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Surgical Mesh

The FDA is warning that transvaginal placement of surgical mesh is a risky procedure that can cause serious complications. Surgical mesh is frequently used in place of stitches to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Pelvic organ prolapse is a form of hernia. A hernia occurs when part of an organ or tissue bulges through a weak area of muscle. During pelvic organ prolapse, the tissues that hold the pelvic organs in place become weakened. This weakening causes the pelvic organs, such as the bladder and uterus, to bulge, or prolapse, into the vagina.

Stress urinary incontinence is an involuntary leakage of urine that occurs during physical activity, such as coughing, laughing, or exercise. Like POP, SUI is caused in some cases by weakened pelvic muscles.

During POP surgery, doctors can insert surgical mesh to reinforce the weakened pelvic muscles. Likewise, in SUI surgery, surgical mesh can be implanted to support the urethra. Unfortunately, frequent complications have arisen in the aftermath of these procedures, including mesh exposure through the vagina, urinary problems, infection, pain, bleeding, and even organ perforation. These complications can be debilitating and may require further treatment and hospitalization. In some cases, further treatment and surgery will not be able to resolve the complications.

After a systematic review of information on surgical mesh, the FDA found that the use of surgical mesh gives rise to risks not present in traditional, non-mesh surgery. Furthermore, the FDA found no evidence that surgery with mesh provides additional benefits compared to non-mesh surgery.

The FDA is now urging health care providers to recognize that POP can be successfully repaired without the use of surgical mesh. The FDA is also advising patients to educate themselves on the risks associated with procedure and speak with their doctors about alternative treatment options. Patients who have already suffered complications from surgical mesh placement may be entitled to compensation for damages such as lost wages, medical bills, and pain and suffering.

Click here to read the FDA’s Update on Series Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.