This Painful Vaginal Implant May Be Banned in Britain. Is the U.S. Next?

Vaginal mesh implant
Traci Rizzo, who had an operation to remove pelvic implants, poses for a photograph at her home in Gulf Shores, Alabama, on July 17, 2015. REUTERS/Michael Spooneybarger

A type of mesh used in the vagina and linked to serious and painful complications may be banned in the United Kingdom. According to the BBC, the U.K.'s National Institute for Health and Care Excellence (NICE) may recommend the devices be used only in research.

The mesh is intended to help keep women's pelvic organs in place inside their bodies. The problem may sound extreme, but it is both real and common. The condition, known as pelvic organ relapse, or POP, happens because organs move around during pregnancy and delivery.

As a result, the muscles that keep a woman's uterus and bladder in place can weaken, causing the organs to drop down. The shift can be uncomfortable and make it difficult for women to control their bladders. Some organs may even start to poke out from the vaginal opening. An estimated 200,000 American women undergo surgery following childbirth to treat POP.

But for some women, the mesh has caused more problems than it has solved. The plastic mesh meant to secure the placement of their organs began to cut into their tissue instead, causing extreme pain. About one in 15 women who had the mesh implanted in the U.K. eventually had it taken out, The Guardian reported in August.

These mesh implants have also been controversial in the United States. One woman, Ella Ebaugh, 51, was awarded $57 million in damages after she sued the manufacturer of the mesh used to treat her urinary incontinence. In the U.S., nearly 55,000 people are suing Johnson & Johnson, a major manufacturer of the product, according to the company's 2016 annual report. Class-action lawsuits against the company have also been filed in Israel and Canada. Other class-action lawsuits over the mesh are ongoing in the U.S. and Australia, The Guardian reported in September.

In April, Johnson & Johnson was ordered to pay $20 million to a woman in New Jersey for mesh-related damages, Bloomberg reported. In 2016, California, Washington and Kentucky sued the company over its marketing of the device, alleging that the company didn't provide enough information about the mesh's possible side effects. (The company told Reuters that the subsidiary that marketed the mesh, Ethicon, "acted appropriately and responsibly.")

Many of the lawsuits emphasize the extraordinary pain linked with the mesh. One woman told the BBC that she had to quit her job; another said she considered suicide and that she and her husband haven't been able to have sex in four years. One woman, writing about her experience in an opinion piece for The Guardian, said a lawyer had contacted her about women who say the mesh eventually forced them to have their bladders removed.

Britain's national healthcare system, the NHS, isn't obliged to follow NICE's recommendations, the BBC noted. The U.S. Food and Drug Administration does not regulate doctors' medical decisions directly, but if the agency were to take the extraordinary step of mandating a recall of the devices, that could be binding on manufacturers.

The FDA has known for several years about the hazards of this product, first approved to treat POP in 2002. By 2010, the FDA had already received nearly 4,000 reports of adverse events associated with the mesh, according to documents from a meeting held in 2011 to review the use of the device; three people died because of complications after the mesh-placing surgery between 2008 and 2010.

After that meeting, the agency concluded that serious complications were "not rare" and that there wasn't "conclusive evidence" that the mesh actually made surgeries more effective for patients.

Short of a recall, the FDA has done other things to address the issues with the mesh, reclassifying both the product and the instruments used with it to categories that give the agency more oversight. The agency also asked companies with instruments used with the mesh that are already on the market to go back to the FDA for clearance by January 2018, according to the Federal Register. However, no steps to outright ban vaginal mesh in the U.S. have yet been taken.