April 18, 2019

FDA Bans Sales of All Transvaginal Mesh

Transvaginal Mesh Sales Halted

The U.S. Food and Drug Administration (FDA) has ordered makers of transvaginal surgical mesh implants to immediately stop the distribution and sale of the products in the United States.

The FDA said that Boston Scientific and Coloplast, the last two companies selling these products in the U.S., have not demonstrated “a reasonable assurance of safety and effectiveness for these devices”.

Transvaginal Mesh Used for Pelvic Organ Prolapse

Transvaginal mesh is used in surgery to repair pelvic organ prolapse (POP) a common medical condition in which the muscles and tissue supporting the pelvic organs (the bladder, uterus, and rectum) become weak or loose. This allows the pelvic organs to press on, into, or out of the vagina. One in eight women will have surgery to repair POP over her lifetime.

History of FDA and Transvaginal Mesh

The FDA approved the first pelvic mesh device for transvaginal repair of POP as a class II moderate-risk device in 2002. Since then, thousands of women and their doctors have filed complaints of injuries resulting from implanted vaginal mesh after POP surgery. The agency issued its first safety communication about pelvic mesh in 2011.

The FDA reclassified vaginal mesh as Class III (high risk) in 2016. As a result of the reclassification, manufacturers were required to obtain premarket approval applications (PMAs), the FDA’s most stringent method of approving medical devices. Some manufacturers voluntarily recalled or discontinued vaginal mesh in the last few years as safety concerns grew.

FDA Ended Sales for Safety of Patients

In reviewing the PMA data submitted by Coloplast and Boston Scientific, the FDA determined that the data didn’t show surgery using mesh was better than surgery using native tissue. Therefore, the benefit of mesh did not outweigh the risk of injury, and the products are not safe to use.

Even though they can no longer sell the devices, Boston Scientific and Coloplast are “required to continue follow-up of the subjects already enrolled in their 522 studies.”

What To Do If You Have Defective Transvaginal Mesh

Any woman who has implanted mesh for POP who is having pain or other complications should contact her doctor immediately. The injuries caused by defective transvaginal mesh include infection, vaginal bleeding or discharge, severe pelvic or groin pain, pain during intercourse, urinary problems, and even organ perforation from implanted mesh eroding into surrounding tissues. Do not delay seeking medical attention if you are in pain.

If you have been injured by a defective transvaginal mesh implant and would like to explore your legal options, call the pelvic mesh lawyers at Thornton Law Firm to talk with Attorney Marilyn McGoldrick. You can also tell us your story online for a confidential, free evaluation of your legal rights. 

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