In an attempt to protect consumers from the dangers of defective medical devices, the U.S. Senate recently proposed draft legislation that would require manufacturers to conduct ongoing safety studies of medical devices even after the device has obtained the approval of the U.S. Food and Drug Administration (FDA). The legislation was drafted, in part, as a response to the increasing number of lawsuits that have been filed against the manufacturers of defective medical devices, particularly vaginal mesh implants.
Currently, the FDA permits certain medical devices to be approved under its 510(k) system, which requires only that manufacturers demonstrate that their product is substantially similar to one already on the market. The Senate pointed to the 2010 recall of the DePuy ASR hip implant system, which was approved under 510(k) procedures, as evidence that the current guidelines are ineffective in protecting the public from dangerous and defective medical devices.
With respect to the specific dangers associated with transvaginal mesh implants, the FDA has also requested that manufacturers of vaginal mesh implants, such as Bard and Johnson & Johnson, provide additional information regarding the companies’ safety inspections and recall procedures.
Since 2008, the FDA has warned consumers and health practitioners since 2008 about serious complications associated with vaginal mesh implants that are used to treat pelvic organ prolapse and stress urinary incontinence. According to the FDA, more than 1,000 reports from nine surgical mesh manufacturers, including American Medical Systems, Bard, Boston Scientific, Caldera, Ethicon, Gynecare, Johnson and Johnson, Mentor and Sofradim, have been filed with the FDA’s adverse events reporting database. The American of Obstetricians and Gynecologists and the American Urogynecologic Society issued a joint statement last November recommending that the use of transvaginal mesh be limited. Although the FDA is continuing its safety review of vaginal mesh implants, there are currently no plans to issue a recall of these products.
Hundreds of lawsuits have been filed against the manufactures of transvaginal mesh implants, as well. C.R. Bard and Johnson & Johnson face hundreds of lawsuits from women claiming that their transvaginal mesh implants caused scarring, pain, bleeding, blood vessel damage and other complications.
If you have been injured by a medical device, such as transvaginal mesh or a hip replacement system, you may wish to consult with an experienced product liability attorney. At Ankin Law Offices, LLC, our knowledgeable Chicago product liability attorneys focus on protecting the victims of dangerous and defective products, including defective medical devices. Contact our offices at (312) 346-8780 to schedule a free consultation with one of our skilled Chicago medical device attorneys to learn more about your legal rights.
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