Extraction Protocol Regarding Stryker ABG II Hip Implants

When the Stryker ABG II was originally marketed it was believed to be a safe alternative to the metal-on-metal hip implants which caused so much damage to recipients. Even though the ABG II does not have the same amount of metal surface to rub together, some of the metal neck junctures have shown signs of corrosion and the metal trunnions, located on either end of the neck portion have also been subject to corrosion when body fluids become trapped underneath.  Once corrosion and fretting occur, the threat of tissue necrosis, bone loss, total implant failure and symptoms of metal toxicity can follow.

Initially surgeons were impressed with the ABG II and the Rejuvenate because of the new modular design which allowed them to choose a stem, neck, ball and cup based on the activity level and size of the individual recipient. This extra flexibility was also meant to give patients a better, longer-lasting hip implant. Unfortunately, the promise of this new design did not pan out, and soon many recipients of the ABG II began to experience inflammation and pain as well as symptoms of metal toxicity.  Those patients who experienced significant problems early on were likely advised to undergo revision surgery in order to remove the Stryker ABG II, however this is not the easy decision it might seem despite the serious adverse symptoms.

Because of the weakened bone and tissue which results from corrosion of the ABG II, there is a significant risk of dislocation following revision surgery. In many Stryker ABG II revision surgeries the femur bone will fracture from the stress of removing the stem of the implant. Revision of the ABG II is considered much riskier than the original hip replacement surgery as the process is much more complex. The ABG II revision surgery can take much longer than the original hip replacement surgery which increases risk of infection and blood loss.

There is a protocol for the removal of the Stryker ABG II which includes removal of the neck implant piece with an ABG II Modular Neck Extractor which is placed under the medial or lateral side of the base of the neck. Neck Trial Forceps are recommended as a means of “catching” the neck during the extraction; should the neck be resistant to removal it is recommended that the Neck Extractor end be tapped in a controlled manner with a mallet. The stem of the Stryker ABG II will next be removed using a Modular Stem Extractor with a connection pin which engages the stem insertion feature and incorporates a locking arm which engages the taper. The threaded locking knob will be tightened which secures the arm. Finally, the stem impactor will push the stem from where it is inserted into the femur.

Extracting the stem is likely the most difficult part of the revision surgery and some orthopedic surgeons have likened it to removing a piece of rebar from a slab of concrete. Stryker ABG II revision surgery can require extra bone material obtained from a bone bank when the stem is removed as the bone can shatter. Because of the additional recovery time, patients who undergo revision surgery to remove a defective ABG II can face exorbitant medical expenses, lost wages from their inability to return to work, short or long-term disabilities and interruptions to their daily routines for considerable lengths of time.

Information and Actions to Consider Regarding the Stryker ABG II and Rejuvenate Hip Implants

This past July, both the Stryker ABG II and the Rejuvenate hip implants were recalled due to the risk of fretting and corrosion. When corrosion occurs inflammation can result, the recipient may experience chronic pain and tissue and bone degradation and loss can occur. When the bone and tissue around the hip implant begin to deteriorate, the implant can loosen and total failure of the implant can occur. Many patients have experienced implant failure and have been advised by their physician they must undergo revision surgery to have the recalled implant removed and replaced with a ceramic or polyethylene hip device.

Other patients have experienced metal toxicity when the microscopic metal shards enter the bloodstream and cause gastrointestinal, cardiovascular, renal and thyroid problems as well as vision and hearing disturbances, vertigo, DNA disruption, anxiety, depression and irritability. There are certain things you must do in order to protect your right to compensation should you have already had problems with your Stryker implant or have problems in the future.

If you do not already know the name of the surgeon who performed your initial hip implant, it’s important to find that information as he or she could be called to testify during a lawsuit. Whether you have had problems yet or not, see your physician for a complete medical workup and diagnosis to determine your levels of cobalt and chromium and to find out whether your implant has loosened. Ask your surgeon whether he or she feels you should have revision surgery—then get a second opinion from another surgeon.

While there will be class action suits filed against Stryker, you should definitely speak with an attorney before deciding to join in such a suit. Taking part in a class action suit can leave you without your medical expenses covered and you may receive no compensation for pain, suffering, or lost wages. Hopefully you have kept comprehensive records from the very beginning of your implant surgery, but even if you have not, begin now. Record any pain or other symptoms you have suffered following the implant as well as how your daily life has been impacted. Keep a record of each doctor seen and every treatment recommended.

Don’t delay treatment because you are considering a lawsuit, and continue working as long as you are able. Speak to an attorney as soon as possible to ensure you do not exceed the statute of limitations. Because the failure rate is relatively high for these recalled implants, the fact that you have not yet experienced problems related to the implant is no indication that you will not have problems in the future. Stryker is not likely to simply write you a check for your medical expenses and the trauma you have experienced. Knowledgeable attorneys understand the importance of preserving evidence and will not try to convince you to file a lawsuit unless they are convinced you have a solid case.

New Jersey Establishes Multi-County Litigation for Stryker Rejuvenate

After the recall of the Stryker ABG II and Rejuvenate hip implants in July, 2012, lawsuits began pouring in following the lead of the DePuy ASR hip implant recall. In January, 2013, a multi-county litigation was established for the suits against Stryker in the Bergen County Superior Court under Judge Brian R. Martinotti. Three months prior to the issuance of the Stryker recall, notice was sent to surgeons and hospitals regarding the potential risks involved for those with an ABG II or Rejuvenate implant. The specific risks included corrosion and fretting at the metal neck junction which could lead to microscopic metal shards burrowing into surrounding tissue or entering into the bloodstream.

Once corrosion and fretting occurs, the implant recipient can suffer inflammation, chronic pain, loss of tissue or bone, loosening of the implant or joint dislocation. Any of these serious symptoms can result in the necessity of a revision surgery to replace the defective hip implant device. Pseudo-tumors can also result from the cobalt and chromium ions and, once formed, require surgery to remove. Symptoms of metal toxicity such as cardiovascular, renal thyroid and gastrointestinal disorders, disruption of DNA, vertigo, skin problems, memory loss, anxiety and depression can all occur when cobalt and chromium have built up in the body to a certain level. Some people are more vulnerable to metals in the body than others, but there really are no safe levels of toxic metals in the body.

Stryker is expecting to pay out almost $400 million dollars in legal fees, costs for revision surgeries, blood tests, x-rays and MRIs for the 20,000 recalled hip devices implanted in recipients. Following the recall Stryker advised those patients who were having any type of trouble related to the implant to seek the advice of their physician. Even those who are not currently experiencing problems with their implant should undergo blood tests and image screening since a large percentage of the implants experienced failure within 3-5 years following the initial implant. Although 81 lawsuits have been filed against Stryker in this latest New Jersey multi-county litigation, it is expected there will be many more to come between now and the time the statute of limitations runs out. On March 19, 2013, a case-management conference regarding the multi-county litigation took place.

Stryker is one of the largest manufacturers of orthopedic devices, generating over $8 billion in annual sales in 2012, and ranking at 308 on the Fortune 500. This is due in part to the fact that when the companies who manufactured metal-on-metal hip implants began having lawsuits filed against them Stryker picked up that share of the hip implant market due to the fact that the company was offering an innovative design which included several neck and stem components which gave surgeons greater flexibility in custom fitting the implant to the specific patient. The stems were manufactured using Stryker’s titanium alloy blend which they claimed would resist the effects of corrosion and fretting.

Despite this claim, post-market data revealed evidence of corrosion and fretting, serious side effects including implant loosening and the release of toxic metals which eventually led to the recall. The hip implants which were intended to last considerably longer than ceramic or polyethylene implants began failing within the first two, three and four years following the initial implant. The first DePuy ASR lawsuit was recently settled for a staggering $8.3 million dollars; many believe this is an indication of how the thousands of hip implant lawsuits will continue to resolve, perhaps including the Stryker ABG II and Rejuvenate lawsuits as well.

Discussion of the Use of Biological Mesh for Pelvic Organ Prolapse Repair

An article in Current Urology Reports Journal published in June of 2012 detailed the use of biological grafts in the repair of pelvic organ prolapse. Specific information is presented in this article regarding the complications associated with the different prolapse compartments (posterior, middle and anterior). When the pelvic floor weakens—generally due to childbirth, surgery, menopause or aging—organs can drop from their normal position causing significant discomfort, pain and a variety of other symptoms. There may also be a genetic predisposition which contributes to the development of pelvic organ prolapse. The authors state that by the age of 80, at least 11% of all women will require POP surgery.

Unfortunately, there is also a 30% chance of recurrence which will require subsequent surgical procedures. There are other patient characteristics which can increase the risk of pelvic organ prolapse as well as surgical failure including obesity, the number of children, a history of smoking, constipation or a chronic cough and the overall state of the immune system. To improve the overall results of POP surgery both biologic and synthetic meshes are used, however synthetic meshes—while improving anatomic results—can bring complications such as mesh extrusion or erosion. Biological grafts can offer similarity to recipient tissue, decreasing the recurrence rate. 

Biologic grafts are either harvested from the patient’s own body from the vaginal lining, the rectum or the thighs, and while there is no risk of rejection or transmission of disease, operating times are extended and there can be complications at the site of the graft. Allografts are grafts which are extracted from cadaver tissue, and while an overall good choice there is some risk of disease transmission. Xenografts come primarily from cows and pigs. With both allografts and xenografts, disease screening is performed and the techniques for harvesting are fairly standard. The processing techniques can vary, however, with no clear consensus regarding the best method.

Anterior compartment prolapse tends to be the most common form of pelvic organ prolapse. Anterior prolapse occurs when the bladder and/or urethra are protruding; the use of biological tissue in the repair of this type of prolapse has shown inconclusive results. Middle compartment prolapse can involve the uterus, bowel, rectum, bladder or vaginal vault. Comparing biologic grafts to synthetic grafts in the transvaginal and abdominal repair of middle compartment prolapse has shown biologic grafts to be inferior to synthetic. Posterior compartment prolapse involves the herniation of the anterior rectal into the vagina leading to sexual dysfunction and chronic constipation. While traditional repair of posterior prolapse has shown high rates of success, painful sexual intercourse can be a typical side effect.

Regarding biological grafts in pelvic organ prolapse repairs, the most common complications included graft erosions which were less serious than the synthetic mesh erosions. The FDA issued an updated warning in 2011 regarding the use of transvaginal surgical mesh stating there was insufficient evidence to show any benefits of mesh over more traditional methods and that mesh complications were “not rare.” Better patient monitoring following surgery is recommended by the FDA as well as alterations in the pre-market application approval process.

Synthetic Mesh Materials used for Pelvic Organ Prolapse Repair

This article will summarize findings by a review article published in the June, 2012 issue of Current Urology Reports Journal which assesses outcomes and complications when synthetic mesh is used in the surgical treatment of pelvic organ prolapse as well as FDA findings on the subject. Pelvic organ prolapse occurs when the muscles and tissues which hold such organs as the bladder, uretha, uterus and vagina in place break down, allowing the organs to move downward. The location of the defect determines its classification, including anterior (cystocele), posterior (rectocele) and apical (enterocele).

Traditional pelvic organ prolapse repair known as a colporrhaphy, either folds the native tissue or anchors them to surrounding structures. 17% of the repairs which use these techniques will require further surgical procedures. Grafts are used to strengthen weak tissues, decreasing the likelihood of recurrence. Graft use also allows surgeons to repair multiple sites in the same operation. Biologic grafts can consist of autografts (tissue from the same individual) allografts (tissue from another human) or xenografts (non-human organism tissue). Limitations to biologic grafts include cost, limited availability and the risk of disease transmission. Because of these limitations, synthetic mesh used in the repair of POP was approved by the FDA in 2001.

Synthetic grafts are classified according to filament number and pore size with variations in weight and flexibility. Type 1 mesh is macroporous, monofilament polypropylene, marketed under such brand names as Marlex™, Atrium™, Prolene™, Gynemesh™ and Pelvitex™. Type 1 mesh appears to have the highest rate of success due to its larger pore size which leads to better tissue grown and lower rates of infection. Despite this success rate, these vaginal mesh kits can provoke the body’s defense cell responses, causing the formation of granulomas.

The specific surgical technique used also has bearing on the rate of success in POP repair. Whether anterior, posterior or apical, the traditional colporrhaphy procedure may be implemented or the augmented procedure can be used. Regarding anterior repairs, mesh augmentation decreased recurrence rates however showed higher rates of complications. Apical compartment repairs also showed better results when mesh augmentation was used however no significant differences were noted between colporrhaphy and mesh augmented procedures when repairing the posterior compartment.

Complications associated with synthetic mesh kits are classified by the affected area, subdivided by time of occurrence such as an immediate physician-caused injury, short-term erosion and bleeding or long-term mesh extrusion, pain or painful sexual intercourse. According to the data in this particular article, incidence of erosion and extrusion range from 5-19%. Stress incontinence as a side effect of surgery occurred less often in colporrhaphy procedures than those which used surgical mesh. Painful sexual intercourse occurred equally in both groups, with the exception of a higher rate in posterior compartment colporrhaphy repairs. One study presented in the article noted that polypropylene meshes can retract up to 66% following surgery, leading to vaginal shortening and narrowing.

The French Health Authorities stated in 2006 that more research is required regarding the use of synthetic mesh in POP repair. The FDA followed in 2008 by issuing a public health notification regarding the use of synthetic mesh in POP repair. Suggestions offered included specialized physician training as well as using mesh only after weighing other alternatives. Physicians were advised to inform patients of potential complications as well as to ensure they understand that the mesh is considered permanent. An update to the 2008 notification was issued by the FDA in 2011 which stated that complications from the use of mesh in POP repair were “not rare” and that it was unclear whether the use of mesh showed any benefit over traditional repairs. Literature in this article, however, concluded that the FDA’s view was biased and that further research was necessary to compare colporrhaphy to repair using synthetic mesh kits.