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FDA Halts Pelvic Mesh Sales

Posted Friday, May 10, 2019 by Carl-Erich Kruse

Citing insufficient evidence that the probable benefits of pelvic mesh outweighed its probable risk, the US Food and Drug Administration this week ordered the two remaining companies still selling pelvic mesh to cease sales.

Surgical pelvic mesh, or transvaginal mesh, has been used for decades to treat pelvic organ prolapse and stress urinary incontinence. For pelvic organ prolapse, the mesh has been used to reinforce the weakened muscles and ligaments that support a woman’s pelvic organs. It has been used for stress urinary incontinence to support the urethra or bladder neck to prevent loss of urine due to physical movement or activity.

The FDA’s significant action comes after pelvic mesh litigation grew into one of the largest mass tort cases in our nation’s history. Claims have arisen out of complications including erosion of the adjacent soft tissues (including organs), pain, infection, failure of the device, infection, urinary problems, and incontinence, to name a few. The FDA began issuing warnings and guidance documents regarding mesh use in 2008, and reclassified pelvic mesh as class III (high risk) medical device in 2016.

Over 100,000 claims related to pelvic mesh have been filed since it hit the market. These claims have led to nearly $8 billion in settlements. In addition, the FDA’s tightening oversight on pelvic mesh has reduced to only two remaining mesh manufacturers at the time of the FDA’s latest action. Undoubtedly many women have had successful treatment with pelvic mesh, but the devices’ failure rate was simply too high for the FDA to continue authorizing its sale or distribution in the United States.

The FDA advised that mesh patients without complications continue with their annual follow-ups and, perhaps, simply hope for the best.

Typically, claims such as these are considered products liability claims, and not claims of medical negligence. However, health care providers, including surgeons implanting mesh, may have done so in a negligent fashion, or failed to timely and appropriately diagnose and/or treat injuries occurring as a result of the mesh.

Read the FDA’s notice here. The FDA’s 2001 Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse can be found here.

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