The Food and Drug Administration is proposing new regulations to stop manufacturers of hip implants from selling defective devices.
An estimated 500,000 patients received an artificial hip implant that is failing early in the United States. Under the new proposal, manufacturers will have to prove that the all-metal hip implants are safe and effective before selling. Currently, manufacturers are not required to conduct clinical studies on the implants, but just show that device resembles ones already on the market.
Hip implants used to be made of other materials such as plastic and metal, and lasted about 15 years before wearing out. However, high rates of implants are failing right after implantation, and thousands of patients will have to undergo operations to replace the devices. The implants are also causing severe tissue and bone damage, leaving hundreds of patients disabled.
Officials believe it will take a year for the rules to be finalized, after which manufacturers will have 90 days to submit clinical data to support a device's safety and effectiveness. This new rule hopes to close a loophole in the 1976 federal law that kept devices such as hip implants, which are considered less risky than other medical devices such as hear defibrillators, without much regulation.
In the past weeks, thousands of patient lawsuits have surfaced involving the Articular Surface Replacement implant sold by the DePuy division of Johnson & Johnson. Lawyers believe it will cost Johnson & Johnson billions of dollars to resolve the litigation.
The FDA may approve a drug or device it believes to be safe, only to add warnings of potential serious side effects or completely recall the drug or device at a later time. Despite this oversight, many people are seriously injured and even killed by dangerous medical devices and defective drugs each year.