FDA Warns Transvaginal Mesh POP Treatment Carries Serious Risks

There are two types of surgical meshes used: absorbable and non-absorbable. Absorbable meshes are made from thoroughly disinfected animal tissues like skin and intestines. These meshes are designed to be slowly broken down by the patient’s body as their muscles heal. Synthetic vaginal mesh implants are made out of artificial materials and are designed to remain in the body permanently.

In July of 2011, the FDA released a safety communication regarding transvaginal placement of surgical mesh for pelvic organ prolapse. The warning stated that a review of the evidence found that vaginal mesh introduced a number of risks not found in the traditional, non-mesh surgical procedures used for treating POP.

Per the FDA’s website, the “most common and consistent” complaint was mesh erosion. In mesh erosion, the mesh works its way through tissue. Mesh erosion can be a debilitating complication for affected women. This can require multiple surgeries to repair. Additionally, the mesh can contract or shrink under certain circumstances, causing damage to the pelvic organs. The FDA’s literature review did not find a single brand or model of vaginal mesh implant that was more prone to problems.

The FDA’s literature review found that proper placement can improve the outcome of using mesh. However, this does not eliminate the risk compared to traditional, non-mesh surgery.

Additionally, vaginal mesh implants have been linked with other serious medical problems. These include things like vaginal scarring, pain during sex, urinary problems, bladder infections, and perforations of the bladder and bowel. Internal injuries like this can potentially lead to life-threatening complications like infection.

Lawsuits have been filed by women who suffered these effects after being implanted with vaginal mesh. These vaginal mesh injury lawsuits seek compensation for the surgical intervention to remove the mesh, which can require multiple surgical procedures. The lawsuits also seek compensation for pain and suffering and lost wages due to recovery time.