FDA Orders Makers of Women’s Surgical Mesh To Stop Selling The Products (#GotBitcoin?)

Agency determines Boston Scientific and Coloplast haven’t demonstrated a reasonable assurance of safety and effectiveness for these devices. Women’s Surgical Mesh To Stop Selling The Products (#GotBitcoin?)

The U.S. Food and Drug Administration ordered the two makers of surgical mesh for women’s pelvic repair to take their products off the market, responding to years of complaints about pain, bleeding and scarring from the devices.

The federal agency, following a safety hearing on the topic in February, said that Boston Scientific Corp. and Coloplast Corp. hadn’t demonstrated reasonable evidence that the mesh products worked better than surgery without the products.

Transvaginal mesh is used to treat a condition called pelvic organ prolapse, in which organs like the bladder, uterus and others sag into the vaginal area. It is estimated that about one in eight women has surgery in her lifetime to treat the condition.

The condition can be treated with conventional surgery that uses a woman’s own tissue. But some surgeons have maintained that the synthetic mesh product can lead to a more permanent repair. Mesh products also are used in hernia repair and urinary incontinence treatment, but these uses carry a lesser risk in the view of surgeons and they remain on the market.

Vaginal mesh products were first cleared in 1996 by the FDA for marketing. But complications, some severe, have been extensive, leading to litigation and billions of dollars in damages over crippling conditions and the need for multiple reoperations in many patients.

Boston Scientific, in a statement, said the company was “deeply disappointed by the FDA’s decision” regarding their products, adding “Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps.”

The company also said it believes “the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives.”

A Coloplast spokesperson wasn’t immediately available to comment.

In 2008, the federal agency issued a notice that serious complications were linked to mesh in some cases. In 2011, it reinforced that message by saying that the complications weren’t rare.

In the FDA’s search of its database on complications preparing for the safety hearing this year, it found 10,391 reports of serious injuries related to surgical mesh for women’s pelvic repair. Further, it said, the reports listed 77 deaths possibly related to the devices.

An advisory panel of outside doctors recommended to the FDA at the hearing this year that it take into account women’s reports of pain, sexual dysfunction and other conditions in making its decision about whether mesh should stay on the market.

“Women’s lives have been changed, and in some cases ruined” by mesh, according to hearing testimony from Diana Zuckerman, president of the consumer group National Center for Health Research.

Both companies at the time of the hearing said they considered mesh safe, effective and an important treatment option.

Jeffrey Shuren, director of the FDA’s medical-device center, said the FDA needed evidence that mesh worked better than surgery without mesh in order to keep the devices on the market. “That evidence was lacking,” said Dr. Shuren, “and we couldn’t assure women that these devices were safe and effective long-term.”

The companies will have 10 days to submit their plan to withdraw these products from the market, the FDA said.

Shares of Boston Scientific were down 5% in afternoon trading. American Depisitary Receipts in Coloplast were down 2.8%.

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