Millions of Americans have medical devices implanted in their bodies, including artificial joints, heart defibrillators and surgical mesh. Many individuals with medical devices implanted in their bodies may assume that they have been tested for safety, but that may not be true.
Most implants and high-risk medical devices are brought to market after a manufacturer has filed paperwork and paid the Food and Drug Administration a user fee of approximately $4,000. While some advanced safety studies are required for some high-risk products, the studies are not as rigorous as those for prescription drugs.
Some concerns have been expressed related to problems associated with the FDA's device regulatory system and that the regulatory system does not ensure patient safety. There is a concern that medical devices can enter the market untested and that clinical trials are essentially being run on the American public. There is currently no systematic process to become aware of problems with devices.
Some recommendations to possibly improve the safety of medical devices for consumers include requiring that implants are tested as rigorously as drugs; end grandfathering of high-risk implants and other devices; create a system to identify implants so patients can be alerted to recalls and safety concerns; create national registries so that problems are quickly identified and patients quickly notified; and increase user fees paid by manufacturers to help fund the FDA's oversight.
In addition, patients can sometimes consider not getting an implant and asking about alternatives or what happens if they do not get the implant. But, when a patient has been injured by an implant or other medical device, there may be legal options and remedies available to them which is why it is important that they research and ask questions.