House Members Seek Hearing on Metal Hip Implants
Certain members of the U.S. House Committee on Energy and Commerce want to hold hearings about the medical devices behind adverse reports such as those that have lead consumers who have experienced Zimmer hip problems.
Congress echoes Zimmer hip lawsuit allegations
The committee members have asked for approval to hold hearings to determine why certain brain stents and metal-on-metal hip replacement systems have been put on the market with little oversight. Though the metal hip implants in question differ in make and distribution, they are known to cause similar problems, including Zimmer hip problems like component loosening that have led some to seek Zimmer hip settlements through the means of a Zimmer hip lawsuit.
Zimmer Inc. is one such metal-on-metal hip replacement manufacturer. Though Zimmer, Inc. temporarily suspended the sales of one of its metal-on-metal hip replacement systems — the Zimmer Durom Cup — a Zimmer hip recall has not been issued. Zimmer hip problems that plaintiffs in a Zimmer hip lawsuit have allegedly experienced include premature device dislocation, soft tissue damage, bone fracture, metal poisoning, and hip revision surgery to remove and replace the implant.
Though the committee is concerned about the Zimmer hip problems that have led plaintiffs to hire a Zimmer hip lawyer to file a Zimmer hip lawsuit, it is more interested in discovering how these allegedly harmful devices were initially approved for use. The issue of the FDA’s device clearance regulations is being addressed as the committee prepares to reauthorize the medical device user fee program.
Did lax FDA regulations allow Zimmer hip problems?
Following reports such as those of Zimmer hip problems, the committee has expressed concerns with the FDA’s 510(k) clearance process. Often criticized in the plaintiff complaints in a Zimmer hip lawsuit, this clearance process stipulates that medical device manufacturers must show that their product is “substantially equivalent” to other products on the market if they want FDA clearance. This process does not require those companies to run clinical studies testing the safety of the devices before putting them on the market.
According to the claims of plaintiffs who allege Zimmer hip problems in a Zimmer hip lawsuit, medical devices cleared under 510(k) tend to have higher failure rates than other devices. Since January 2011, the FDA has received 5,000 complaints regarding metal-on-metal hip implants.
Regulatory changes may impact reports of Zimmer hip problems
The committee’s actions regarding the reauthorization of the medial device user fee program could impact each pending Zimmer hip lawsuit, and possibly the eventual amount of Zimmer hip settlements, particularly if the 510(k) clearance process is changed. Enhancing existing regulations could also lead to voluntary recalls such as occurred with DePuy’s ASR metal-on-metal hip replacement device in 2010 if, hypothetically, the number of patients reporting problems with similar devices increases.