Metal-on-metal hip replacements have experienced an unusually high failure rate, as high as 43% for one model. Several models have been subject to voluntary recalls, and Great Britain’s National Health Service recently announced a ban.
Metal-on-metal hip replacements were introduced under a belief that they would be more durable than other types of implants. However, metal debris—usually chromium or cobalt—can be released into the patient’s body as the implant’s ball and socket rub against each other. This can lead to reactions such as inflammation, groin pain, dead tissue, and bone loss, and often forces patients to have a procedure to replace the implant, known as revision surgery.
The US, UK, Australia and Canada have each issued health warnings related to the failure of metal-on-metal hip replacements.
The FDA does not require clinical trials for orthopedic implants if the device is similar to one already on the market. This ostensibly allows companies to make incremental changes to their devices without resubmitting them for approval. In the case of DePuy’s ASR (Articular Surface Replacement) XL Acetabular implant, that process allowed an unapproved joint design to be incorporated into a hip replacement and the device released to the market without clinical testing.
A 2013 article in the New England Journal of Medicine neatly illustrates the flaws in the 510(k) approval system by tracing the ancestry of the ASR XL Acetabular hip system.
There were numerous problems with the implant’s approval process:
In January of 2013, the FDA proposed changes to existing rules that would require approval of new metal-on-metal hip replacements prior to their release.
In late 2009, DePuy, a division of Johnson & Johnson, began to remove its ASR implants from the shelves, citing flagging sales. Then, in August 2010, the company issued a recall due to the device’s high failure rate, approximately 12% after 5 years according to a study of UK patient registries. A further study, released in 2013 by the UK’s National Institute for Health and Care Excellence (Nice), found that the failure rate of the DePuy implants reached 43% after 9 years.
DePuy had been receiving complaints about the devices from physicians and patients for years before the recall, which it generally blamed on surgical error.
In October 2013, based on the Nice study, Great Britain’s National Health Service drafted new rules to ban the use of all hip implants with a failure rate above 5%. The ban will affect virtually every model of metal-on-metal hip implant currently on the market.
Other hip-replacement manufacturers in the United States have issued voluntary recalls.
In 2012, Smith & Nephew recalled the metal liners in its R3 Acetabular System, citing high failure rates based on evidence from the UK and Australia. Also in 2012, Stryker recalled its Rejuvenate and ABG II modular-neck hip stems due to high rates of corrosion and the possibility of tissue damage and inflammation.
When a company recalls a hip implant, it generally issues a letter, to physicians, to insurance companies, or directly to patients. The FDA also maintains a searchable database of recalled medical devices and announces device recalls when they happen. Recall letters will often suggest a course of action and explain how a company will compensate individuals (e.g. through paying for revision surgery).
If your hip implant is recalled, speak to your doctor immediately to help decide on the best course of action. As you make your decision, it’s important to keep in mind that device manufacturers may structure recalls in such a way as to limit their legal liability, or ask patients to waive their right to privacy or to a lawsuit. A recall may require that a patient takes a specific course of action in order to receive compensation, thus limiting treatment options.
DePuy in particular has been criticised for its handling of the ASR recall, for which it uses a third party, Broadspire Services Inc. (Stryker also employs Broadspire.) Critics have accused DePuy of trying to take advantage of patients who don’t fully understand their legal rights. Broadspire has also asked patients to pay for revision surgery out of pocket before considering reimbursement claims.
The terms of a recall may very well be right for you. Before agreeing to anything, however, consult your lawyer to make certain your legal rights are protected.
If you’ve been affected by a hip replacement, we can help. Enter your information to be contacted about a free case review.