The surgical placement of surgical mesh through the vagina to repair pelvic organ prolapse may expose patients to unnecessary risk without offering clinical benefit above safer options, according to a U.S. Food & Drug Administration warning issued today.
Pelvic organ prolapse occurs when internal organ support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagina.
The condition isn’t life-threatening, but generally results in discomfort and disruption of sexual, urinary and defecatory functions.
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Surgery to repair POP can be performed through the abdomen or transvaginally, through the vagina, using stitches, or with the addition of surgical mesh to reinforce the repair and correct the anatomy.
“There are clear risks associated with the transvaginal placement of mesh to treat POP,” said Dr. William Maisel, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, in an agency release. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
The latest warning updates 2008 communications that addressed concerns about adverse events associated with the transvaginal placement of the mesh. From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007, according to the release.
The most common issues include mesh becoming exposed or protruding out of the vaginal tissue, pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure and urinary problems. Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.
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MassDevice Staff Website The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
