Four Democratic U.S. Representatives have introduced legislation designed to close a major loophole in the process by which the federal Food and Drug Administration approves medical devices. The legislation’s sponsors specifically cite vaginal mesh implants and metal-on-metal hip implants as dangerous and defective devices that have made it onto the market as a result of that loophole.
A news release from the bill’s main sponsor, U.S. Rep. Edward Markey of Massachusetts, states that thousands of patients have suffered grave health effects from faulty medical devices that the FDA cleared only because they were considered similar to other devices – even if the original devices were recalled for major safety problems.
The Safety of Untested and New Devices Act of 2012 (SOUND Devices Act) is now before the House Committee on Energy and Commerce.
“If an automobile is recalled for a major safety problem, we wouldn’t allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies,” said Rep. Markey. “The SOUND Devices Act is based on the common sense principle that patients should not be put at risk by devices that are allowed to be sold only by proving their similarity to a defective product. The SOUND Devices Act closes a significant loophole that currently puts patients at serious risk of debilitating injury by ensuring that devices do not mimic the mistakes made by other products.”
The SOUND Devices Act:
- Provides FDA the ability to reject a device application based on a predicate that has been recalled or is in the process of being removed from the market for major safety problems;
- Requires companies to inform FDA if any products in their new device’s “predicate lineage” have caused serious harm and to explain how theirs avoids past mistakes;
- Instructs FDA to maintain a publicly accessibly database that companies can use to determine whether a device can be used as a predicate;
- Strengthens reporting requirements so that companies and the public can easily determine why a recall occurred (information that is often missing in the case of voluntary recalls);
- Calls for FDA to review the safety of high-risk devices if a product in their “predicate lineage” is recalled due to major safety problems.
If you received a DePuy Orthopaedics hip implant and are experiencing side-effects, contact Lopez McHugh for a free case evaluation.
The most common complications from transvaginal mesh implant are vaginal mesh erosion (also known as exposure, extrusion or protrusion), pain, infection, urinary problems, bleeding, and organ perforation. Also reported were recurrence of prolapse, muscular problems, vaginal scarring and mesh contraction, which causes a host of problems. Numerous lawsuits have been filed over these complications, in part because studies show no benefits over non-mesh repair.
If you had a mesh implant and suffered one of the above symptoms, contact us to discuss your options for pursuing compensation, or have your questions answered by a qualified attorney, with no obligation.
See more about the SOUND Devices Act here: http://markey.house.gov/press-release/markey-waxman-schakowsky-delauro-introduce-legislation-close-loophole-flawed-medical