organ punctures or frayed edges of the mesh eating into surrounding tissues. Some women have become septic as a result of the mesh implant, such severe infections, when not treated immediately, can lead to death in some cases. Other common complaints regarding the transvaginal mesh implants include extremely painful intercourse, scarring in the areas surrounding the mesh implant, a recurrence of the original pelvic organ prolapse, and chronic urinary infections and problems.
It is estimated that erosion of the transvaginal mesh implant into surrounding organs and tissues occurs in about 10 percent of all women who have undergone vaginal prolapsed repairs using mesh. In some cases the mesh material can be removed during another surgical procedure, however in some cases tissue may have grown in and around the mesh leading to multiple surgeries or interventions. Many women are not fully informed about alternatives to mesh implants, nor are they informed about the possible risks of transvaginal mesh implants.
Has There Been a Recall of Transvaginal Mesh Implants?
There are currently many, many manufacturers of transvaginal mesh, however the majority of the negative reports regarding the mesh center around the following mesh brand-names along with the manufacturer. Gynecare, Gynemesh and Ethico are Johnson and Johnson products, Avaulta, Pelvicol and Pelvisoft are manufactured by C.R. Bard, The Advantage Sling, Obtryx, Perfyx and Pinnacle are made by Boston Scientific, and Spar, Miniarc, Monarc, Apogee, Perigee and Elevate are made by American Medical Systems. It appears that the use of surgical mesh to treat pelvic organ prolapse or SUI may never have been sufficiently tested; after gynecologists began using mesh in their surgical applications in the 90’s the FDA approved the mesh under a 510(k) clearance “loophole,” meaning the mesh was approved without proper testing and clinical trials.
The pelvic transvaginal mesh types currently bringing so much concern are very similar to the ProtoGen mesh which was recalled over a decade ago. In October of 2008 a Public Health Notification was issued by the FDA cautioning physicians about potential health issues resulting from the implantation of transvaginal mesh. At this point the FDA had received hundreds of reports of negative health issues from use of the transvaginal mesh implant. It was not until July of 2011, however, that the FDA issued an updated safety warning which indicated serious complications could arise from the use of transvaginal mesh implants, and that those complications were “not rare.”
The FDA further stated that repairs done with transvaginal mesh rather than the more traditional surgery which did not use mesh had not been shown to significantly improve the results of the surgery or the quality of life in the patient. FDA studies show that over ten percent of all women who undergo transvaginal pelvic organ prolapse repair will experience erosion of the mesh into surrounding tissues or organs within the twelve-month period following surgery. This statistic is considered significant among such surgical implants. The FDA revealed in January of this year that they are considering a recommendation that mesh used in the repair of prolapse of pelvic organs undergo a reclassification from a Class 2 to a Class 3 which would cause manufacturer’s safety requirements to be much stricter.
The FDA also ordered the manufacturers of the transvaginal mesh to conduct new trials and studies to more fully assess mesh safety and the risk of complications. While some consumer organizations have demanded the FDA recall the mesh implants and ban any further promotion of transvaginal mesh, other well-recognized medical organizations have yet to reach a definitive conclusion about discontinuing the use of the mesh implants. While the FDA acknowledges the dangers of the mesh they have not issues a recall and it is highly doubtful that the manufacturers of the transvaginal mesh will issue a voluntary recall. The current FDA warning applies only to transvaginally placed mesh and does not include abdominally-placed mesh or mesh used to correct stress urinary incontinence.
Once the mesh is implanted in the body, it can move around leading to potentially serious injuries in the form of nearby organ punctures or frayed edges of the mesh eating into surrounding tissues. Some women have become septic as a result of the mesh implant, such severe infections, when not treated immediately, can lead to death in some cases. Other common complaints regarding the transvaginal mesh implants include extremely painful intercourse, scarring in the areas surrounding the mesh implant, a recurrence of the original pelvic organ prolapse, and chronic urinary infections and problems.
It is estimated that erosion of the transvaginal mesh implant into surrounding organs and tissues occurs in about 10 percent of all women who have undergone vaginal prolapsed repairs using mesh. In some cases the mesh material can be removed during another surgical procedure, however in some cases tissue may have grown in and around the mesh leading to multiple surgeries or interventions. Many women are not fully informed about alternatives to mesh implants, nor are they informed about the possible risks of transvaginal mesh implants.
Has There Been a Recall of Transvaginal Mesh Implants?
There are currently many, many manufacturers of transvaginal mesh, however the majority of the negative reports regarding the mesh center around the following mesh brand-names along with the manufacturer. Gynecare, Gynemesh and Ethico are Johnson and Johnson products, Avaulta, Pelvicol and Pelvisoft are manufactured by C.R. Bard, The Advantage Sling, Obtryx, Perfyx and Pinnacle are made by Boston Scientific, and Spar, Miniarc, Monarc, Apogee, Perigee and Elevate are made by American Medical Systems. It appears that the use of surgical mesh to treat pelvic organ prolapse or SUI may never have been sufficiently tested; after gynecologists began using mesh in their surgical applications in the 90’s the FDA approved the mesh under a 510(k) clearance “loophole,” meaning the mesh was approved without proper testing and clinical trials.
The pelvic transvaginal mesh types currently bringing so much concern are very similar to the ProtoGen mesh which was recalled over a decade ago. In October of 2008 a Public Health Notification was issued by the FDA cautioning physicians about potential health issues resulting from the implantation of transvaginal mesh. At this point the FDA had received hundreds of reports of negative health issues from use of the transvaginal mesh implant. It was not until July of 2011, however, that the FDA issued an updated safety warning which indicated serious complications could arise from the use of transvaginal mesh implants, and that those complications were “not rare.”
The FDA further stated that repairs done with transvaginal mesh rather than the more traditional surgery which did not use mesh had not been shown to significantly improve the results of the surgery or the quality of life in the patient. FDA studies show that over ten percent of all women who undergo transvaginal pelvic organ prolapse repair will experience erosion of the mesh into surrounding tissues or organs within the twelve-month period following surgery. This statistic is considered significant among such surgical implants. The FDA revealed in January of this year that they are considering a recommendation that mesh used in the repair of prolapse of pelvic organs undergo a reclassification from a Class 2 to a Class 3 which would cause manufacturer’s safety requirements to be much stricter.
The FDA also ordered the manufacturers of the transvaginal mesh to conduct new trials and studies to more fully assess mesh safety and the risk of complications. While some consumer organizations have demanded the FDA recall the mesh implants and ban any further promotion of transvaginal mesh, other well-recognized medical organizations have yet to reach a definitive conclusion about discontinuing the use of the mesh implants. While the FDA acknowledges the dangers of the mesh they have not issues a recall and it is highly doubtful that the manufacturers of the transvaginal mesh will issue a voluntary recall. The current FDA warning applies only to transvaginally placed mesh and does not include abdominally-placed mesh or mesh used to correct stress urinary incontinence.
Transvaginal Mesh Complications and Corrective Procedures: The Long Road to Recovery
In the past few years more and more women are coming forward to report complications—some of them quite severe—which resulted from surgeries involving the use of transvaginal mesh implants. Mesh has been implemented in surgeries as far back as the 1950’s, when it was used in hernia repair over the more traditional suture repair, with excellent results. In fact, when the mesh procedure was used there was a significantly lower recurrence of the hernias.
Doctors soon began using the mesh in other applications such as the repair of pelvic organ prolapse and stress incontinence, simply cutting it to the size needed. Unfortunately, due perhaps to the difference in elasticity between the abdominal area and pelvic area, many women have reported medical issues following their mesh surgery including severe infections, pain in the pelvic region, adhesions, mesh erosion, chronic urinary tract infections, bowel and bladder injuries, painful scarring, painful sexual intercourse, and even death in a few tragic cases. Correcting these injuries can require one or more surgeries performed by a surgeon with training and experience in mesh injury surgeries.
Mesh Extrusion or Erosion
The most common complication of the transvaginal mesh placement occurs when the mesh breaks through the incision or the vaginal lining, resulting in bleeding, excess vaginal discharge, recurring urinary tract infections, drainage of urine into the vagina and can even cause pain to a male partner during intercourse. The exposed mesh as well as the surrounding injured vaginal tissue must be removed followed by pelvic reconstructive surgery. Some of the most highly skilled surgeons in the country are implementing a new surgical instrument known as the Plasma Blade in favor of the more traditional scalpel or cauterization devices, however it can be difficult to find a surgeon trained in using this innovative instrument.
If the mesh has eroded into the bladder, it must first be removed, then the damage to the bladder and the vaginal wall must be repaired, usually through the abdomen with a fairly large incision and a relatively long recovery time. Depending on the extent of the erosion some doctors perform the procedure laparoscopically, which is typically an outpatient surgery done through a mini-incision in the belly button. Performing the repairs in this manner is considered an advanced procedure and should only be attempted by a surgeon who is highly experienced in the technique as well as the necessary pelvic reconstruction. Should the mesh have eroded into the bowel or rectum it is considered a very serious complication.
Chronic Pain
Pain which results from the transvaginal mesh implant can be very difficult to treat, and is typically a result of the placement of the mesh rather than the specific material of the mesh. If the mesh implant is too small or requires attachment near the pudendal nerve, then there may be moderate to severe pain for the first two months following the surgery and in some cases for much longer. If the pain persists longer than two months or if it radiates down the leg then surgical intervention will likely be required to alleviate the pain. Back pain and lower abdominal pain are named by the FDA as complications of the transvaginal mesh implant. If the pain is related to tension, or the mesh being too tight and pulling on the surrounding ligaments and muscles, the surgeon may have to open up the original incision, cutting the higher attachment points of the mesh implant. If tension is not the cause of the pain, treatment can be more difficult and could include injections or surgical release of the pudendal nerve—a highly skilled surgery which is currently performed by only a few surgeons across the nation.
Different Types of Mesh
Studies show that a Type I mesh tends to be tolerated better, resulting in the fewest complications when used in POP and SUI surgeries, and infections using this type of mesh are rare. Type I meshes are monofilament and somewhat porous, which allows the body’s bacteria-fighting cells to have unimpeded access to the mesh implant. Mesh made of Gore-tex has been shown to cause the highest rates of infection and erosion therefore is being used less and less often in the transvaginal application.
Women Suffering from Mesh Complications
Prior to the FDA issuance of warnings regarding the potential complications of the mesh implant, many women suffered in silence, too embarrassed to speak out. Over 4,000 women have come forward—with many more expected—to speak out about the serious symptoms they have suffered as a result of their transvaginal mesh implant. Some women have undergone multiple surgeries in an attempt to prevent further pain and suffering. Not only have these women had to have the mesh from their original surgeries removed, but have then required further corrective surgeries to repair the damage done by the mesh. If you or a loved one has suffered harm from the mesh implant it’s important that you first speak with an experienced and reputable physician then find a highly qualified attorney to discuss your potential case with.
Doctors soon began using the mesh in other applications such as the repair of pelvic organ prolapse and stress incontinence, simply cutting it to the size needed. Unfortunately, due perhaps to the difference in elasticity between the abdominal area and pelvic area, many women have reported medical issues following their mesh surgery including severe infections, pain in the pelvic region, adhesions, mesh erosion, chronic urinary tract infections, bowel and bladder injuries, painful scarring, painful sexual intercourse, and even death in a few tragic cases. Correcting these injuries can require one or more surgeries performed by a surgeon with training and experience in mesh injury surgeries.
Mesh Extrusion or Erosion
The most common complication of the transvaginal mesh placement occurs when the mesh breaks through the incision or the vaginal lining, resulting in bleeding, excess vaginal discharge, recurring urinary tract infections, drainage of urine into the vagina and can even cause pain to a male partner during intercourse. The exposed mesh as well as the surrounding injured vaginal tissue must be removed followed by pelvic reconstructive surgery. Some of the most highly skilled surgeons in the country are implementing a new surgical instrument known as the Plasma Blade in favor of the more traditional scalpel or cauterization devices, however it can be difficult to find a surgeon trained in using this innovative instrument.
If the mesh has eroded into the bladder, it must first be removed, then the damage to the bladder and the vaginal wall must be repaired, usually through the abdomen with a fairly large incision and a relatively long recovery time. Depending on the extent of the erosion some doctors perform the procedure laparoscopically, which is typically an outpatient surgery done through a mini-incision in the belly button. Performing the repairs in this manner is considered an advanced procedure and should only be attempted by a surgeon who is highly experienced in the technique as well as the necessary pelvic reconstruction. Should the mesh have eroded into the bowel or rectum it is considered a very serious complication.
Chronic Pain
Pain which results from the transvaginal mesh implant can be very difficult to treat, and is typically a result of the placement of the mesh rather than the specific material of the mesh. If the mesh implant is too small or requires attachment near the pudendal nerve, then there may be moderate to severe pain for the first two months following the surgery and in some cases for much longer. If the pain persists longer than two months or if it radiates down the leg then surgical intervention will likely be required to alleviate the pain. Back pain and lower abdominal pain are named by the FDA as complications of the transvaginal mesh implant. If the pain is related to tension, or the mesh being too tight and pulling on the surrounding ligaments and muscles, the surgeon may have to open up the original incision, cutting the higher attachment points of the mesh implant. If tension is not the cause of the pain, treatment can be more difficult and could include injections or surgical release of the pudendal nerve—a highly skilled surgery which is currently performed by only a few surgeons across the nation.
Different Types of Mesh
Studies show that a Type I mesh tends to be tolerated better, resulting in the fewest complications when used in POP and SUI surgeries, and infections using this type of mesh are rare. Type I meshes are monofilament and somewhat porous, which allows the body’s bacteria-fighting cells to have unimpeded access to the mesh implant. Mesh made of Gore-tex has been shown to cause the highest rates of infection and erosion therefore is being used less and less often in the transvaginal application.
Women Suffering from Mesh Complications
Prior to the FDA issuance of warnings regarding the potential complications of the mesh implant, many women suffered in silence, too embarrassed to speak out. Over 4,000 women have come forward—with many more expected—to speak out about the serious symptoms they have suffered as a result of their transvaginal mesh implant. Some women have undergone multiple surgeries in an attempt to prevent further pain and suffering. Not only have these women had to have the mesh from their original surgeries removed, but have then required further corrective surgeries to repair the damage done by the mesh. If you or a loved one has suffered harm from the mesh implant it’s important that you first speak with an experienced and reputable physician then find a highly qualified attorney to discuss your potential case with.
Transvaginal Mesh: Is an FDA Recall on the Horizon?
Even though some consumer advocate groups—such as Public Citizen—have called for the FDA to ban the marketing of transvaginal mesh for use in surgeries such as the repair of pelvic organ prolapse and stress urinary incontinence as yet there has been no definitive conclusions reached as to whether the use of mesh should be permanently discontinued. The FDA has made physicians and the public aware of the potential risks involved in using transvaginal mesh including erosion, contraction or shrinkage of the mesh once it has been implanted, however now must decide whether further action is called for in light of the flurry of lawsuits regarding mesh complications.
It is highly unlikely that the manufacturers of the mesh will issue a voluntary recall, although the FDA may choose to elevate the approval process for the mesh from the moderate risk Class II to the higher-risk Class III. If the mesh device class is reclassified, manufacturers will face a much tougher process when gaining FDA approval and will also be required to conduct human trials. A Class III is the highest risk category for medical devices however the FDA could conceivably bump up the existing class level without recalling existing devices. Finally, the FDA could issue sterner warnings regarding the mesh devices to both physicians and patients while allowing the device to keep the same approval process, meaning that new mesh products which are substantially equivalent to already-approved ones would be granted approval.
FDA Safety Recommendations
Currently the FDA has issued safety recommendations and warnings regarding the use of transvaginal mesh implants including:
Patients who have pelvic organ prolapse surgery using mesh may be subject to complications which are not experienced by those undergoing more traditional forms of POP surgery without mesh.
Placement of the transvaginal mesh patch may be life-altering for some women, and the chronic levels of pain can sometimes continue even after the mesh is surgically removed.
Mesh-associated complications are not rare—approximately ten percent of women who undergo pelvic organ prolapse surgery with mesh experienced some level of erosion within the first year following the surgery.
Erosion is the most common complication, and of the women who experienced erosion of the mesh into the vaginal wall or other organs, more than half required surgical excision of the mesh with some requiring multiple surgeries.
Many women have reported mesh contraction which results in chronic vaginal pain or vaginal shortening.
When mesh is used in stress urinary incontinence surgeries recurrence of the SUI is more common than in traditional repair which doesn’t use mesh.
When mesh is used to perform a pelvic organ prolapse surgery abdominally, it appears to have lower rates of complications as compared to transvaginal surgery with mesh.
As far as effectiveness, the FDA states that transvaginal repair with mesh does not appear to provide any added benefits compared to more traditional surgeries without mesh.
The FDA goes on to state, however that so far the adverse events which resulted from transvaginal mesh surgeries were both inconsistently defined and reported, that very few of the existing studies extended longer than two years, and that the studies which exist tend to be poorly designed, poorly conducted and fail to account for variable patient follow-up length. The results from the few studies which exist reflect both primary and repeat prolapse repairs which could skewer the overall results.
FDA Recommendations for Women Considering POP Mesh Surgery
The FDA recommends that women who are considering pelvic organ prolapse surgery using mesh should be fully aware of the potential risks and complications of mesh implants. Women should also know that having a surgery using mesh could potentially increase the risk for additional surgeries should there be mesh-related complications, and in some patients additional surgeries fail to resolve the pain or other medical issues. Ask your doctor about alternatives to mesh surgery, and if you decide transvaginal mesh surgery is right for you, make sure your surgeon has extensive experience in performing the procedure.
If you’ve already undergone POP surgery using mesh, you must notify your healthcare provider if you have any complications or symptoms such as persistent pain, infection, or persistent bleeding. If you believe you have suffered harm from the use of a mesh device, it’s important that you seek knowledgeable counsel regarding your rights and your potential for filing a lawsuit against the manufacturer of the device.
It is highly unlikely that the manufacturers of the mesh will issue a voluntary recall, although the FDA may choose to elevate the approval process for the mesh from the moderate risk Class II to the higher-risk Class III. If the mesh device class is reclassified, manufacturers will face a much tougher process when gaining FDA approval and will also be required to conduct human trials. A Class III is the highest risk category for medical devices however the FDA could conceivably bump up the existing class level without recalling existing devices. Finally, the FDA could issue sterner warnings regarding the mesh devices to both physicians and patients while allowing the device to keep the same approval process, meaning that new mesh products which are substantially equivalent to already-approved ones would be granted approval.
FDA Safety Recommendations
Currently the FDA has issued safety recommendations and warnings regarding the use of transvaginal mesh implants including:
Patients who have pelvic organ prolapse surgery using mesh may be subject to complications which are not experienced by those undergoing more traditional forms of POP surgery without mesh.
Placement of the transvaginal mesh patch may be life-altering for some women, and the chronic levels of pain can sometimes continue even after the mesh is surgically removed.
Mesh-associated complications are not rare—approximately ten percent of women who undergo pelvic organ prolapse surgery with mesh experienced some level of erosion within the first year following the surgery.
Erosion is the most common complication, and of the women who experienced erosion of the mesh into the vaginal wall or other organs, more than half required surgical excision of the mesh with some requiring multiple surgeries.
Many women have reported mesh contraction which results in chronic vaginal pain or vaginal shortening.
When mesh is used in stress urinary incontinence surgeries recurrence of the SUI is more common than in traditional repair which doesn’t use mesh.
When mesh is used to perform a pelvic organ prolapse surgery abdominally, it appears to have lower rates of complications as compared to transvaginal surgery with mesh.
As far as effectiveness, the FDA states that transvaginal repair with mesh does not appear to provide any added benefits compared to more traditional surgeries without mesh.
The FDA goes on to state, however that so far the adverse events which resulted from transvaginal mesh surgeries were both inconsistently defined and reported, that very few of the existing studies extended longer than two years, and that the studies which exist tend to be poorly designed, poorly conducted and fail to account for variable patient follow-up length. The results from the few studies which exist reflect both primary and repeat prolapse repairs which could skewer the overall results.
FDA Recommendations for Women Considering POP Mesh Surgery
The FDA recommends that women who are considering pelvic organ prolapse surgery using mesh should be fully aware of the potential risks and complications of mesh implants. Women should also know that having a surgery using mesh could potentially increase the risk for additional surgeries should there be mesh-related complications, and in some patients additional surgeries fail to resolve the pain or other medical issues. Ask your doctor about alternatives to mesh surgery, and if you decide transvaginal mesh surgery is right for you, make sure your surgeon has extensive experience in performing the procedure.
If you’ve already undergone POP surgery using mesh, you must notify your healthcare provider if you have any complications or symptoms such as persistent pain, infection, or persistent bleeding. If you believe you have suffered harm from the use of a mesh device, it’s important that you seek knowledgeable counsel regarding your rights and your potential for filing a lawsuit against the manufacturer of the device.
Transvaginal Mesh Lawsuits: What You Need to Know
If you are a woman who has had a surgery in the past for stress urinary incontinence or pelvic organ prolapse, and you think your surgeon might have used a mesh implant during that surgery, you need to know the facts surrounding the mesh products. While highly similar mesh products have been used in surgical applications for decades—primarily in hernia surgeries—it was not until 1996 that mesh was approved for use in SUI surgeries and 2002 when the mesh was FDA approved for use in POP surgeries. Up until that time surgeons simply adapted the mesh used in hernia surgeries to suit other surgical applications.
Flaws in the Approval Process?
The mesh was able to be implanted into the vaginal wall without the necessity of prior controlled human studies through a sort of governmental loophole known as a 510(k) clearance approval. This type of less-stringent approval process allows a quicker approval without the necessity of clinical trials for medical devices which are substantially equivalent to already-approved devices. What was not anticipated, however, was the differences in pelvic region tissue as opposed to abdominal tissue. The fragile tissues in the pelvic region tend to be much more flexible, therefore the relatively inelastic mesh which works well in the abdomen tends to pull at the surrounding areas and erode through the more delicate tissues.
Mesh Manufacturers on the Hook?
The transvaginal mesh surgeries are performed on as many as 70,000 women each year, leaving these women vulnerable to potential complications. The manufacturers of the mesh implants are currently the target of over 4,000 lawsuits under the belief they sidestepped their legal duty to ensure the mesh products were properly designed, tested and manufactured. Although some consumer advocate groups are calling for a recall of all mesh products when used in implantation in the vaginal wall, the American Congress of Obstetricians and Gynecologists have yet to reach a final conclusion as to whether mesh use in this application should be entirely discontinued. The FDA, while recognizing the risks of vaginal mesh are presently considering several options with an ultimate goal of protecting women from harm. The Journal of Obstetrics & Gynecology published the results of a randomized controlled trial in August of 2010 regarding the use of mesh for pelvic organ prolapse. At three months, there was a 15.6% vaginal mesh erosion rate with “no difference in overall objective and subjective cure rates.”
What are the Complications of Transvaginal Mesh?
While there are other possible factors related to complications from transvaginal mesh implants—smoking, age, menopausal status, the presence of hormone replacement therapy, a woman’s body mass index and whether the woman suffers from diabetes—these factors have not definitively been shown to link directly to the mesh complications. The primary complication suffered by women who have undergone a transvaginal mesh implant is erosion of the mesh into the surrounding vaginal walls or other organs. This mesh erosion can lead to serious infection, bleeding, chronic and severe levels of pain in the back and abdomen, persistent urinary tract infections and pain during intercourse. If a physician determines the mesh has eroded it will be necessary for the patient to undergo one or more surgeries to correct the erosion. In some cases women have required multiple surgeries, and in other cases surgeons are unable to completely alleviate the pain.
More Women Coming Forward
It appears that over 4,000 women have come forward with adverse reports of damage from the transvaginal mesh implant. Because of the nature of the product, it is believed there are many more women who have suffered, but have not come forward because they are uncomfortable discussing problems and complications of this nature. The truth is, this is a problem which impacts literally millions of women. Half of all women who have had children will suffer some level of prolapse over the course of their lives. As many as ten percent of women will require surgery for pelvic organ prolapse, meaning a substantial portion of those were likely subject to the mesh implant. Many women believed their complications had subsided only to have them return, some even worse than they were originally. Women should not have to suffer in silence, and more women are coming forward to speak out against manufacturers who did not give women’s health and futures the proper consideration.
Do You Have a Case?
Lawyers around the nation are filing suits against the manufacturers of the mesh used in POP and SUI surgeries on behalf of women harmed by the device. Many of these women have already suffered subsequent surgeries to remove the mesh from the pelvic tissue and to further treat the complications from the mesh defects. Many more women will require more surgeries in order to regain some semblance of their former quality of life. The majority of the lawsuits which have already been filed are against C.R. Bard and Ethicon which is a Johnson and Johnson subsidiary. If you have had ongoing and severe symptoms of mesh erosion and are facing more surgeries to correct the problem, you likely have specific damages and should consult a reputable, experienced attorney to evaluate your case.
Flaws in the Approval Process?
The mesh was able to be implanted into the vaginal wall without the necessity of prior controlled human studies through a sort of governmental loophole known as a 510(k) clearance approval. This type of less-stringent approval process allows a quicker approval without the necessity of clinical trials for medical devices which are substantially equivalent to already-approved devices. What was not anticipated, however, was the differences in pelvic region tissue as opposed to abdominal tissue. The fragile tissues in the pelvic region tend to be much more flexible, therefore the relatively inelastic mesh which works well in the abdomen tends to pull at the surrounding areas and erode through the more delicate tissues.
Mesh Manufacturers on the Hook?
The transvaginal mesh surgeries are performed on as many as 70,000 women each year, leaving these women vulnerable to potential complications. The manufacturers of the mesh implants are currently the target of over 4,000 lawsuits under the belief they sidestepped their legal duty to ensure the mesh products were properly designed, tested and manufactured. Although some consumer advocate groups are calling for a recall of all mesh products when used in implantation in the vaginal wall, the American Congress of Obstetricians and Gynecologists have yet to reach a final conclusion as to whether mesh use in this application should be entirely discontinued. The FDA, while recognizing the risks of vaginal mesh are presently considering several options with an ultimate goal of protecting women from harm. The Journal of Obstetrics & Gynecology published the results of a randomized controlled trial in August of 2010 regarding the use of mesh for pelvic organ prolapse. At three months, there was a 15.6% vaginal mesh erosion rate with “no difference in overall objective and subjective cure rates.”
What are the Complications of Transvaginal Mesh?
While there are other possible factors related to complications from transvaginal mesh implants—smoking, age, menopausal status, the presence of hormone replacement therapy, a woman’s body mass index and whether the woman suffers from diabetes—these factors have not definitively been shown to link directly to the mesh complications. The primary complication suffered by women who have undergone a transvaginal mesh implant is erosion of the mesh into the surrounding vaginal walls or other organs. This mesh erosion can lead to serious infection, bleeding, chronic and severe levels of pain in the back and abdomen, persistent urinary tract infections and pain during intercourse. If a physician determines the mesh has eroded it will be necessary for the patient to undergo one or more surgeries to correct the erosion. In some cases women have required multiple surgeries, and in other cases surgeons are unable to completely alleviate the pain.
More Women Coming Forward
It appears that over 4,000 women have come forward with adverse reports of damage from the transvaginal mesh implant. Because of the nature of the product, it is believed there are many more women who have suffered, but have not come forward because they are uncomfortable discussing problems and complications of this nature. The truth is, this is a problem which impacts literally millions of women. Half of all women who have had children will suffer some level of prolapse over the course of their lives. As many as ten percent of women will require surgery for pelvic organ prolapse, meaning a substantial portion of those were likely subject to the mesh implant. Many women believed their complications had subsided only to have them return, some even worse than they were originally. Women should not have to suffer in silence, and more women are coming forward to speak out against manufacturers who did not give women’s health and futures the proper consideration.
Do You Have a Case?
Lawyers around the nation are filing suits against the manufacturers of the mesh used in POP and SUI surgeries on behalf of women harmed by the device. Many of these women have already suffered subsequent surgeries to remove the mesh from the pelvic tissue and to further treat the complications from the mesh defects. Many more women will require more surgeries in order to regain some semblance of their former quality of life. The majority of the lawsuits which have already been filed are against C.R. Bard and Ethicon which is a Johnson and Johnson subsidiary. If you have had ongoing and severe symptoms of mesh erosion and are facing more surgeries to correct the problem, you likely have specific damages and should consult a reputable, experienced attorney to evaluate your case.
Transvaginal Mesh: The Types of Surgeries Which Use this Controversial Device
As more information comes to light regarding the potential safety issues of the transvaginal mesh implants, women across the nation have more questions regarding the device. The FDA has yet to make a final determination on how mesh devices will be approved in the future and whether the current manufacturers will be subject to more rigorous scrutiny regarding the mesh device. It appears that there are now thousands of women coming forward with stories of adverse events following their transvaginal mesh surgery leading the FDA to require sterner warnings regarding use of the mesh. Physicians are being warned to strongly consider alternative or more traditional surgical methods in repairing pelvic organ prolapse and stress urinary incontinence and women are urged to be fully informed of potential risks before undergoing transvaginal mesh surgery.
Hernia Repair Using Mesh
The mesh used in many surgeries today was originally used strictly for abdominal hernia surgeries and appeared to work well in this application although there were some complications reported. The patch for a hernia repair is typically larger than one used in a transvaginal application so remains in place more securely. Studies show that a Type I mesh tends to be tolerated better, resulting in the fewest complications when used in hernia, POP and SUI surgeries, and infections using this type of mesh are rare. Type I meshes are monofilament and somewhat porous, which allows the body’s bacteria-fighting cells to have unimpeded access to the mesh implant. Mesh made of Gore-tex has been shown to cause the highest rates of infection and erosion therefore is being used less and less often in the transvaginal application.
Necessity for Pelvic Organ Prolapse Surgery
In a woman’s twenties and thirties her natural connective tissues and ligaments will hold her pelvic organs firmly in place. As women age and undergo pregnancy and childbirth, those connective tissues begin to stretch out of place, allowing the descent of one or more of the pelvic organs including the uterus, vagina, bladder or rectum. The fascia in a healthy pelvic floor is comprised of a natural elastic mesh layer which keeps the organs where they should be. When this fascia begins to break down and weaken, organ prolapse can occur in varying degrees of seriousness. It is estimated that as many as half of all women who have had at least one full term pregnancy have some level of pelvic organ prolapse.
Risk Factors for Pelvic Organ Prolapse
The known risk factors which increase the odds of pelvic organ prolapse consist of the ever-present genetic link, menopause, being older than sixty, previous pelvic surgery or surgeries, number of full-term pregnancies as well as issues associated with increased stomach pressure such as being overweight. Even though fifty percent of women who have gone through childbirth may have some level of POP, most of them do not have symptoms so severe as to require surgery.
For those women who do have symptoms severe enough to affect their overall quality of life, they may need to have some form of surgical treatment to alleviate the pain and other symptoms. It is necessary to fully evaluate each woman’s individual case before deciding on a course of action. The length and severity of the symptoms will of course be a factor as well as the woman’s desire for treatment the degree of the prolapse and whether or not she is healthy enough to undergo surgery.
Surgical Types and Issues
The goal of surgery is to provide the necessary support for your pelvic organs, and mesh is used in an attempt to reduce the risk of recurrence of the prolapse. Mesh typically offers a longer-lasting repair when all goes well and is successful in at least 80% of the POP surgeries it is used in. What the patient must remember is that mesh is a synthetic material and becomes a permanent part of the body.
The mesh has tiny holes which allow the body’s own tissue to grow into it, providing the necessary support framework. Women undergoing the surgery may have either general or regional anesthesia; incisions are made by the surgeon inside the vagina, and the surrounding tissues are strengthened with stitches. The mesh will be placed under the vaginal skin, and the tissues of the body will grow into the mesh within 3-4 weeks which provides the reinforcement needed for the weakened tissues.
Complications of Transvaginal Mesh Surgery
The complications of the mesh surgery result primarily from mesh erosion, meaning the mesh erodes into the vaginal walls or into other organs. This erosion can lead to severe—or in rare cases, even fatal—consequences, and typically requires another surgery to correct the erosion and remove the mesh patch. Women who have suffered mesh erosion from the transvaginal mesh surgery may experience repeated infections, chronic abdominal or back pain or urinary tract problems, and depending on the severity of the erosion could require multiple surgeries.
If the use of mesh has caused you to have severe complications, it is important that you first take care of your health then consult a reputable attorney who can evaluate the facts of your mesh surgery and determine whether you have a potential case.
Hernia Repair Using Mesh
The mesh used in many surgeries today was originally used strictly for abdominal hernia surgeries and appeared to work well in this application although there were some complications reported. The patch for a hernia repair is typically larger than one used in a transvaginal application so remains in place more securely. Studies show that a Type I mesh tends to be tolerated better, resulting in the fewest complications when used in hernia, POP and SUI surgeries, and infections using this type of mesh are rare. Type I meshes are monofilament and somewhat porous, which allows the body’s bacteria-fighting cells to have unimpeded access to the mesh implant. Mesh made of Gore-tex has been shown to cause the highest rates of infection and erosion therefore is being used less and less often in the transvaginal application.
Necessity for Pelvic Organ Prolapse Surgery
In a woman’s twenties and thirties her natural connective tissues and ligaments will hold her pelvic organs firmly in place. As women age and undergo pregnancy and childbirth, those connective tissues begin to stretch out of place, allowing the descent of one or more of the pelvic organs including the uterus, vagina, bladder or rectum. The fascia in a healthy pelvic floor is comprised of a natural elastic mesh layer which keeps the organs where they should be. When this fascia begins to break down and weaken, organ prolapse can occur in varying degrees of seriousness. It is estimated that as many as half of all women who have had at least one full term pregnancy have some level of pelvic organ prolapse.
Risk Factors for Pelvic Organ Prolapse
The known risk factors which increase the odds of pelvic organ prolapse consist of the ever-present genetic link, menopause, being older than sixty, previous pelvic surgery or surgeries, number of full-term pregnancies as well as issues associated with increased stomach pressure such as being overweight. Even though fifty percent of women who have gone through childbirth may have some level of POP, most of them do not have symptoms so severe as to require surgery.
For those women who do have symptoms severe enough to affect their overall quality of life, they may need to have some form of surgical treatment to alleviate the pain and other symptoms. It is necessary to fully evaluate each woman’s individual case before deciding on a course of action. The length and severity of the symptoms will of course be a factor as well as the woman’s desire for treatment the degree of the prolapse and whether or not she is healthy enough to undergo surgery.
Surgical Types and Issues
The goal of surgery is to provide the necessary support for your pelvic organs, and mesh is used in an attempt to reduce the risk of recurrence of the prolapse. Mesh typically offers a longer-lasting repair when all goes well and is successful in at least 80% of the POP surgeries it is used in. What the patient must remember is that mesh is a synthetic material and becomes a permanent part of the body.
The mesh has tiny holes which allow the body’s own tissue to grow into it, providing the necessary support framework. Women undergoing the surgery may have either general or regional anesthesia; incisions are made by the surgeon inside the vagina, and the surrounding tissues are strengthened with stitches. The mesh will be placed under the vaginal skin, and the tissues of the body will grow into the mesh within 3-4 weeks which provides the reinforcement needed for the weakened tissues.
Complications of Transvaginal Mesh Surgery
The complications of the mesh surgery result primarily from mesh erosion, meaning the mesh erodes into the vaginal walls or into other organs. This erosion can lead to severe—or in rare cases, even fatal—consequences, and typically requires another surgery to correct the erosion and remove the mesh patch. Women who have suffered mesh erosion from the transvaginal mesh surgery may experience repeated infections, chronic abdominal or back pain or urinary tract problems, and depending on the severity of the erosion could require multiple surgeries.
If the use of mesh has caused you to have severe complications, it is important that you first take care of your health then consult a reputable attorney who can evaluate the facts of your mesh surgery and determine whether you have a potential case.
Does Age Play a Role in Transvaginal Patch Complications?
In light of the many adverse events seen among women who have undergone transvaginal mesh surgeries in the past few years, the FDA is considering more stringent controls over approval of the device. Surgeons currently perform as many as 300,000 pelvic organ prolapse and stress urinary incontinence surgeries every year, a large portion of those using mesh in the procedure.
Who Suffers From Pelvic Organ Prolapse?
Women who have gone through childbirth multiple times as well as those who have undergone a hysterectomy or are going through menopause all seem to be more susceptible to pelvic organ prolapse. Additionally, those with a family history of pelvic organ prolapse could be more likely to suffer from POP. Although pelvic organ prolapse is generally a progressive condition which worsens and causes more serious symptoms, in some cases it does not progress and may actually improve with time. When estrogen levels diminish during and after menopause, pelvic organ prolapse is more likely to occur due to the fact that estrogen assists the body in making collagen, a protein which strengthens the supportive pelvic tissues. When there is less collagen in the body, the supportive tissues in the pelvis are more likely to appear, therefore when estrogen decreases, POP becomes more likely.
Is A Woman’s Age a Factor in Pelvic Organ Prolapse?
While older women will be more likely to suffer from POP simply by virtue of the fact that the connective tissues in the pelvic region have had more time to stretch and they have likely gone through childbirth and possibly even menopause or a hysterectomy, the surgery is also performed on women in their forties after giving birth multiple times. One particular study—done in 2002 which involved nearly 700 participants who received the transvaginal mesh patch—resulted in almost universal satisfaction following the procedure.
Some questioned the validity of these results since over four-fifths of the participants were post-menopausal and the average age was nearly 64. This is considered a relatively narrow group of study participants, especially in light of the fact that the procedure is often done on women of childbearing age following the stress of multiple pregnancies. It is likely that the older women were having much more serious symptoms of pelvic organ prolapse as a result of many years of downward gravity on the pelvic ligaments, therefore the relief they received from the surgery could have been more significant.
Who is Most Likely to Have Problems Following a Transvaginal Mesh Implant?
In one of the most comprehensive studies done to date, including nearly twelve thousand women, nearly ten percent of those had some sort of erosion of the implanted mesh within twelve months of the surgery, regardless of whether synthetic or biologic mesh was used in the surgery. It was found that factors which could predispose women to erosion problems included being a smoker or having a hysterectomy simultaneously with their POP surgery. Overall health is also a significant factor in surgery results. When a vaginal approach was used to place the mesh—as opposed to an abdominal incision—there tended to be more adverse results. Older women tended to have more incidences of mesh erosion, even though they were the group who reported the greatest satisfaction with the surgical results. Low estrogen levels—which typically occur in older women—were a factor in erosion as were the size of the mesh implant and the surgical technique variations or skill of the surgeon. Women who kept their uterus during the procedure appeared to have a lowered risk of erosion complications.
How Long Does it Take for Complications to Become Apparent?
Although every surgery and every woman is different, the majority of the mesh erosion problems seemed to develop at least a month post-op. Those who had the surgery via an abdominal incision became aware of erosion problems at around fifteen months, while those who had vaginal incision placement took only an average of four months to realize there were problems. Many women did not report the problems they were experiencing for longer periods of time, either due to embarrassment in discussing the issues with their doctor, or because they believed their problems would resolve in time.
How are Erosion Complications Treated?
Chronic pain, infections or an erosion of the mesh following a pelvic organ prolapse surgery usually requires subsequent surgeries. The typical treatment is to excise the mesh through an incision in the vagina, then re-sewing of the vaginal tissues. Women who only had a small area of erosion were additionally treated with a topical estrogen cream following the surgery. If the vaginal erosion was due to the insertion of a mesh sling, the sling will have to be removed, however this procedure can cause the original symptoms of pelvic organ prolapse to return.
The FDA believes that the number of women coming forward with adverse reports from transvaginal mesh is a significant cause for concern and advises women who have had the surgery to continue with regular check-ups and to notify their doctor if they have any unusual bleeding, discharge or pain. The future of the mesh patch is unclear at this point, however the lawsuits continue to mount.
Who Suffers From Pelvic Organ Prolapse?
Women who have gone through childbirth multiple times as well as those who have undergone a hysterectomy or are going through menopause all seem to be more susceptible to pelvic organ prolapse. Additionally, those with a family history of pelvic organ prolapse could be more likely to suffer from POP. Although pelvic organ prolapse is generally a progressive condition which worsens and causes more serious symptoms, in some cases it does not progress and may actually improve with time. When estrogen levels diminish during and after menopause, pelvic organ prolapse is more likely to occur due to the fact that estrogen assists the body in making collagen, a protein which strengthens the supportive pelvic tissues. When there is less collagen in the body, the supportive tissues in the pelvis are more likely to appear, therefore when estrogen decreases, POP becomes more likely.
Is A Woman’s Age a Factor in Pelvic Organ Prolapse?
While older women will be more likely to suffer from POP simply by virtue of the fact that the connective tissues in the pelvic region have had more time to stretch and they have likely gone through childbirth and possibly even menopause or a hysterectomy, the surgery is also performed on women in their forties after giving birth multiple times. One particular study—done in 2002 which involved nearly 700 participants who received the transvaginal mesh patch—resulted in almost universal satisfaction following the procedure.
Some questioned the validity of these results since over four-fifths of the participants were post-menopausal and the average age was nearly 64. This is considered a relatively narrow group of study participants, especially in light of the fact that the procedure is often done on women of childbearing age following the stress of multiple pregnancies. It is likely that the older women were having much more serious symptoms of pelvic organ prolapse as a result of many years of downward gravity on the pelvic ligaments, therefore the relief they received from the surgery could have been more significant.
Who is Most Likely to Have Problems Following a Transvaginal Mesh Implant?
In one of the most comprehensive studies done to date, including nearly twelve thousand women, nearly ten percent of those had some sort of erosion of the implanted mesh within twelve months of the surgery, regardless of whether synthetic or biologic mesh was used in the surgery. It was found that factors which could predispose women to erosion problems included being a smoker or having a hysterectomy simultaneously with their POP surgery. Overall health is also a significant factor in surgery results. When a vaginal approach was used to place the mesh—as opposed to an abdominal incision—there tended to be more adverse results. Older women tended to have more incidences of mesh erosion, even though they were the group who reported the greatest satisfaction with the surgical results. Low estrogen levels—which typically occur in older women—were a factor in erosion as were the size of the mesh implant and the surgical technique variations or skill of the surgeon. Women who kept their uterus during the procedure appeared to have a lowered risk of erosion complications.
How Long Does it Take for Complications to Become Apparent?
Although every surgery and every woman is different, the majority of the mesh erosion problems seemed to develop at least a month post-op. Those who had the surgery via an abdominal incision became aware of erosion problems at around fifteen months, while those who had vaginal incision placement took only an average of four months to realize there were problems. Many women did not report the problems they were experiencing for longer periods of time, either due to embarrassment in discussing the issues with their doctor, or because they believed their problems would resolve in time.
How are Erosion Complications Treated?
Chronic pain, infections or an erosion of the mesh following a pelvic organ prolapse surgery usually requires subsequent surgeries. The typical treatment is to excise the mesh through an incision in the vagina, then re-sewing of the vaginal tissues. Women who only had a small area of erosion were additionally treated with a topical estrogen cream following the surgery. If the vaginal erosion was due to the insertion of a mesh sling, the sling will have to be removed, however this procedure can cause the original symptoms of pelvic organ prolapse to return.
The FDA believes that the number of women coming forward with adverse reports from transvaginal mesh is a significant cause for concern and advises women who have had the surgery to continue with regular check-ups and to notify their doctor if they have any unusual bleeding, discharge or pain. The future of the mesh patch is unclear at this point, however the lawsuits continue to mount.
Transvaginal Mesh: A Brief History of the Problematic Implant
While the past three years have brought an influx of complications and problems related to the transvaginal mesh implant, the device has actually been in use for over half a century. Surgical mesh made of metallic or polymer screens was developed for use in abdominal hernia surgeries in the 1950’s, however gynecologists soon saw the advantages of using the mesh in the surgical repair of stress urinary incontinence and pelvic organ prolapse. These problems are relatively common among women who have had children, undergone a hysterectomy or are post-menopausal. During such events, the muscles and ligaments which surround the pelvic organs can weaken, allowing those organs to slip out of their natural place, or prolapse.
FDA Approves Surgical Mesh for Abdominal Surgeries
Surgical mesh was originally approved for abdominal applications; since pelvic organ prolapse surgeries were performed abdominally in the 70’s, the mesh appeared to be a good solution for POP surgeries as well. Prior to the development of mesh, hernia repair was performed using suture techniques which garnered recurrence rates from 24-54%. Once the mesh began to be widely used to repair hernias, the recurrence rates dropped to 10-20%, however placement and fixation of the mesh was crucial for a positive outcome. In the late 1980’s surgeons began positioning the mesh with an overlap of 5 cm in all directions around the hernia defect, and the recurrence rates dropped as low as 3.5%.
Transvaginal Use of Mesh
Following several decades of success in using the mesh implants, the 1990’s brought such great advances in surgical techniques as well as in the mesh technology itself that gynecologists began using the mesh in both SUI and POP transvaginal surgical procedures. At this time there was still no “official” surgical mesh product available for these procedures, therefore the surgeons simply cut the mesh themselves whenever they used the abdominal mesh in vaginal applications. Manufacturers of the mesh saw an opportunity, and began producing kits which included both the mesh as well as tools which supported the surgical delivery and insertion.
FDA Approval for Transvaginal Use
Actual FDA approval of the mesh for transvaginal surgeries did not take place until a mesh developed by Boston Scientific was approved in 1996 for use in stress urinary incontinence surgeries. Unfortunately, the year following that approval saw problems with this particular mesh product with over 120 patients reporting serious side effects. Even though Boston Scientific’s ProteGen was voluntarily pulled from the market in 1999, the manner in which FDA approval was granted allowed subsequent products to be approved using the ProteGen as a predicate device. Even though surgeons had been using mesh in pelvic organ prolapse surgeries for many years, it was finally granted FDA approval for this particular application in 2002.
Unexpected Problems Arise
Although for the most part the mesh products worked well in the areas of the abdomen which were limited in flex, the pelvis has a much different physiology. Pelvic regions such as the vagina tend to be highly flexible and much more delicate than the abdomen, and the stiff, inelastic mesh did not work as well with the fragile tissues. In many cases the mesh would shrink and become rigid, pulling at the delicate surrounding areas and even eroding through the tissue walls.
Today’s Mesh Implant Devices
There are four types of surgical mesh on the market today, the most common of which is made of a non-absorbable polyester or polypropylene mesh and used in most female urology surgeries. Other types include an absorbable, synthetic mesh, a mesh made of animal tissues and a mesh which is a combination of the other types. As many as half a million women each year undergo POP or SUI surgeries each year; in 2010 some 75,000 had POP surgery using the mesh in a transvaginal application while more than 200,000 had the procedure for stress urinary incontinence. There is a less common version of these procedures in which the surgeon implants the mesh through the abdomen and is believed by the FDA to produce fewer complications.
2008 Public Health Notification
The FDA issued a public health notice in October of 2008 in which they acknowledged a mistake in issuing a prior notice which called mesh problems “rare.” In the 2008 notification, more than a thousand adverse events were definitively associated with surgical mesh implants used in POP and SUI surgeries for the period from 2005-2007. From January, 2008 through December, 2010, the FDA received nearly three thousand more reports of complications from the mesh. Even when taking into consideration the fact that it is fairly common for adverse event reporting to increase following an FDA safety notification, the numbers were felt to be unduly high.
Mesh Use Today
Today many problems such as recurrent prolapse, mesh erosion, pain, infection, bleeding, urinary problems and pain during sexual intercourse are being reported. The FDA believes that such problems commonly occur within a year of the original surgery, and patients who experience complications may be subjected to multiple surgeries in order to successfully remove the mesh implant. After careful consideration the FDA advisory committee has suggested that the current transvaginal mesh products will remain on the market however more stringent warnings for use will be issued. Future products of this type will be forced to undergo stricter testing in order to be granted FDA approval.
FDA Approves Surgical Mesh for Abdominal Surgeries
Surgical mesh was originally approved for abdominal applications; since pelvic organ prolapse surgeries were performed abdominally in the 70’s, the mesh appeared to be a good solution for POP surgeries as well. Prior to the development of mesh, hernia repair was performed using suture techniques which garnered recurrence rates from 24-54%. Once the mesh began to be widely used to repair hernias, the recurrence rates dropped to 10-20%, however placement and fixation of the mesh was crucial for a positive outcome. In the late 1980’s surgeons began positioning the mesh with an overlap of 5 cm in all directions around the hernia defect, and the recurrence rates dropped as low as 3.5%.
Transvaginal Use of Mesh
Following several decades of success in using the mesh implants, the 1990’s brought such great advances in surgical techniques as well as in the mesh technology itself that gynecologists began using the mesh in both SUI and POP transvaginal surgical procedures. At this time there was still no “official” surgical mesh product available for these procedures, therefore the surgeons simply cut the mesh themselves whenever they used the abdominal mesh in vaginal applications. Manufacturers of the mesh saw an opportunity, and began producing kits which included both the mesh as well as tools which supported the surgical delivery and insertion.
FDA Approval for Transvaginal Use
Actual FDA approval of the mesh for transvaginal surgeries did not take place until a mesh developed by Boston Scientific was approved in 1996 for use in stress urinary incontinence surgeries. Unfortunately, the year following that approval saw problems with this particular mesh product with over 120 patients reporting serious side effects. Even though Boston Scientific’s ProteGen was voluntarily pulled from the market in 1999, the manner in which FDA approval was granted allowed subsequent products to be approved using the ProteGen as a predicate device. Even though surgeons had been using mesh in pelvic organ prolapse surgeries for many years, it was finally granted FDA approval for this particular application in 2002.
Unexpected Problems Arise
Although for the most part the mesh products worked well in the areas of the abdomen which were limited in flex, the pelvis has a much different physiology. Pelvic regions such as the vagina tend to be highly flexible and much more delicate than the abdomen, and the stiff, inelastic mesh did not work as well with the fragile tissues. In many cases the mesh would shrink and become rigid, pulling at the delicate surrounding areas and even eroding through the tissue walls.
Today’s Mesh Implant Devices
There are four types of surgical mesh on the market today, the most common of which is made of a non-absorbable polyester or polypropylene mesh and used in most female urology surgeries. Other types include an absorbable, synthetic mesh, a mesh made of animal tissues and a mesh which is a combination of the other types. As many as half a million women each year undergo POP or SUI surgeries each year; in 2010 some 75,000 had POP surgery using the mesh in a transvaginal application while more than 200,000 had the procedure for stress urinary incontinence. There is a less common version of these procedures in which the surgeon implants the mesh through the abdomen and is believed by the FDA to produce fewer complications.
2008 Public Health Notification
The FDA issued a public health notice in October of 2008 in which they acknowledged a mistake in issuing a prior notice which called mesh problems “rare.” In the 2008 notification, more than a thousand adverse events were definitively associated with surgical mesh implants used in POP and SUI surgeries for the period from 2005-2007. From January, 2008 through December, 2010, the FDA received nearly three thousand more reports of complications from the mesh. Even when taking into consideration the fact that it is fairly common for adverse event reporting to increase following an FDA safety notification, the numbers were felt to be unduly high.
Mesh Use Today
Today many problems such as recurrent prolapse, mesh erosion, pain, infection, bleeding, urinary problems and pain during sexual intercourse are being reported. The FDA believes that such problems commonly occur within a year of the original surgery, and patients who experience complications may be subjected to multiple surgeries in order to successfully remove the mesh implant. After careful consideration the FDA advisory committee has suggested that the current transvaginal mesh products will remain on the market however more stringent warnings for use will be issued. Future products of this type will be forced to undergo stricter testing in order to be granted FDA approval.
The ASR Acetabular System falls far short of other total hip replacement systems. Here's how.
In a previous article we wrote on bone deterioration, we discussed how the bones of your hip are constructed and how a hip implant strives to mimic the qualities so that you can maintain a normal range of movement and a fairly active life.
In this article, we'd like to show you how the ASR XL Acetabular System was constructed - and why it fell so short of what hip implant patients needed to give them back their previous quality of life.
What a Hip Implant is Up Against
Any hip implant is going head-to-head against the natural construction of your body, which is no easy feat. What we think of as our hip is actually two bones: the acetabulum (also called the hip socket) and the femoral head, which is the rounded top of your femur (the main bone that runs the length of your thigh).
hip1
As you can see, the two bones of your hip are actually attached to each other securely by two ligaments. The shorter ligament at the center of the femur head is the transverse acetabular ligament, while the longer ligament that runs from the ilium down to the femur itself is the iliofemoral ligament.
These ligaments, along with the cartilage surrounding the hip joint, are the reason your hip doesn't dislocate on a regular basis. The iliofemoral ligament in particular is extraordinarily strong - in fact, the strongest ligament in the human body - and when you are standing or sitting, this ligament flexes or releases to allow a range of movement without letting the hip move out of the socket.
For its part, the transverse acetabular ligament and the surrounding cartilage make up the acetabular labrum, whose purpose is to deepen the hip socket so that the head of the femur can't slip out. The deeper the hip socket, the more secure the femur bone becomes and the less likely your hip will dislocate.
When your natural hip is removed to make way for a hip implant, neither of those ligaments is in place, and the cushion of cartilage is removed to make way for an artificial replacement. Removing the labrum means that your hip is 92% more likely to suffer contact stresses and 40% more likely to allow the femur and acetabulum to touch.
As you can see, your hip is a sophisticated and well-constructed mechanism, and it is extremely difficult to create a man-made replacement for it. Let's take a look at some of the best attempts available in the form of conventional hip replacement and total hip replacement systems, including the ASR Acetabular System. Read more ....
In this article, we'd like to show you how the ASR XL Acetabular System was constructed - and why it fell so short of what hip implant patients needed to give them back their previous quality of life.
What a Hip Implant is Up Against
Any hip implant is going head-to-head against the natural construction of your body, which is no easy feat. What we think of as our hip is actually two bones: the acetabulum (also called the hip socket) and the femoral head, which is the rounded top of your femur (the main bone that runs the length of your thigh).
hip1
As you can see, the two bones of your hip are actually attached to each other securely by two ligaments. The shorter ligament at the center of the femur head is the transverse acetabular ligament, while the longer ligament that runs from the ilium down to the femur itself is the iliofemoral ligament.
These ligaments, along with the cartilage surrounding the hip joint, are the reason your hip doesn't dislocate on a regular basis. The iliofemoral ligament in particular is extraordinarily strong - in fact, the strongest ligament in the human body - and when you are standing or sitting, this ligament flexes or releases to allow a range of movement without letting the hip move out of the socket.
For its part, the transverse acetabular ligament and the surrounding cartilage make up the acetabular labrum, whose purpose is to deepen the hip socket so that the head of the femur can't slip out. The deeper the hip socket, the more secure the femur bone becomes and the less likely your hip will dislocate.
When your natural hip is removed to make way for a hip implant, neither of those ligaments is in place, and the cushion of cartilage is removed to make way for an artificial replacement. Removing the labrum means that your hip is 92% more likely to suffer contact stresses and 40% more likely to allow the femur and acetabulum to touch.
As you can see, your hip is a sophisticated and well-constructed mechanism, and it is extremely difficult to create a man-made replacement for it. Let's take a look at some of the best attempts available in the form of conventional hip replacement and total hip replacement systems, including the ASR Acetabular System. Read more ....
Many patients who received a DePuy hip implant have suffered heavy metal poisoning. But what does that really mean?
As we try to describe the reasons the DePuy ASR XL Acetabular System present such a danger to your health, we occasionally use terms you may be only vaguely familiar with. This is an ongoing series of articles on the medical terms related to the DePuy hip recall and hip revision surgeries.
Heavy metal poisoning, by its strictest definition, is simply the build-up of heavy metals in the soft tissues of the body. It is also referred to as heavy metal toxicity. The most common heavy metals associated with poisoning are lead, mercury, arsenic, and cadmium; the ones that are in the structure of the DePuy ASR XL Acetabular hip implant are chromium and cobalt.
One doctor who analyzed several patients who were tested for metal poisoning said that these were some of the highest levels for chromium and cobalt ions he has ever seen. Despite this, he also said that many of the patients had no symptoms, which makes for a very good argument that any patients who received an ASR XL Acetabular System should be monitored closely and receive regular blood tests.
For any kind of heavy metal poisoning, the symptoms largely revolve around the digestive system: nausea, vomiting, diarrhea, and stomach pain, for example. Patients may also have headaches or get a metallic taste in their mouths. In extreme cases, heavy metal poisoning may make patients lose cognitive, motor, and language function.
Chromium and cobalt have also both been linked to cancer. One study recommended that human beings should not have more than 1 part per million of cobalt or chromium in the bloodstream many patients with the ASR XL Acetabular System have exceeded 7 parts per million.
The standard treatment for metal poisoning is chelation therapy; however, this process does not reverse any neurological damage done.
Heavy metal poisoning, by its strictest definition, is simply the build-up of heavy metals in the soft tissues of the body. It is also referred to as heavy metal toxicity. The most common heavy metals associated with poisoning are lead, mercury, arsenic, and cadmium; the ones that are in the structure of the DePuy ASR XL Acetabular hip implant are chromium and cobalt.
One doctor who analyzed several patients who were tested for metal poisoning said that these were some of the highest levels for chromium and cobalt ions he has ever seen. Despite this, he also said that many of the patients had no symptoms, which makes for a very good argument that any patients who received an ASR XL Acetabular System should be monitored closely and receive regular blood tests.
For any kind of heavy metal poisoning, the symptoms largely revolve around the digestive system: nausea, vomiting, diarrhea, and stomach pain, for example. Patients may also have headaches or get a metallic taste in their mouths. In extreme cases, heavy metal poisoning may make patients lose cognitive, motor, and language function.
Chromium and cobalt have also both been linked to cancer. One study recommended that human beings should not have more than 1 part per million of cobalt or chromium in the bloodstream many patients with the ASR XL Acetabular System have exceeded 7 parts per million.
The standard treatment for metal poisoning is chelation therapy; however, this process does not reverse any neurological damage done.
The DePuy ASR XL Acetabular hip replacement system was FDA approved - which might be more cause for worry than relief.
Since 1976, all medical devices must be classified and approved by the U.S. Food and Drug Administration (FDA) before they can be legally marketed to the public. It is the fond belief of many Americans that FDA approval is a ringing endorsement of a product's safety, a guarantee that the device has been tested and re-tested by professionals who are presumably trained to put the device through all kinds of rigor to triple-check its safety and effectiveness before allowing it anywhere near our fragile human bodies.
It is, as we say, a fond belief, but not an accurate one. It seems that many medical devices - including the recently recalled DePuy ASR XL Acetabular System - are given an FDA approval and subsequently placed inside people's bodies without ever going through a single test at the FDA.
The FDA department responsible for the regulation and review of medical devices is the Center for Devices and Radiological Health (CDRH). CDRH divides medical devices into three classes: life-sustaining, life-supporting or implantable devices are designated as Class III.
Hip replacements, including the ASR XL system, qualify as a Class III device and are considered high risk to the patient's health.
Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process (PMA) is more or less what we think of when we imagine our device being tested by the FDA: an extensive review including rigorous clinical trials that show it to be safe for use in humans. The PMA is quite detailed, lengthy, and expensive, usually costing the manufacturing company upwards of $250,000 and taking as much as two years to complete.
A quarter of a million is a large chunk of change - but thankfully for companies with a firm eye on their bottom line, there's always the second FDA approval process.
The premarket notification approval process, also known as the 510(k) approval process, is a sort of shortcut to approval that lowers the price point considerably - and also, conveniently, doesn't involve any pesky testing that might reveal a flaw in the product that would then have to be revamped and retested for another quarter-million.
The 510(k) process basically pre-approves any product that is deemed "substantially equivalent" to another product already legally approved for sale. It costs less than $5,000, requires no clinical trials, and only takes an average of 3-6 months to complete. It's a good shortcut for products that are essentially identical to their forebears. After all, it hardly makes sense to waste the FDA's time when they could be helping get new, innovative, life-saving products to market. But what's to stop companies from claiming their products are "substantially equivalent" to other FDA-approved devices even if they're not remotely the same? Read more .....
It is, as we say, a fond belief, but not an accurate one. It seems that many medical devices - including the recently recalled DePuy ASR XL Acetabular System - are given an FDA approval and subsequently placed inside people's bodies without ever going through a single test at the FDA.
The FDA department responsible for the regulation and review of medical devices is the Center for Devices and Radiological Health (CDRH). CDRH divides medical devices into three classes: life-sustaining, life-supporting or implantable devices are designated as Class III.
Hip replacements, including the ASR XL system, qualify as a Class III device and are considered high risk to the patient's health.
Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process (PMA) is more or less what we think of when we imagine our device being tested by the FDA: an extensive review including rigorous clinical trials that show it to be safe for use in humans. The PMA is quite detailed, lengthy, and expensive, usually costing the manufacturing company upwards of $250,000 and taking as much as two years to complete.
A quarter of a million is a large chunk of change - but thankfully for companies with a firm eye on their bottom line, there's always the second FDA approval process.
The premarket notification approval process, also known as the 510(k) approval process, is a sort of shortcut to approval that lowers the price point considerably - and also, conveniently, doesn't involve any pesky testing that might reveal a flaw in the product that would then have to be revamped and retested for another quarter-million.
The 510(k) process basically pre-approves any product that is deemed "substantially equivalent" to another product already legally approved for sale. It costs less than $5,000, requires no clinical trials, and only takes an average of 3-6 months to complete. It's a good shortcut for products that are essentially identical to their forebears. After all, it hardly makes sense to waste the FDA's time when they could be helping get new, innovative, life-saving products to market. But what's to stop companies from claiming their products are "substantially equivalent" to other FDA-approved devices even if they're not remotely the same? Read more .....
Taking Charge: A Blueprint for DePuy Hip Implant Recipients to Follow for Successful Recovery
Taking Charge: A Blueprint for DePuy Hip Implant Recipients to Follow for Successful Recovery
Introduction:
While the FDA began receiving complaints regarding the failure of hip replacement devices manufactured by DePuy Orthopedics (a subsidiary of Johnson & Johnson) for some time, there was not a DePuy hip extensive recall on the device until August of 2010. Many feel the recall should have come much sooner and that the company knew there were issues with the implant for a significant period of time before they issued the recall. Many of the patients who have been implanted with a DePuy hip replacement device later required a second surgery when their original implant failed. This DePuy hip implant failure has negatively affected the quality of life for its recipients.
Introduction:
While the FDA began receiving complaints regarding the failure of hip replacement devices manufactured by DePuy Orthopedics (a subsidiary of Johnson & Johnson) for some time, there was not a DePuy hip extensive recall on the device until August of 2010. Many feel the recall should have come much sooner and that the company knew there were issues with the implant for a significant period of time before they issued the recall. Many of the patients who have been implanted with a DePuy hip replacement device later required a second surgery when their original implant failed. This DePuy hip implant failure has negatively affected the quality of life for its recipients.
“Hip” Definitions: A Discussion of Medical Terms Every DePuy Hip Implant Recipient Should Know
“Hip” Definitions: A Discussion of Medical Terms Every DePuy Hip Implant Recipient Should Know
Introduction
July of 2003 saw the worldwide introduction of the metal-on-metal hip replacement by DePuy, although these devices were not used for hip replacement surgeries in the United States until 2005. Johnson & Johnson, the parent company of DePuy, pushed the approval of the hip implant device through the FDA under an expedited process known as the 510(k). This process allows many medical devices to skip rigorous clinical trials when the manufacturer can show the device is substantially equivalent to another device which has already received approval. At the time of the 510(k) approval, DePuy claimed the ASR hip replacement device raised no new issues of safety or effectiveness.
Complaints Regarding the DePuy Implant
Over the next few years, the FDA began receiving a flood of complaints regarding these devices, and many of the DePuy metal-on-metal hip implants had to be removed for the health of the recipient. Although a traditional metal-on-metal hip implant device can reasonably be expected to last at least fifteen years, the DePuy devices were failing at a much higher—and earlier—rate. Even though DePuy was notified of the health issues surrounding the implant as early as 2007, they continued to market the hip implants until August 26, 2010, when DePuy and Johnson & Johnson finally issued a voluntary Depuy hip extensive recall of the implant system. Those who have undergone the hip implant surgery with a DePuy implant may be confused regarding the potential health risks and uncertain of how to proceed and should be aware that a DePuy hip replacement lawsuit is an option.
Introduction
July of 2003 saw the worldwide introduction of the metal-on-metal hip replacement by DePuy, although these devices were not used for hip replacement surgeries in the United States until 2005. Johnson & Johnson, the parent company of DePuy, pushed the approval of the hip implant device through the FDA under an expedited process known as the 510(k). This process allows many medical devices to skip rigorous clinical trials when the manufacturer can show the device is substantially equivalent to another device which has already received approval. At the time of the 510(k) approval, DePuy claimed the ASR hip replacement device raised no new issues of safety or effectiveness.
Complaints Regarding the DePuy Implant
Over the next few years, the FDA began receiving a flood of complaints regarding these devices, and many of the DePuy metal-on-metal hip implants had to be removed for the health of the recipient. Although a traditional metal-on-metal hip implant device can reasonably be expected to last at least fifteen years, the DePuy devices were failing at a much higher—and earlier—rate. Even though DePuy was notified of the health issues surrounding the implant as early as 2007, they continued to market the hip implants until August 26, 2010, when DePuy and Johnson & Johnson finally issued a voluntary Depuy hip extensive recall of the implant system. Those who have undergone the hip implant surgery with a DePuy implant may be confused regarding the potential health risks and uncertain of how to proceed and should be aware that a DePuy hip replacement lawsuit is an option.
Johnson & Johnson Takes $3 Billion Dollar Fourth Quarter Charge
Johnson & Johnson Takes $3 Billion Dollar Fourth Quarter Charge
Introduction
Johnson & Johnson, the parent company of DePuy Orthopedics recently took a fourth quarter charge of over $3 billion dollars related primarily to their voluntary recall artificial hip implants—the DePuy ASR Acetabular System and the ASR Hip Resurfacing System. The recall took place in August of 2010, after the FDA had received incident reports regarding the DePuy metal-on-metal hip implants for over two years. Approximately one in eight patients—and possibly more—will require a hip revision surgery to remove the faulty DePuy device and replace it with another hip implant device. Unfortunately, most patients have a longer recovery time and more medical issues related to the second revision surgery than they did with the first.
Introduction
Johnson & Johnson, the parent company of DePuy Orthopedics recently took a fourth quarter charge of over $3 billion dollars related primarily to their voluntary recall artificial hip implants—the DePuy ASR Acetabular System and the ASR Hip Resurfacing System. The recall took place in August of 2010, after the FDA had received incident reports regarding the DePuy metal-on-metal hip implants for over two years. Approximately one in eight patients—and possibly more—will require a hip revision surgery to remove the faulty DePuy device and replace it with another hip implant device. Unfortunately, most patients have a longer recovery time and more medical issues related to the second revision surgery than they did with the first.
Recall of Artificial Hip Causes Johnson & Johnson 2012 Earnings Forecast to Dip
Recall of Artificial Hip Causes Johnson & Johnson 2012 Earnings Forecast to Dip
Introduction
The pharmaceutical giant, Johnson & Johnson, has been given a 2012 earnings forecast which is below the previous estimates present by financial analysts due to the number of DePuy hip replacements which were recalled. In fact, recent reports state Johnson & Johnson takes $3 billion charge for hip recall. In 2010 it was discovered that the DePuy metal-on-metal hip replacement devices were shedding metal fragments and Johnson & Johnson issued a recall for those particular hip replacements. The metal fragments which were shed into the body were found to cause disabling injuries in some recipients, and the toxicity from the chromium and cobalt debris can cause the surrounding tissues to suffer necrosis or death.
Introduction
The pharmaceutical giant, Johnson & Johnson, has been given a 2012 earnings forecast which is below the previous estimates present by financial analysts due to the number of DePuy hip replacements which were recalled. In fact, recent reports state Johnson & Johnson takes $3 billion charge for hip recall. In 2010 it was discovered that the DePuy metal-on-metal hip replacement devices were shedding metal fragments and Johnson & Johnson issued a recall for those particular hip replacements. The metal fragments which were shed into the body were found to cause disabling injuries in some recipients, and the toxicity from the chromium and cobalt debris can cause the surrounding tissues to suffer necrosis or death.
Things You Should Know About Johnson & Johnson’s and DePuy Orthopedics’ Attempts to Help Hip Implant Recipients
Things You Should Know About Johnson & Johnson’s and DePuy Orthopedics’ Attempts to Help Hip Implant Recipients
Introduction
DePuy hip implants were used widely throughout the world, beginning in 2003, and in the United States from 2005. Although concerns were raised regarding the safety of these hip implant devices, a recall by DePuy was not issued until August of 2010 when DePuy received data from the National Joint Registry showing the five year revision rate for the ASR hip replacement system was approximately 12-13%. This study appeared to show that the risks for revision surgery were highest among female patients who received the smaller ASR heads which were less than 50mm in diameter. The recall in 2010 was voluntary on the part of DePuy and Johnson and Johnson and the pharmaceutical giant has subsequently issued several field safety notices to physicians to enable them to help their patients whose health has been affected by the DePuy hip implant failure.
Introduction
DePuy hip implants were used widely throughout the world, beginning in 2003, and in the United States from 2005. Although concerns were raised regarding the safety of these hip implant devices, a recall by DePuy was not issued until August of 2010 when DePuy received data from the National Joint Registry showing the five year revision rate for the ASR hip replacement system was approximately 12-13%. This study appeared to show that the risks for revision surgery were highest among female patients who received the smaller ASR heads which were less than 50mm in diameter. The recall in 2010 was voluntary on the part of DePuy and Johnson and Johnson and the pharmaceutical giant has subsequently issued several field safety notices to physicians to enable them to help their patients whose health has been affected by the DePuy hip implant failure.
New Updates for DePuy Hip Implant Victims
New Updates for DePuy Hip Implant Victims
The DePuy ASR Litigation Status Conference
On January 23, 2012, the DePuy ASR Litigation Status Conference in West Palm Beach, Florida was held before Judge David Katz. Judge Katz is the United States Federal District Judge assigned by the Multi District Litigation panel of judges to hear all pretrial matters in any DePuy ASR cases filed in federal court.
Judge Katz met with the Executive Committee of the Plaintiffs’ Steering Committee for about an hour privately before he met with all attorneys in open court. The Plaintiffs’ Steering Committee are the dozen or so lawyers Judge Katz assigned as leaders of all plaintiffs’ lawyers who have filed cases in the ASR litigation. The Plaintiffs’ Steering Committee is responsible for gathering evidence (Johnson and Johnson and others have turned over approximately 18,000,000 documents so far), taking depositions of fact and expert witnesses, legal analysis, submitting briefs to the court, and a variety of other tasks.
The DePuy ASR Litigation Status Conference
On January 23, 2012, the DePuy ASR Litigation Status Conference in West Palm Beach, Florida was held before Judge David Katz. Judge Katz is the United States Federal District Judge assigned by the Multi District Litigation panel of judges to hear all pretrial matters in any DePuy ASR cases filed in federal court.
Judge Katz met with the Executive Committee of the Plaintiffs’ Steering Committee for about an hour privately before he met with all attorneys in open court. The Plaintiffs’ Steering Committee are the dozen or so lawyers Judge Katz assigned as leaders of all plaintiffs’ lawyers who have filed cases in the ASR litigation. The Plaintiffs’ Steering Committee is responsible for gathering evidence (Johnson and Johnson and others have turned over approximately 18,000,000 documents so far), taking depositions of fact and expert witnesses, legal analysis, submitting briefs to the court, and a variety of other tasks.
Hip Replacement Implant Complaints on the Rise
Hip Replacement Implant Complaints on the Rise
Hip replacement is a common orthopedic surgical procedure performed to relieve pain and restore mobility to a damaged hip joint, typically for patients with arthritis or a hip injury. Diseased or damaged portions of the hip ball and socket joint are replaced by prostheses made of metal, ceramic, plastic, or combinations of these materials. Metal-on-metal (MoM) hip replacement implants use ball and socket components that are both made of cobalt or chromium metal, or titanium. The ball fits into and glides against the surface of the socket to imitate the function of the hip joint.
Hip replacement surgery is mostly successful, and hip implants are made to last 15 or more years before replacement is required. There are risks of several complications that can occur, however; as with any type of surgery. Complications that can occur include infection, dislocation of the ball implant from the socket, and implant loosening or other wear and tear over time requiring another hip replacement surgery.
Holly Soehnge is a Texas
lawyer and part-time staff writer for Sullo & Sullo. She
additionally holds a doctorate in biochemistry. Her writing has been
published in legal and scientific journals including the FDA Food &
Drug Law Journal and Proceedings of the National Academy of Sciences.
Hip replacement is a common orthopedic surgical procedure performed to relieve pain and restore mobility to a damaged hip joint, typically for patients with arthritis or a hip injury. Diseased or damaged portions of the hip ball and socket joint are replaced by prostheses made of metal, ceramic, plastic, or combinations of these materials. Metal-on-metal (MoM) hip replacement implants use ball and socket components that are both made of cobalt or chromium metal, or titanium. The ball fits into and glides against the surface of the socket to imitate the function of the hip joint.
Hip replacement surgery is mostly successful, and hip implants are made to last 15 or more years before replacement is required. There are risks of several complications that can occur, however; as with any type of surgery. Complications that can occur include infection, dislocation of the ball implant from the socket, and implant loosening or other wear and tear over time requiring another hip replacement surgery.
What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?
What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean? Letter to Hip Makers Mean?
The U.S. FDA ordered 21 manufacturers to collect information from patients.
The U.S. FDA ordered 21 manufacturers to collect information from patients in a recent letter to hip manufacturers. Click here for report.
The three-page letter demands blood tests and other studies within
thirty days. Here is a summary of the information and questions the FDA
is requiring from manufacturers:
Subscribe to:
Posts (Atom)