Original Form of Transvaginal Surgical Mesh Recalled Many Years Ago
The assumption is always the same – the U.S. Food and Drug Administration (FDA) checks drugs and medical devices for safety before it allows anything to be marketed, right? Not exactly. Thanks to a loophole within the agency, medical devices that are considered of moderate risk (Class II) do not have to have any premarket review, clinical trials, safety tests, and efficacy. They are generally assumed to be safe if they name a “predicate” device, one that’s already on the market.
In the case of modern synthetic or plastic surgical mesh used to treat incontinence and pelvic organ prolapsed (POP) in women, the Boston Scientific mesh called ProteGen is named as a predicate. However, ProteGen was pulled from the market a dozen years ago because of safety concerns and the FDA does not require a re-review of the mesh that followed.
Bloomberg reports that this is just the latest revelation that questions whether polypropylene mesh should ever have been approved to be marketed under the FDA’s 510(k) process.
Hundreds of lawsuits have been filed against nine mesh manufacturers, Boston Scientific, American Medical Systems and Johnson & Johnson among them. The product liability actions claim the mesh is defective and has lead to thousands of transvaginal mesh side effects including intense pain, disability, bleed outs, nerve damage, mesh erosion, and the perforation of organs. Seven deaths have been recorded.
In July, the FDA issued a warning to medical doctors and women that the benefits of mesh likely do not outweigh the risks and that consumers should seek solutions other than mesh for prolapse and incontinence problems. The FDA based its assessment on its own data, collected on its adverse event database MAUDE. But filing a report is difficult at best and many women don’t know their model number. Even with the difficulty of filing a report, there are thousands that the FDA knows about and likely thousands that the agency doesn’t.
The Florida transvaginal mesh injury attorneys at Farah & Farah are taking calls from women who have been implanted with surgical mesh and now believe they too may be experiencing a problem. A call to our product liability team will get us started looking into your case. Remember, the clock is ticking and there is a limited time within which to file an action, otherwise your opportunity will be gone. Call us at (800) 533-3555.
Source: http://www.bloomberg.com/news/2011-10-20/j-j-vaginal-mesh-approved-by-fda-based-on-older-recalled-device.html
