“ASR” type Chromium and Cobalt Poisoning also being seen in Pinnacle Hip Implant Recipients

The DePuy ASR metal-on-metal hip implant has repeatedly made the news following a voluntary recall on August 26, 2010. While DePuy’s Pinnacle metal hip implant has not suffered under the recall stigma, many feel that it offers the same risks to implant recipients as the ASR. And, in fact, many attorneys are constantly asked by their clients about the differences between the ASR and the Pinnacle. The primary distinction between the two metal hip devices lies in the fact that the Pinnacle uses an insert liner between the acetabular cup and the femoral head while the ASR does not. It has been theorized that the ASR cup was too shallow for the head, leading to the ball hitting the edge of the cup and metal shavings to shear off into the body, also know as edge-loading.

While the Pinnacle’s cup was designed to give greater depth and allow the femoral head to move more freely within the socket, in some cases it still has been know to cause metallosis in implant recipients when the cobalt and chromium ions migrate around the body. Metal poisoning can cause a wide variety of adverse medical events. Many ASR recipients have had cardiovascular, renal, neurological and thyroid issues although studies done in the 70’s do not definitively tie these metals to cancer. Unfortunately, due to the lack of comprehensive studies on safe levels of cobalt and chromium in the body and the effects of toxic levels, nobody really knows just how dangerous these metals can be should they migrate to the bloodstream. The metal shards can also lodge into the surrounding tissues causing degeneration and destruction. 

Chromium and Cobalt Poisoning: What are the Long Term Side Effects of Metallosis?

It is likely that the recipients of a metal-on-metal hip implant have heard about the possible consequences from the metal shavings which can be released into the body when the metal cup and ball rub against one another during normal activities. Tiny ions of cobalt and chromium shear off when the two surfaces meet and those ions can lodge in the surrounding tissues or can end up in the bloodstream. As more and more metal hip implant patients are realizing the seriousness of metal toxicity, blood testing for elevated levels of metals is increasing. In many cases patients have been found to have levels of cobalt and chromium in their bloodstream which are as much as a hundred times normal levels. 

Although slightly elevated levels of these metals are fairly normal for patients with metal-on-metal hip implants, extreme elevations can be very dangerous—and anxiety-producing for the patient. DePuy released a report indicating that concentrations of the metals greater than 7 parts per billion are cause for concern. The Mayo Clinic has set somewhat different reference values, stating that blood serum concentrations of chromium greater than 1ng/mL suggests significant wear of the metal implant while serum concentrations greater than 5.0 ng/mL of cobalt can be considered toxic and also suggest significant wear of the prosthesis. Remember that 1 PPB (part per billion) equals 1.0 ng/mL.

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.

Transvaginal Mesh: Are There Safer Alternatives?

In light of the recent lawsuits filed against manufacturers of transvaginal mesh implants, many are wondering whether a safer alternative to using the potentially risky mesh exists. Mesh has been used since the 1950’s, primarily for hernia surgeries which are performed abdominally. Surgeons began expanding the use of the mesh to include surgeries on women for pelvic organ prolapse or stress incontinence. Women who had given birth multiple times, undergone a hysterectomy or were in menopause often experienced difficulties when their internal organs prolapsed as a result of the overstretched muscles and ligaments. The mesh once used solely for hernia repair was now being simply cut to a different size or shape and used in these POP and SUI surgeries, where surgeons fashioned the mesh into a support for the prolapsed organ. As time passed, the surrounding tissues would grow into the mesh, creating a permanent solution to keeping the organs in their place.

Complications from Transvaginal Mesh

After decades of using the mesh in transvaginal applications, complications from the mesh began surfacing. After carefully reviewing adverse event reports as well as the handful of studies done on the safety of the mesh implants the FDA issued a safety warning in 2008 declaring that complications from the mesh implants were not as rare as once believed. In the past several years over 4,000 women have reported complications from the mesh, primarily a particularly serious issue known as erosion when the mesh works its way through the vaginal wall and even into other surrounding organs. Other complications include infection, chronic urinary tract infections and pain, ranging from moderate to chronic and severe.

Is There a Safer Alternative?

A wide range of research has been done regarding the benefits of one type of surgery over the other, with most results indicating that the use of mesh implants in POP or SUI surgeries is not superior to more traditional methods. Similarly, an FDA review of the scientific literature regarding vaginal mesh use in surgeries taking place between 1996 and 2011 found that transvaginal repair with mesh improves neither the end result nor the quality of life when compared to traditional, non-mesh repairs. One study, published in The New England Journal of Medicine found that the mesh approach rendered more effective relief of symptoms, however noted a higher incidence of subsequent complications from the mesh surgeries. Over 300,000 POP and SUI surgeries are performed each year in the United States, however many of the women undergoing these surgeries are not fully informed of the alternatives to mesh surgery as well as the possible complications.

History of Pelvic Organ Prolapse Surgery

For over five decades surgeons have been performing a procedure to repair pelvic organ prolapse which includes an abdominal incision and using the woman’s own tissues to tack up and hold the dropping pelvic organs where they should be. This procedure generally required a hospital stay of several days as well as a recovery time which could be as long as several months. Later, a device known as a laparoscope was used in POP surgeries. The laparoscope is a length of tube with a camera on one end. When it is placed inside the body, the laparoscope allows the surgeon to repair the damage without making large incisions in the abdomen. When using this device the scope and instruments are inserted through small holes in the body, the procedure is outpatient and recovery time is about two weeks. Using mesh in the surgeries can be done either through an abdominal incision or vaginal incision although the failure rates tend to be higher in those procedures done vaginally.

Comparing Traditional Surgery to Mesh

One study contrasted traditional prolapse surgery with mesh surgery in nearly 400 women; over half of the women were chosen for surgery using the mesh implant while the other women underwent more traditional surgery methods. The outcome of the study indicated that while there were better outcomes with respect to prolapse symptoms when the mesh was used, there were significant complications from the mesh both during the surgery and later. One surgeon noted that although the new transvaginal mesh surgery offered clear advantages over traditional surgery methods, the risk of complications from mesh made it imperative that the patient be fully informed and that all pros and cons be carefully weighed.

The Burch Procedure

A procedure known as the Burch procedure has been found to be a safer surgical alternative to transvaginal mesh implants in the treatment of stress urinary incontinence. This procedure uses the more traditional method of suturing the ligaments surrounding the bladder to hold up the tissues beside the urethra and can be done via an incision in the abdomen, laparoscopically or vaginally, and although the Burch procedure does not appear to be more effective than mesh, it may alleviate the safety concerns of using mesh implants.

The FDA will soon make their decision about whether the mesh devices need to be subjected to more stringent rules and regulations however in the meantime the lawsuits continue to stack up.

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.

As recall after recall appears in the news, it becomes clear Johnson & Johnson cares more about sales than safety.

Johnson & Johnson's slogans over the years have assured consumers, particularly mothers, that their products are - above all else - safe. However, a recent, seemingly endless stream of recalls suggests otherwise.

Children's Tylenol, Motrin Infant Drops, and Children's Benadryl are among the many medications recalled this year for manufacturing and labeling issues. Those products join recalls of Acuvue contact lenses, the allergy medication Zyrtec, and the ASR hip implant, which was sold to approximately 93,000 adults needing hip replacement surgery. A consistent pattern emerges: the company recalls products only as a last resort, and its quality controls seem to allow an inordinate number of dangerous products to reach the market - and enter the bodies of consumers.

J&J may once have cared that its products were safe. Now, it appears the company only cares if they're sold. The company consistently sells products long after it is fully aware that the products present a danger to the public.

And the FDA is helping.

Silent Recalls

In a report by ABC News, an inventory company employee named Lynn Walther tells reporters that J&J hired him to quietly purchase specific lots of Motrin IB. His instructions stated that he should, "simply act like a regular customer while making these purchases. There must be no mention of this being a recall of the product. Run in, find the product, make your purchase and run out."

Johnson & Johnson's Head of Consumer Affairs, Colleen Goggins, stated that the company had nothing to do with the buy-back, and that she didn't "believe there was any intent to mislead or hide anything." It's difficult to believe the now-retired Goggins, considering J&J has a long history of "phantom" or "silent" recalls.

In 2007, the Australia joint registry sent seven separate reports to the company identifying specific problems with the ASR device and detailing the high failure rate. The device was withdrawn for "commercial reasons" in December of 2009 and only officially recalled in March of 2010. Meanwhile, thousands of people received an implant that may cause permanent tissue and bone damage or require a revision, which could mean they will be unable to have a successful future implant.

Other recalls show a similar pattern of attempting to minimize the amount of product recalled - or avoid a recall altogether. Where one might hope that a company would issue a recall as rapidly as possible after being informed of problems, J&J's usual response is to "wait and see", followed by an attempt to remove the product by some other means than a recall. If it does recall the product, the company issues the smallest recall possible, expanding by minute degrees to keep products on the shelves as long as possible.

Hundreds of wrongful death claims were issued over the Duragesic pain-killing patch. The jury determined that J&J was aware of the defects in the Duragestic patches, but neglected to inform doctors and consumers. the company recalled the patch that administered a 75mg/hour dose in 2004 - and waited until 2008 to recall the same patch that administered a 25mg/hour dose.

In Japan, J&J expanded a recall of its Acuvue TruEye lenses five times, from the initial 100,000 boxes to half a million. The expanded recall was only announced in Japan. At the time of the recall notice, J&J rather cavalierly noted that the recall represented less than 1% of all contact lenses made by the company worldwide.

This fact is surely a great comfort to the 500,000 people who put acidic lenses in their eyes. We're surprised a similar statement was not made about the Duragesic pain-killing patches; surely the hundreds of people who died represented only a small - negligible, really - fraction of the product consumed worldwide.

When it comes to consumer safety, though, Johnson & Johnson would almost always prefer to look at the numbers than the people.

Fine Print in Invisible Ink

Johnson & Johnson has been reprimanded, and occasionally sued, repeatedly over the last ten years for not giving their customers adequate warning about the risks of their products. Many jokes are made about reading the fine print - but the fine print can be rather difficult to read if the warnings simply aren't put on the labels at all. 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.

“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.

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.

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.

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.

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.

Hip Replacement Implant Complaints on the Rise

Hip Replacement Implant Complaints on the Rise

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.

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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:

Will New FDA Orders Lead to a Recall of All Metal-on-Metal Hip Implants?

Will New FDA Orders Lead to a Recall of All Metal-on-Metal Hip Implants?

U.S. Food and Drug Administration orders 21 hip makers to blood test their patients for metal.

The U.S. Food and Drug Administration, the governmental organization that protects public health, entered the battlefield with the Johnson & Johnson's DePuy recall and ordered 21 manufacturers to collect information from patients - including blood tests for metallic ions. This broad use of the agency's authority will clarify failure rates of metal-on-metal implants and drop the hammer on Johnson & Johnson.

"This is a disaster for J&J," said James Moriarty, senior partner at Moriarty Leyendecker. "It will be a public health nightmare and show how metal-on-metal hip implants can cause metallosis." (the swelling around metal implants as a result of corrosion or an allergic reaction).