HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Wednesday, October 22, 2008

FDA: Incontinence Surgery Linked to Complications

The Washington Post reports that federal officials say a type of mesh used in surgeries to treat severe incontinence, cases of prolapsed uterus and other women's health problems has been linked to serious but infrequent complications.  The Washington Post writes,

SurgeryThe Food and Drug Administration said this week it has received more than 1,000 reports in the last three years of problems with surgical mesh used to repair pelvic organ prolapse and stress urinary incontinence. The mesh is inserted through the vagina, using minimally invasive surgical techniques.

The complications include erosion of the mesh through vaginal tissue, infection, pain and urinary problems. Some patients have experienced a recurrence of the original condition that the surgery was supposed to resolve. Others have had to undergo repeat surgeries to remove the mesh. Some suffered significant loss of quality of life, including pain during sexual intercourse.

The FDA said it has received reports of complications from nine different manufacturers. It is investigating the cause of the problems, which could include the patient's age and overall health, the mesh material and its size and shape, as well as specific techniques used by surgeons.

In the meantime, federal health officials are advising doctors to:

-Get special training for each mesh placement technique, and be aware of risks.

-Follow patients closely for infection and erosion of tissue.

-Watch for complications that could result from instruments used in surgery.

-Fully inform patients about the possible complications.

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