2 FDA Orders Proposed for Surgical Mesh Used for POP

Update to post below: Our vaginal mesh lawsuits have settled and we are no longer able to take these cases. If you have any questions regarding the settlement, please call 1-888-377-8900 (toll free) to talk to an attorney.

The FDA issued two proposed orders this week to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). The orders would reclassify these products as high-risk devices. This means manufacturers would have to submit a premarket approval applications, which will then require the FDA to evaluate the products for safety and effectiveness.

Women Sue for Injuries from Surgical Mesh

POP happens when pelvic organs (bladder, uterus, bowels) bulge (prolapse) into the vagina. Our clients had surgery to repair POP and had surgical mesh implanted to hold up the bulging organs. But the surgical mesh mesh migrated into one or more organs, causing severe pain. It is almost impossible to surgically remove embedded mesh. Some of her patients have had several surgeries.

We have filed lawsuits against manufacturers of these products. Companies that make these products include C.R. Bard, American Medical Systems (AMS), Boston Scientific and Johnson & Johnson (J&J) subsidiary Ethicon.

You can click here now to contact us for a free case review or call 1-888-377-8900 (toll free).

FDA Proposed Orders

The FDA has been slow about addressing the risk of injury with surgical mesh products. In a press release, the FDA acknowledged that it has “identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse.”

Surgical mesh is a “medical device” under federal law. It is used to provide additional support when repairing weakened or damaged tissue. The FDA will be looking at the mesh product itself and any instruments included in mesh kits. These instruments, which come with many of the mesh products, are used by the surgeon to help insert, place, fix and/or anchor the mesh in the body.

The FDA will take comments on the proposed order for 90 days.

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Category: Product Liability
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