It’s Time to Recall Transvaginal Mesh, Public Citizen Says

The consumer group Public Citizen is calling on the U.S. Food & Drug Administration (FDA) to recall <"http://www.yourlawyer.com/topics/overview/transvaginal_mesh_injuries">transvaginal mesh used to treat pelvic organ prolapse (POP). According to the group’s newly-filed petition with the FDA, transvaginal mesh devices “offer no significant benefits but expose patients to serious risks and the potential for permanent life-altering harm.”

In 2010, approximately 300,000 women in the U.S. had surgery to repair POP, 75,000 of whom had surgical mesh transvaginally implanted, according to the FDA. Public Citizen estimates that approximately 67,500 of these procedures used a non-absorbable transvaginal mesh device.

“Surgical mesh in POP treatment procedures needlessly exposes patients to a wide array of serious risks, many of which can permanently alter women’s quality of life,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately.”

As we’ve reported previously, the FDA is well aware of the problems posed by the use of transvaginal mesh in POP surgery. The agency first issued a warning for transvaginal mesh complications in 2008. Then in July, the agency issued a second warning, stating complications associated with transvaginal mesh products used in pelvic organ prolapse repair are not rare. In that alert, the FDA said it had received more than 2,800 complaints about transvaginal mesh complications since 2009. Of those, more than 1,500 were associated with pelvic organ prolapse repair, and three involved fatalities.

The most recent alert also stated that it is “not clear that transvaginal POP repair with mesh is any more effective than traditional [transvaginal surgery without mesh] … and may expose patients to greater risk.” In September, the FDA is scheduled to hold an advisory panel meeting to debate whether transvaginal mesh devices should be required to undergo more testing.

Dr. L. Lewis Wall, a professor of obstetrics and gynecology and a bioethicist at Washington University in St. Louis, joined Public Citizen in calling for the transvaginal mesh recall, and was listed as a co-petition on the FDA petition.

“Indeed, there is substantial evidence that such mesh is neither safer nor more effective than traditional native tissue repair operations for these conditions, without the use of synthetic mesh, and that the use of such mesh is associated with serious and sometimes irreversible harm to the patients in whom it is used,” said Dr.Wall. “I commonly see patients who have been harmed by these mesh products in my own clinical practice.”

Another doctor was quoted in a Public Citizen statement saying he does not use the devices for POP repair because of complications he has seen in his practice.

“I have refused to use any transvaginal mesh kits for POP. On a weekly basis, either I or my colleagues evaluate and treat patients suffering from the consequences of the non-absorbable mesh kits,” said Dr. Daniel S. Elliott, a urologic surgeon specializing in female urology and POP at the Mayo Clinic in Rochester, Minnesota. “The patients have suffered needlessly because the standard POP repair without mesh, in properly trained hands, is easy, fast and effective, avoiding the unique complications associated with non-absorbable mesh kits.”

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