ALERT: WHY SHOULD I BE WORRIED ABOUT VAGINAL MESH?
On July 13, 2011 the FDA issued a safety communication warning women that the continued use of transvaginal mesh was an area of "continuing serious concern" and reporting that serious complications from the use of this mesh are not rare. The safety concerns relate to all brands and all manufacturers of this product and represent a major shift in policy from the FDA's October, 2008 notification that complications were rare. Over a 3 year span, manufacturers have reported adverse events in over 1000 surgeries to the FDA. The FDA believes that this number is grossly understated.
The FDA also announced that it will hold a meeting on September 8 and 9, 2011 to discuss and make recommendations regarding the safety and effectiveness of vaginal mesh.
WHAT IS VAGINAL MESH?
Vaginal mesh is a synthetic, knitted, woven mesh usually made from polypropylene which is placed in a woman's vagina to reinforce the internal structures that support the pelvic organs. When the muscles become so weak or stretched that the organs drop from their normal position into or out of the vagina (prolapse) surgical repair may be necessary.
Mesh is used in an effort to strengthen the support and to encourage the growth of the woman's own tissue in the vagina to reinforce and strengthen the weakened tissue and to provide organ support. Vaginal mesh is typically used in a case where an organ such as the bladder, uterus, small intestine, the roof of the vagina, or the urethra bulges into or out of the vagina. This occurs due to weakness or stretching in the muscles which support the pelvic floor such as after childbirth.
A 2011 study published in the Journal of Obstetrics and Gynecology Canada stated "Until adequate effectiveness and safety evidence is available, the use of the new TVM devices for prolapse repair should be considered experimental and restricted to use in investigative trials. Vaginal mesh products are primarily made by Johnson& Johnson, Bard, Boston Scientific, and American Medical Systems under a variety of brand names.
WHAT CAN I DO IF I HAVE VAGINAL MESH?
- Continue with your annual and routine checkups with your doctor if you are having no problems.
- Contact you doctor with any questions you may have regarding vaginal mesh.
- Tell your doctor at once if you develop symptoms such as persistent vaginal bleeding or discharge, pelvic or groin pain, pain with sex or any other unusual pain.
- Let every doctor know that you have surgical mesh so they can take necessary precautions.
Contact a Vaginal Mesh Attorney About the Vaginal Mesh Lawsuit
If you or a loved one has experienced vaginal Mesh complications, please consult our attorneys for a no-cost consultation at 1-800-576-2550 or contact us online.
Our California medical device lawyers have a number of cases pending throughout the country and have been evaluating numerous other cases. We have the experience to prove your case and the compassion to understand the life altering effects of vaginal mesh complications daily life and activities.
