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Transvaginal Mesh: FDA Wants Manufacturers to Conduct Three-Year Studies on Complications

The Food and Drug Administration has written to 33 medical device manufacturers directing them to conduct three-year study into the health complications that may arise from using transvaginal mesh. Between just 2008 and 2010, the federal agency received 1503 reports of adverse occurrences, which is fivefold greater than the two previous years.

Hundreds of women have come forward to file products liability lawsuits over their vaginal mesh implant-related injuries claiming. In Massachusetts, if you are someone who believes that your health complications are a result of your transvaginal mesh procedure, contact our Boston defective medical device law firm immediately.

A medical device of choice for treating stress urinary incontinence and pelvic organ prolapse, transvaginal mesh has been linked to organ damage, chronic pain, urinary tract infection, perineal cellulitis, infection, organ perforation, painful intercourse, and even death. Also, last year the FDA reported it couldn’t confirm that vaginal mesh provided any added benefits compared to other procedures and devices used to treat the same health issues.

Boston Scientific, Johnson & Johnson, and CR Bard Inc. are three of the 33 medical device makers who received letters from the FDA calling for the studies. The federal agency wants the manufacturers to study vaginal mesh devices that are currently available for use. (Transvaginal mesh products that aren’t in the market yet don’t have to be included in the study.)

Because vaginal mesh products get their FDA approval through the 510(k) system, they don’t have to be tested on humans first because they are already similar to a medical device that was already approved. It is important to note, however, that the Boston Scientific vaginal mesh device that was FDA approved was recalled over a decade ago.

Transvaginal Mesh
This kind of mesh is a surgical mesh (usually made from polypropylene or polyester). It is often used as a bladder or pelvic sling, to strengthen the vaginal wall and/or provide support to organs that have been displaced. Unfortunately, when health complications arise as a result of transvaginal mesh, the patient may have to undergo additional surgeries and more complications can arise.

J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA Says, Bloomberg, January 5, 2012

Looking Into Problems With Transvaginal Surgical Mesh, FDA

More Blog Posts:
Vaginal Mesh Injuries Lead to Boston Defective Medical Device Lawsuits, Boston Injury Lawyer Blog, September 22, 2011
Boston Products Liability?: FDA Considering Tougher Review Process for Mesh Products, Boston Injury Lawyer Blog, August 30, 2011
Defective Medical Device?: Transvaginal Mesh to Treat Pelvic Organ Prolapse May Cause Health Complications, Warns FDA, Boston Injury Lawyer Blog, July 15, 2011
At Altman & Altman, LLP one of our Boston injury lawyers would be happy to provide you with a free consultation to determine whether you have a Massachusetts transvaginal mesh lawsuit on your hands.