Thursday, July 14, 2011

FDA warns mesh used in surgery poses risk

Problems seen in vaginal procedure
By Deborah Kotz and Robert Weisman
Globe Staff / July 14, 2011
Women who have vaginal surgery to fix a common gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used, according to a safety communication issued yesterday by the Food and Drug Administration.

The agency warned patients and surgeons to consider other options.

The FDA said it plans to convene an advisory committee of experts in the fall to determine whether to ban the mesh - manufactured by Natick-based Boston Scientific Corp., Covidien PLC of Mansfield, and several other companies - for this procedure.

About 100,000 women with pelvic organ prolapse are treated with plastic mesh each year, but in most cases, the agency said, the condition can be treated successfully without mesh.

Mesh-related problems reported to the FDA include pain ful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.

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1 comment:

Christine Montgomery said...

The surgical mesh kits specifically designed for pelvic organ prolapse repair have been first cleared by the FDA in 2002. Over the years the number of reports received by the FDA indicates that these products might hold serious risk and a reclassification might be required along with properly conducted clinical trials.