Jury verdict in the case of a Philadelphia woman injured after exercising for a promotional video for replacement knees. (Polett)
The government has issued a warning about the use of transvaginal surgical meshes to treat pelvic organ prolapse and urinary leakage, noting that thousands of women have reported serious complications including organ perforation, pain, bleeding, infection, and urinary incontinence.
In some cases the mesh -- also called a bladder sling, pelvic sling or pelvic support -- has eroded or shrunk after being inserted, necessitating additional surgeries. As a result, hundreds of lawsuits have been filed against the manufacturers of the urogynecological mesh products, including Ethicon Inc., a New Jersey subsidiary of Johnson & Johnson, which on June 4, 2012 said it would halt sales of most of its mesh products.
If you or a loved one suffered a severe or catastrophic injury as a result of a transvaginal mesh procedure, you should contact a transvaginal mesh attorney for a free evaluation of your case.
Kline & Specter, P.C., with some 30 attorneys, five of whom are also highly experienced doctors, including two OB/GYNs, is representing thousands of women from across the United States in their claims against the manufacturers of transvaginal mesh products. The law firm has the expertise to litigate transvaginal surgical mesh injury lawsuits.
Lee Balefsky, head of Kline & Specter's Mass Tort Department, is a member of the Plaintiffs' Steering Committee involved in all transvaginal mesh lawsuits nationwide. The firm, led by Balefsky, is playing an important role in the litigation nationally by taking depositions of the manufacturers' key employees in the case.
The U.S. Food and Drug Administration (FDA) in July 2011 issued its second notification in three years to doctors and patients warning about the problems with surgical mesh products. It said that “serious complications associated with surgical mesh for transvaginal repair of POP (pelvic organ prolapse) are not rare” (FDA emphasis).
And that the problem was increasing dramatically: The agency received more than 1,000 reports of adverse events involving the mesh to treat POP and stress urinary incontinence (SUI) from 2005 – 2007 but almost triple that number in the following three years.
This has occurred as the urogynecologic surgical procedure using the mesh has also become increasingly popular. Doctors performed more than 100,000 of the operations in 2010, with about 75 percent performed transvaginally.
Unlike prescription drugs, which must be proven safe and effective before being sold, most medical devices face no such requirement.
Pelvic organ prolapse affects many women as they age, with the FDA estimating 30 to 50 percent of all women may experience POP during their lifetimes, with 2 percent developing symptoms such as urinary leaking during physical activity. POP occurs when the tissue holding the uterus, bladder, bowel and rectum become stretched or weak and the organs fall down or slip out of place. The mesh is used as a sort of cradle or nest to hold up a patient’s insides.
But over time, erosion or contraction of the mesh – described as being made of a material similar to that of Rubbermaid storage containers -- has led to complications, with symptoms including bleeding, severe pelvic pain, painful sexual intercourse and urinary problems.
If you think you may have a claim, please call our transvaginal mesh attorneys at 800-243-1100.