Shannon and Daniel Farr have filed a Boston Scientific mesh lawsuit in the Northern District of Alabama. Mrs. Darr was implanted with a Boston Scientific Pinnacle Posterior Pelvic Floor Repair Kit, and claims she suffered complications including infection, tissue damage, and an adverse reaction to the mesh itself. She adds that some of these injuries are permanent.
This Boston Scientific Pinnacle mesh lawsuit is one of many recently filed by women who have suffered severe and debilitating injuries. A recent FDA warning about the serious complications associated with vaginal mesh has increased awareness about the issue, giving more women reason to come forward.
California Women File a Boston Scientific Mesh Lawsuit
Dozens of women filed a Boston Scientific mesh lawsuit in California in 2010, claiming they endured painful complications after the mesh was implanted. Many of these cases have now been transferred to courts across the country. Boston Scientific says they’re looking into the issue with the FDA, but has not admitted any fault with their devices.
FDA Warning Adds Clout to Boston Scientific Mesh Complications Lawsuit
In July 2011, the FDA issued a serious warning about vaginal mesh, stating that complications with the surgical material were not rare, and that surgery with the mesh may be no more effective than traditional surgery without it. The agency also warned doctors to tell their patients that some complications may require additional surgeries, and that these surgeries may or may not fix the problem.
Women who have filed a Boston Scientific mesh complications lawsuit claim that the mesh itself is defective. Cells in the body grow around it after implantation—which is intended—but the mesh has been reported to cause infections, erosion, and pain, and when surgeons try to remove it, it’s nearly impossible to get it all out. As a result, many women have experienced lasting damage.
FDA Subcommittee Recommends More Clinical Studies
Following the FDA warning in July, the agency convened a subcommittee meeting to further investigate the safety issues. After two days of reviewing the data and hearing opposing sides of the issue, the Obstetrics & Gynecology Devices Panel recommended that more clinical studies be performed on the mesh products currently on the market, and that future mesh products be required to prove safety through clinical studies before gaining FDA approval.
In response to the panel’s recommendations, President of the Company’s Urology and Women’s Health Devision John Pedersen stated, “Boston Scientific believes that mesh products are a valuable option for surgeons who treat women with pelvic floor disorders and stress urinary incontinence and that these products offer a safe and effective alternative to non-mesh treatment options.”
In August 2011, Boston Scientific issued a class 2 recall for their Pinnacle Pelvic Floor Repair Kits, due to problems with the needle used in surgery. The company so far, however, maintains that its vaginal mesh products are safe.
You May be Eligible for a Boston Scientific Mesh Lawsuit
If you or a loved one has experienced an injury as a result of Boston Scientific mesh, you may be eligible for compensation in a Boston Scientific mesh lawsuit. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.
