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FDA Warning: Surgical Mesh for Vaginal Prolaspe Repair has High Risks

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Vaginal prolapse is a condition where the top of the vagina, bladder, uterus, rectum and bowel can protrude pass the vaginal opening. One or more organs can “fall” at the same time. In many cases, traditional surgery is used to repair the walls of the vagina. However, in others, surgical mesh is used to create support for the organ. In regard to the latter, recent FDA findings should be of great interest to those with this problem.

What is surgical mesh?

It is “a device that is generally used to repair weakened or damaged tissue,” the FDA reported. Sometimes, mesh is made of synthetic materials (absorbable and non-absorbable), and other times it is made of absorbable biologic materials. When used in this surgery, its purpose is to stabilize the vaginal walls.

What is the FDA warning?

As early as 2008, the FDA sounded warnings of complications that may be directly linked to vaginal mesh implantation. As of July 13, 2011, an updated warning has been issued with an even stronger message.

This cautionary alert is based on an in-depth review of published medical reports dated from 1996 up to 2011. After a close and careful evaluation of these materials, the FDA discovered that surgical mesh used in transvaginal pelvic organ prolapse (POP) surgery was not better than traditional non-mesh repair. There were a number of cases where mesh eroded through vaginal walls causing pain, infection, bleeding, pain during sex, organ perforation, and urinary problems.

If you’ve had the POP surgery with surgical mesh and are having problems, what should you do?

The FDA advises you notify your health care provider as soon as possible.

If you have had a POP surgery with surgical mesh and are not having problems? What should you do?

The FDA advises to “continue with your annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.”

If you have had POP surgery and do not know whether surgery mesh was used, what should you do?

The FDA advises you to consult your health care provider on your next visit.

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EmpowHER Guest

The FDA has warned recently that the AMS transvaginal mesh implant can cause serious complications following POP or SUI surgeries. Organ perforation, pain during sexual intercourse and more side effects are the subject of the FDA warning. Women have filed lawsuits based on the side effects. For more information: http://www.yourlawyer.com/topics/overview/american-medical-systems-ams-transvaginal-mesh-erosion-side-effect-lawsuit

July 25, 2011 - 12:04pm
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