Category: Medical Device Law

Joint Commission Makes Recommendations On Use Of Transvaginal Mesh

A recent report issued jointly by the American College of Obstetricians and the American Urogynecologic Society details vaginal mesh recommendations, including that the mesh should only be used for certain high-risk women. The safety and efficacy of the synthetic mesh, also known as transvaginal mesh or bladder mesh, has been called in question, making its… read more

Transvaginal Mesh Device Based On Recalled Product

As women across the country continue to suffer complications from the use of Johnson & Johnson’s transvaginal mesh devices, a new report reveals that the design of the bladder mesh was based on recalled transvaginal mesh devices that had been taken off the market more than ten years ago due to safety problems. The devices… read more

Transvaginal Mesh Linked To Serious Side Effects And Complications

The FDA has recently issued an updated transvaginal mesh warning on the use of the mesh to help repair pelvic organ prolapse (POP). POP occurs when the pelvic organs fall out of place as the result of the stretching or weakening of the tissues holding the organs in place. Transvaginal mesh – also known as… read more

FDA Holds Hearings On Transvaginal Mesh

The FDA met last week to determine whether surgical mesh inserted surgically inserted into the vagina, also known as transvaginal mesh or pelvic mesh, needs tighter regulation by the FDA. The mesh is used to treat a painful condition called pelvic-organ prolapse. As the result of close to 3000 reports of adverse events, including seven… read more

FDA Warns Of Risks Associated With Transvaginal Mesh

Recently the FDA issued a transvaginal mesh warning concerning the use of the medical device (also known as pelvic mesh, pelvic sling, or bladder mesh) as a method to repair pelvic organ prolapse. The FDA warning stated that using transvaginal mesh to repair pelvic organ prolapse exposes patients to an “unnecessary risk” without providing any… read more

DePuy Hip Linked To Metal Poisoning

More and more claims concerning the troubled DePuy Hip continue to emerge. A recent article reveals that in addition to extreme pain from the faulty medical device, other symptoms related to metal poisoning occurred. According to one DePuy Hip patient – Tony Stauffer – discussed in the San Diego news, his hair started to fall… read more

DePuy Hip Recall Makes Some Experts Question FDA Medical Device Review Process

A recently released medical device study concludes that the FDA should “abandon” its present system for approving U.S. medical devices such as the DePuy Hip because it fails to ensure patient safety. Currently, the FDA employs a streamlined approach to approve medical device applications such as those for the beleaguered DePuy knee and hip parts… read more

Senate To Begin Investigation Of DePuy Hip Safety

This week the U.S Senate will begin its probe into medical device recalls and the connection between the massive DePuy Hip Replacement recall and the FDA’s role in “protecting patient safety as part of the medical device approval process.” The DePuy Hip was recalled after numerous reports of metal shards breaking off the hip replacement… read more

Zimmer NexGen Knee Recall Urged Due To Component Problems

Several physicians are urging a Zimmer NexGen Knee recall as the result of serious problems and component failures in the knee, requiring additional surgeries. The FDA has recalled some of the components following several lawsuits concerning the Zimmer NexGen CR-Flex knee failure rate. In fact, a prominent consultant for Zimmer recently went public stating that… read more

Product Liability Claims Arising Out Of DePuy Hip Replacements

As reported in the Wall Street Journal – as the result of a loophole in the Food and Drug Administration’s regulation of medical implants – many potentially faulty hip implants are on the market. New drugs must undergo clinical trials before receiving FDA approval, however, if a medical implant resembles a product already on the… read more