FDA Warns of Transvaginal Mesh Complications

Transvaginal placement of surgical mesh to treat pelvic organ prolapse could result in serious complications, FDA officials warned Wednesday. The agency said it has received almost 3,000 reports of complications from surgical mesh implants used to treat pelvic organ prolapse.

Pelvic organ prolapse occurs when one of the pelvic organs slips from its regular location to press against the vagina and cause pain, often after childbirth or a hysterectomy. Surgical mesh is often used to repair those weakened tissues. The FDA said that serious complications are “not rare,” and that the operation could expose patients to greater risk than reward.

Frequent complications reported by surgical mesh makers include mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. According to new recommendations issued by the FDA, patients should be made aware that implantation of surgical mesh is permanent, and may cause serious side effects that include scarring and narrowing of the vaginal wall.

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