Tens of thousands of lawsuits have been filed in recent years against medical device manufacturers claiming their transvaginal mesh implants caused pain, perforations, urinary problems, bleeding and other injuries.
The surgical mesh is typically used to fix pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex.
"That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term", Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
Other companies had to remove their products from the market previous year because they did not submit required premarket approval applications, the FDA said.
Two manufacturers have been marketing three surgical mesh products for transvaginal fix of POP.
The products are the subjects of lawsuits by the states of Washington, California, Kentucky and Mississippi.
In its statement, the FDA said it could no longer provide mesh patients "reasonable assurance of safety and effectiveness".
"We are deeply disappointed by the FDA's decision on our premarket approval applications for the Uphold™ LITE Vaginal Support System and the Xenform™ Soft Tissue Repair Matrix, and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the USA who will suffer from pelvic organ prolapse during their lives". "Since it is well known that surgical mesh can cause very painful and serious complications, we agree with the FDA that it should not be approved for use in procedures where there are no benefits compared to surgery without mesh". Implanting surgical mesh for abdominal fix of POP began in the 1970s. In 2002, the first mesh device for transvaginal fix of POP was cleared for use as a class II moderate-risk device.
The FDA news release did not, however, specify a path forward for women with pelvic organ prolapse for whom native tissue fix has not been effective. The FDA issued new recommendations for use in July 2011, and later that year ordered manufacturers to conduct new postmarket studies, after which most companies elected to stop selling the products.
Women who've had the procedure should continue with routine check-ups. There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms.
They should also inform their health care provider if they have surgical mesh, especially if they're scheduled for another surgery or medical procedure.
Women who have had transvaginal mesh placed for the surgical fix of POP should continue with their annual and other routine check-ups and follow-up care, the FDA said.
The National Association for Continence has more on pelvic organ prolapse. An extensive part of the $929 million in Boston Scientific's lawful stores toward the finish of 2018 was identified with the organization's careful work, Needham and Co-investigator Mike Matson stated, including that items represent around 1 percent of organization income. Rather than gather evidence and apply for approval, nearly all of the 30 or so mesh manufacturers, which included Johnson & Johnson and CR Bard, simply stopped selling the devices.