FDA Warns of Serious Complications Associated with Vaginal Mesh

Noble McIntyre on July 28, 2011


Only July 13, the U.S. Food and Drug Administration (FDA) issued a safety communication warning health care providers and patients about vaginal mesh complications. The FDA also warned that transvaginal repair with mesh may not be more effective than traditional non-mesh repair and may actually expose patients to a greater risk.

Background on POP and Vaginal Mesh

Pelvic Organ Prolapse (POP) occurs when the tissues holding the pelvic organs in place become weak or stretched. This typically occurs during pregnancy and vaginal delivery. When POP occurs, the organs will bulge, or prolapse, into the vagina. In some instances, the organs will prolapse past the vaginal opening. The organs that can typically be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel. The dropping of the bowel, uterus, or bladder are non-life threatening conditions. When women undergo a vaginal mesh POP repair, they may become worse off and may face even more severe complications.

Surgical mesh is a medical device that is typically used to repair weakened or damaged tissue. Typically, it is a metallic or polymeric screen that is implanted. Surgical mesh actually began in the 1950s to repair hernias but has evolved into other, modern uses. In 1996, the FDA cleared surgical mesh to be used to treat stress urinary incontinence (SOI) and in 2002, cleared surgical mesh to be used to treat POP. Over the years, surgical mesh products have been incorporated into surgical kits that include tools to deliver and insert the mesh.

Injuries Associated with Surgical Mesh

The most common mesh related symptom for patients undergoing transvaginal POP repair is vaginal mesh erosion. Approximately 10 percent of women undergoing transvaginal POP repair with mesh experience erosion within 12 months of surgery. Also, more than half the women who experience erosion from non-absorbable synthetic mesh require surgical excision during the surgery and some women require two or three additional surgeries.

One of the most dangerous complications of surgical mesh is septic infection. When mesh is implanted in the body, its frayed edges may cut tissue and puncture organs. As a result, some women become septic and suffer infections that the entire torso turns a deep purple. If not treated properly, these infections may lead to death. Currently, at least 10 women have died from a punctured bowel that led to a septic infection.

Other injuries associated with vaginal mesh include prolapsed recurrence, infection, erosion into vagina, dyspareunia, internal bleeding, vaginal scarring, vaginal well-narrowing, urinary problems, punctured bladder, punctured uterus, chronic postoperative pain, and incontinence. The attorneys at McIntyre Law are available to help victims of vaginal mesh complications.  

 


Noble McIntyre

Noble McIntyre is the senior partner and owner of McIntyre Law who focuses primarily on drug litigation and catastrophic injury cases. He is currently representing clients injured by the drugs Paxil, Levaquin and testosterone therapy drugs and by clients affected by oil field injuries. His goal has and continues to be to work diligently on behalf of his clients to achieve the highest and best result for his clients’ injuries while maintaining professionalism and abiding by all ethical standards of his profession. Read more about Noble McIntyre.


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