Before a medical device or implant is approved, it typically undergoes testing by the U.S. Food and Drug Association (FDA).
The FDA is supposed to examine each medical device for safety and efficacy. In reality, they’re unable to screen every single device and surgical tool.
At times, implant manufacturers push the FDA to approve a medical implant before the implant has been adequately and thoroughly tested. They do this for a variety of reasons:
- Some patients need the device to survive, and they want to supply it as quickly as possible.
- The manufacturers are profit-driven and want to make money on the sale.
In recent years, the approval process for medical devices has been accelerated more so than before, and manufacturers tend to push for faster device approval and less rigorous testing. Frequently, the FDA approves a new device, prosthesis, or implant from its “substantial similarity” to an already existing device. But in some cases, they’re not equivalents at all. Would you trust the same material on a metal hip to be used for a non-metal knee implant?
Numerous medical devices, like metal hip replacements and hernia mesh implants, are now discovered to be flawed—leading to painful injuries and internal damage.
- Metal hip replacements involve the placement of medical implants in the socket of the hip and at the end of the femur (the thigh bone). Traditionally, hip implants involved a metal ball and stem placed at the end of the femur and a polypropylene (durable plastic) cup at the end of the pelvis. Some hip manufacturers switched the design to have both the replacement ball and the receiving cup made of metal. The metal-on-metal design proved to be defective, leading to complications like fractured or broken implants, high levels of metal in the blood, implant corrosion, swelling and pain, infection, cobalt and chromium poisoning, and bone fractures.
- Hernia mesh implants have been around for almost 50 years, but devices manufactured by C.R. Bard and Ethicon are allegedly defective and dangerous. Adverse reactions like infections, hernia recurrence, bowel obstruction, holes forming in neighboring tissues or organs, as well as additional surgery have resulted.
If you or a loved one has been injured by a defective or recalled drug or a medical implant, you may be entitled to compensation from those responsible for your injury. If a loved one has died, the surviving spouse or other family members may be entitled to bring a wrongful death action against the responsible parties.
Damages can include past and future medical expenses, loss of past and future earnings, pain and suffering, emotional distress, and even punitive damages awarded to punish the responsible parties.
Foley & Small is now accepting and litigating cases on behalf of clients who have suffered injuries as a result of medical implants. To learn more, call 574-288-7676, or visit them online at www.foleyandsmall.com.