As a medical device lawyer for more than 20 years, I have received so many calls from patients who are concerned that they have a recalled hip implant in their body. Often, their first notice of a potential problem with their hip replacement device is when they hear something on TV, often a lawyer advertisement, that mentions a recall or safety concerns over a particular hip implant model. In addition to having concerns about their health due to having a potentially defective device in their body, many of these patients are also angry that their surgeon or the medical device manufacturer did not notify them directly of potential safety issues, ask them to return to the office for closer monitoring for potential problems, offer financial assistance for follow up evaluations, etc.
So, perhaps the best place to start is with a question. Who has an obligation to notify patients of potential safety issues with a hip implant? The answer, unfortunately, is perhaps no one, especially for a device not yet formally recalled.
Why Aren’t Patients Tracked?
Sadly, in the United States, we do not have formal joint registry tracking the performance of hip implants placed in patients. These joint registries are common in other countries and provide some of the best data on patient outcomes, comparison of performance of various manufacturer’s models, implant life-expectancy well-performing as well as poor-performing hip implants. In fact, many of the safety signals and scientific evidence that led to hip implant recalls or widespread defective product lawsuits in the United States emanated from national joint registries and hip implant safety surveillance in Australia and the United Kingdom.
For example, the DePuy ASR hip implant was recalled in the United States in August of 2010 only after there was an uptick noted in the foreign registries for patients undergoing revision surgeries within several years of implantation of this metal-on-metal hip implant product due to the presence of elevated levels of cobalt and chromium, metallosis, osteolysis, soft tissue and bone necrosis, and pseudotumor formation. The American Academy of Orthopaedic Surgeons (AAOS) started a national registry program in 2011 which now includes more than 30,000 patients, which is a step in the right direction but far short of what patients in the United States deserve.
For years, the medical device industry has fought the implementation of a national registry in the United States, arguing that the implementation of such a system would be very costly. Yes, there is a cost associated with maintaining a national device registry (or at least a registry maintained by the implant manufacturer), but this cost is not too much for other manufacturers, such as the automotive industry, that can easily send out recall notices by tracking VIN numbers on the vehicles that it sells.
Solutions From Other Industries
It is sad that more thought and resources are put into alerting consumers of a defective wiper blade than in informing patients of the need for prompt medical evaluations due to their implantation with a dangerous medical device. The hip implant manufacturers also argue that a national database with hip implant details is only possible in other countries due to universal healthcare or socialized medicine. The other reality is that a national database would allow surgeons and patients to compare the performance of similar hip implant models marketed by the hip implant manufacturers, and that is something that is frightening to the manufacturers as they would prefer to conduct and publish their own, tightly-controlled studies that would have a direct impact on their marketing and sales performance.
Some manufacturers do attempt to keep a record of patient implant information so that they technically have the ability to notify patients when there are problems, but other device manufacturers make the conscious decision to keep no records that would enable them to contact patients if there was a problem with one of their medical devices (and are within their legal rights to do so).
If there is a recall of a product or a serious safety issue that the hip implant manufacturer has publicly conceded, then that information is generally passed to the orthopedic surgeons through direct communication from the medical device manufacturer. Most surgeons will then share that important safety information with their patients, but only those who are visiting the office for follow up visits or those who are seeking medical evaluations for problems associated with the implants. The biggest challenge with hip implant patients is that most stop seeing their orthopedic surgeon not long after the initial surgery, even though they should be following up on an annual basis (especially in light of the number of modular and metal-on-metal hip implants that have been the subject of recalls or safety issues over the past 5 to 10 years).
Surgeons Can’t Do It All
Very few surgeons will proactively reach out to patients with whom they are no longer treating to alert them to a recalled hip, and it is likely that the surgeon does not have a master record of all of the devices implanted (such that individual patient charts would need to be pulled and reviewed in hopes of identifying the hip implants placed in the patients). Further, there are often safety concerns with a hip implant that does not lead to a formal FDA recall of the device, and those patients are unlikely to obtain information from the manufacturer (who denies that there is a problem with the product).
When the Stryker ABGII and Rejuvenate modular hip implants were recalled in July of 2012, many patients received direct communication from their orthopedic surgeons about the recall as well as the Broadspire program to reimburse out-of-pocket expenses to surgeons and patients for evaluations and revision surgeries required to remove the femoral stem of the hip implant which was prone to corrosion and galvanization.
Since the failure of the recalled Stryker Rejuvenate and ABGII hip implant occurred within months or only a few years of implantation, many of the patients were still seeing their surgeons on a regular basis, such that notification was possible. Unfortunately, some surgeons, however, chose for whatever reason not to proactively notify their patients that they had been implanted with a recalled Stryker hip implant. Many of those patients may have suffered more bone and tissue damage as a result of the delay in removing the corroded femoral stem.
Tips If You’re Concerned About A Recalled Hip Implant
Here are some tips for patients who are concerned that they have been implanted with a failed, defective, or recalled hip implant:
Return to see your orthopedic surgeon on an annual basis and notify your surgeon of any changes in your contact information. Ask your surgeon for details about the hip implant that was implanted into your body and follow up annually to see if additional information has been discovered relating to the performance of the device or any safety issues.
Request a copy of the operative report for your original surgery including the product identification stickers. Unfortunately, many surgeons do not have the stickers in their patient chart, but they should be included in the hospital chart. Often the stickers are peeled off of the boxes that include the hip implant components during the surgery and attached to the handwritten notes kept during the surgery by a member of surgical team, usually the scrub nurse. When we request medical records from a hospital in an effort to obtain product identification information, we specifically request an abstract from the hospital that includes the operative report as well as the product identification stickers. Some hospitals are now keeping electronic records for all of their surgical procedures and will discard the stickers but type in the brand name, model number, lot number, and other pertinent information from the stickers into the electronic surgical notes.
Set up a Google alert for the type of hip implant that you received with at least the name of the manufacturer and model number, so that you can be notified via email if there is anything published on the internet with regard to your particular device. Although patients generally believe that all devices that are the subject of lawsuits are recalled devices, that is rarely the case, so avoid using the word “recall” in your alerts, as you may miss out on important safety information. It is unlikely that a recall notice is going to list the lot number for a particular recalled device either, so avoid including those in your alert request.
If a device is recalled, there will be safety information published on the manufacturer’s web site as well as the FDA web site. Generally, these sites have a search function that will allow you to easily locate important safety information about a particular device. Unfortunately, however, manufacturers may issue a “field safety notice” or “hazard alert” directly to physicians for safety issues that they contend do not rise to the level of a formal recall, and these notices are often not readily available online or provided to patients.
Be wary of lawyer web sites. There are lots of them out there. Some provide good information to patients about potential risks, while others are focused on attracting new clients. That being said, when there is a potential safety issue with a medical device, these sites may include more information than any other source.
The FDA has a web site (www.fda.gov) with lots of information about pharmaceuticals, medical devices, and other types of products. It is searchable and will include warning labels, patient information materials, some adverse event reports, and recall notices.