The FDA acknowledges the following risks associated with Metal-on-Metal (MoM) hip implants
Hip Implants (all metal)
The Pinnacle metal-on-metal (MoM) hip system implants were created, brought to market and sold to be more durable than other materials such as ceramic or polyethylene. The intended advantage of a hip implant made of a more durable material is that the life of the replacement will last longer and prevent having to get another replacement down the road. All-metal hip implants were designed to last up to 15 years. In MoM hip implants the metal ball and the metal cup slide against each other during walking or running which can cause the release of metal particles. Metal can be released from other parts of the implant where two implant components connect. The sliding metal surfaces will cause some tiny metal particles to wear off the device into the space around the implant. Wear and corrosion at the connection between the metal ball and taper of the stem may also occur. Some of the metal ions, cobalt and chromium from the metal implant or from the metal particles will enter the bloodstream. Orthopedic surgeons take several precautions before and during hip replacement surgery to try to optimize the way in which the ball and socket rub against each other so that fewer particles are produced. However, there is no way to fully avoid the production of metal ions and some metal particles. Over time damage can occur to bone and tissue surrounding the implant and joint. Soft tissue damage may lead to pain, implant loosening, device failure, and the need for revision surgery where the old device is removed and replaced with another.
Several joint manufacturers have recalled MoM hip implants during the past decade. There are several reasons for recalls:
- Products labeling issues
- Manufacturing issues
- Packaging issues
- Design flaws
- Early implant failure
- Migration issues
- Instruction problems
- Missing components
- Fractured implants or surgery tools
Of interest, the FDA rarely initiates device recalls. The FDA relies on manufacturers to monitor the safety of their devices and to report any problems after a device hits the market. Critics complain that this type of lax regulation gives manufacturers little incentive to make safety a priority. Device manufacturers know they have a legal obligation to design, manufacture, and test their products properly. They also need to warn the public if a device fails, has adverse side effects or doesn’t do what it claims. Along with the recalls, companies will try to defend their positions in court by the finger-pointing blame game of accusing the surgeons of not implanting the device properly.
People harmed by these devices allege that the companies who recalled the products knew their designs were faulty or failed to warn patients of the risks of the implant. Companies often reach out to patients to participate in their “recall program” offering to compensate for medical claims and some damages. Patients are not aware that they may forfeit a legal case against a company later by partaking in what may seem like a responsible effort to right a wrong by the company.