Defective Medical Device?: Transvaginal Mesh to Treat Pelvic Organ Prolapse May Cause Health Complications, Warns FDA

The Food and Drug Administration has issued an urgent public notice warning health care providers and patients against using transvaginal mesh. This medical device is surgically implanted in women suffering from Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). Now, however, following reports of 3 deaths and 3800 injuries linked to the surgical mesh in the last five years, the FDA is encouraging the use of other treatments and alternatives.

Our Boston injury lawyers represent victims with Massachusetts defective medical device claims against manufacturers whose products proved defective or dangerous enough to cause serious injury or death. Patients rely on medical devices to do their job, whether it is support sagging organs, keep one’s heart rate at the right pace, or relieve obstructions in the body. When a device fails, serious health complications and even death can result.

Transvaginal Mesh
Last year, about 75,000 women were implanted with the vaginal mesh to repair their POP. However, according to recent studies, approximately 10% of woman inserted with transvaginal mesh experience the device’s erosion within a year of the surgery. More than 50% of women who experience this complication had to undergo another surgery to take the mesh out. In rare occurrences, the mesh has gotten so enmeshed with scar tissue that it couldn’t be taken out. Other possible side effects may include discomfort, painful sexual intercourse, urinary problems, and bleeding.

The FDA will be putting a team together to determine whether the mesh should be banned.

In a recent out of state vaginal mesh lawsuit, one woman is suing American Medical Systems and other manufacturers for products liability. Laura Jones says not only did she experience serious pain and urinary issues after the vaginal sling was inserted in her, but she had to undergo several surgeries before the mesh could be removed. She is alleging breach of warranty, strict liability, fraud, and negligence.

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, US Food and Drug Administration, July 13, 2011
FDA warns against surgical mesh to repair pelvic problems,, July 13, 2011

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Boston Products Liability Lawsuits Filed Over DePuy ASR Hip Devices, Boston Injury Lawyer, January 4, 2011
Boston Medical Malpractice?: CT Brain Perfusion Scans Can Cause Radiation Overdose, Boston Injury Lawyer, July 31 2010
Contact our Boston vaginal mesh law firm today.

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