FDA Stops Pelvic Surgical Mesh Sales

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The Food and Drug Administration (FDA) ordered medical device companies to stop selling surgical mesh for the repair of pelvic organ prolapse. This decision by the FDA comes after legal and medical battles over vaginal mesh safety.

Vaginal mesh is a synthetic product that has been implanted in millions of women to strengthen weakened pelvic muscles that can cause the bladder, the uterus and other organs to sag into the vaginal area. It has been estimated that roughly 10 million women worldwide have received mesh implants to treat weakening pelvic muscles and alleviate urinary incontinence.

Gynecologists began implanting surgical mesh to repair pelvic organ prolapse in the 1970s, and they began using it in the 1990s for transvaginal repair. The mesh is implanted in the vaginal wall; complications have included bleeding, pain, inflammation and dislodging or protrusion through the wall that can cause infection. Many women have required further surgery to repair resulting damage.

In January 2019, Suzanne Emmet was awarded $41 million verdict by a Philadelphia jury against the medical device maker Ethicon, and its corporate parent Johnson & Johnson, she underwent multiple surgeries to attempt to relieve discomfort, bleeding, infections, painful sex, and other symptoms, from the vaginal mesh implanted in 2007.

In April 2019, another Philadelphia jury awarded $120 million to Susan McFarland after she had the medical device implanted in 2008, she suffered from pelvic pain and chronic urinary tract infections. Surgery to remove the mesh failed to help. The verdict includes $100 million in punitive damages against Ethicon, a Johnson & Johnson subsidiary.

Ethicon stated that they empathize with the women experiencing medical complications, but that they stand by their research and development of the product. They believe that the product continues to be the gold standard of treatment for stress urinary tract incontinence.

Two companies were still selling the pelvic mesh when the FDA entered its order. The FDA stated that Boston Scientific and Coloplast had not demonstrated a reasonable assurance of effectiveness and safety for their devices.

The FDA previously issued several warnings about the devices, but never formally demanded that the products be taken off the market. The FDA said that it had received reports of more than 10,000 serious injuries and almost 80 deaths in 2018.

Seven device manufacturers including Boston Scientific and Johnson & Johnson are paying nearly $8 billion to settle claims of more than 100,000 women.

The FDA believes that women who have already had the devices implanted and are not having problems with them should not take any action, other than to continue with regular doctor visits.

If you or someone you know have suffered from a similar defective medical product, consider speaking with a personal injury lawyer in Phoenix, AZ today.

Thanks to The Law Office of Paul Englander, PLC for their insight into product defect claims and pelvic surgical mesh.