Schlesinger Law Offices, P.A is currently looking for cases involving the:
What is a Vaginal Mesh ?Transvaginal placement of surgical vaginal mesh is a procedure that is used to treat Urinary Stress Incontinence (USI) and Pelvic Organ Prolapse (POP) in women. In October 2008, the Food & Drug Administration (FDA) warned that transvaginal placement of surgical mesh had caused serious and painful complications in hundreds of women.
What are the Risks of a Vaginal Mesh ?For several years, doctors have been recommending the transvaginal implantation of surgical mesh as a treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. After numerous reports and studies of transvaginal mesh side effects, the U.S. Food and Drug Administration (FDA) issued a safety notice in 2008.
FDA Safety Notices
The original 2008 FDA safety notice proclaimed that transvaginal mesh side effects are rare, even though over 1,000 reports of complications were received by no less than nine transvaginal mesh manufacturers.
On July 13, 2011, the FDA issued an update on the original safety notice. The update states that transvaginal mesh side effects are not rare. The notice also states that no clear evidence shows that transvaginal mesh used in the treatment of POP is more effective than traditional treatments without the mesh.
Erosion of Vaginal Tissue
Several transvaginal mesh side effects have been reported to and acknowledged by the FDA. The most common of these is that the mesh can erode vaginal tissue and puncture the vaginal wall. This side effect can be painful and cause other complications, including infection and permanent injury. The treatment of vaginal erosion may involve multiple debilitating surgeries to correct. Some women have not had the problem resolved even after undergoing several surgical procedures.
Other Transvaginal Mesh Side Effects
While vaginal wall erosion is the most common and consistently reported side effect, the FDA has stated that in their 2011 safety update that they are aware of several other transvaginal mesh side effects. These side effects include the following:
• Organ perforation • Urinary complications • Pain • Bleeding • Infection • Painful intercourse
A previously unidentified transvaginal mesh side effect was included in the FDA safety update: mesh contraction. Mesh contraction occurs when transvaginal mesh begins to shrink after it has been implanted. This side effect can cause tightness and shortening of the vagina, resulting in pelvic discomfort and pain.