Complications from surgical mesh used for pelvic incontinence and hernia repair

On the same day - July 13, 2011 - the Food & Drug Administration issued two safety alerts for surgical mesh. One alert was for surgical mesh for pelvic organ prolapsed (POP) and stress urinary incontinence (SUI). The second alert was for hernia repair.

POP and SUI safety alert

FDA wants to inform you about the complications that can occur when surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), and provide you with questions to ask your surgeon before having these procedures. This is part of our commitment to keep healthcare professionals and the public informed about the medical products we regulate.

FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. Although rare, these complications can have serious consequences. The reports have not been linked to a single brand or model of mesh.

The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence.

In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.

Hernia mesh safety alert

FDA wants to inform you about complications that may occur with the surgical mesh that is sometimes used to repair hernias, and to provide you with questions you may want to ask your surgeon before having this procedure. This is part of our commitment to keep the public informed about the medical products we regulate.

Hundreds of thousands of hernia repair operations are performed each year both with and without surgical mesh, and patients generally recover quickly and do well after surgery.

However, FDA has received reports of complications associated with the mesh. The complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels. Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence.

Most of the complications reported to us so far have been associated with mesh products that have been recalled and are no longer on the market.

It's interesting to note that the hernia mesh medical devices have been recalled or no longer on the market while the medical devices geared to women for vaginal POP and SUI have not been recalled. Do you have a surgical mesh claim after serious complications from mesh surgery for POP or SUI? Talk to the transvaginal mesh surgery lawyers to find how what your legal options are.

Source for FDA surgical mesh safety alerts

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