Risks vs. Benefits of Transvaginal Mesh Surgery for POP

The Food & Drug Administration said that in 2010, doctors performed at least 100,000 prolapse repairs using surgical mesh; about three-quarters of prolapsed repairs were transvaginal. From 2005 to 2007, the FDA received more than 1,000 adverse event reports related to the surgical mesh implanted in women for pelvic organ prolapsed (POP) or stress urinary incontinence (SUI). Then from 2008 to 2010, the FDA initially revealed safety concerns after another 3,000 adverse event reports.

The most frequently reported complications from surgical mesh used to repair pelvic organ prolapse is becoming exposed or protruding out of the vagina (aka erosion), pain, infection, bleeding, painful sexual intercourse, and urinary problems.

Unlike prescription drugs, which have to go through a clinical trial procedure, most medical devices do not have the same requirements. Surgical mesh, used to support organs, doesn't need to adhere to the same stricter policies.

According to a recent report on MSNBC, patients automatically assume that medical devices are tested.

While the FDA has issued safety warnings in October 2008 and most recently July 2011, transvaginal mesh surgery for POP and SUI continue to be a surgeon's preferred method of treatment.

What will it take for women to be better educated about the risks vs. the benefits and for healthcare professionals to choose less risky alternatives if and when appropriate? Lastly, what can the FDA do about allowing safer and improved tested medical devices in the marketplace?

If you or a loved one has suffered painful side effects after transvaginal mesh surgery, by all means, contact Anapol Schwartz law firm to find out what legal action you can take regarding a medical device lawsuit.

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