FDA Ban on Transvaginal Mesh for Prolapse Stirs Controversy

Marcia Frellick

May 03, 2019

CHICAGO — The ban on further sales of transvaginal mesh for pelvic organ prolapse (POP) imposed by the US Food and Drug Administration (FDA) last month has some people cheering, some saying that an important choice for physicians has been lost, and some saying that the decision came too late.

"I support this decision," said Una Lee, MD, a urologist at Virginia Mason Medical Center in Seattle. "Many in the medical community probably do not because I think doctors like choices. They like having all choices available at their disposal."

The ruling pertains only to transvaginal mesh for prolapse, not mesh placed abdominally for prolapse or slings for urinary stress incontinence, which has caused confusion. Some patients are concerned slings will be pulled off the market, but "it's a whole different set of evidence and data. It's apples and oranges," Lee told Medscape Medical News.

Many transvaginal mesh products had already been voluntarily pulled off the market by manufacturers, but there were three left: two made by Boston Scientific and one made by Coloplast. On April 16, the FDA gave both companies 10 days to come up with plan to pull them from the market, saying they "had not demonstrated reasonable assurance of safety and effectiveness for these devices."

Companies Say Physicians, Patients Should Have Choice

In response, Boston Scientific issued a statement: "We are deeply disappointed by this decision and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the US who will suffer from POP during their lives."

Coloplast followed suit: "While mesh sales to treat POP in women account for approximately 0.2% of our global revenue, we firmly believe that patients and their physicians should have a choice of therapies."

But Lee said she sees the effects of complications every day in her practice.

"I have personally treated hundreds of women with complications specific to mesh, so I am an advocate for women who have suffered," she explained. Only a minority of women "suffer these serious, life-altering complications related to transvaginal mesh, but they're real."

"My perspective, therefore, may be different from someone who doesn't see those complications," said Lee, who specializes in pelvic floor repair and will present some of her research at the American Urological Association (AUA) 2019 Annual Meeting this weekend.

I have personally treated hundreds of women with complications specific to mesh, so I am an advocate for women who have suffered.

Transvaginal mesh is only one option for pelvic organ prolapse. It can also be treated with conservative management, pelvic floor physical therapy, nonsurgical pessary use, and other surgery options.

None of the surgeons at Virginia Mason implant transvaginal mesh for prolapse, Lee reported, adding that most there do native tissue repairs, using patients' own tissue to reconstruct their pelvic floor.

Among the possible complications with mesh are that it can come through the wall of the vagina or erode into the bladder.

"Some people say if there's an erosion, just remove it and they're good," Lee said. However, "even when you remove the mesh, patients continue to have chronic pelvic pain and lack of sexual function. Anyone who tries to minimize these patients has not listened to them."

"I feel that the FDA did something on behalf of the women," said Lee, although she acknowledged that "it was not the best solution, per se. In taking it off the market, people will say, 'What about those who need it?' I say, 'What about those who suffered?'"

"Mesh Is a Good Tool"

"I think it's good to have a full armamentarium when planning surgery for patients," said Elise De, MD, a urologist at Massachusetts General Hospital in Boston who specializes in women's pelvic medicine.

In rare cases, "mesh is a good tool to have," although it is not needed in "about 90% of cases," said De, who was involved in research that will be presented at the AUA meeting.

The way mesh was initially used and the marketing were misguided. "Mesh was launched as first-line, which it really never should have been. You should never use mesh in a surgery-naïve patient," she told Medscape Medical News.

"Marketing was directed at expanding the repertoire of surgeons who wouldn't normally be doing pelvic reconstruction by offering them 'an easier way to do it'," she explained. "Those marketing strategies put various levels of safe mesh products into the hands of people who weren't necessarily comfortable with the tissue planes and it was a disaster."

In 2008, "people were learning on cadavers and then going to do the surgery on humans," said De, who said she hasn't implanted transvaginal mesh for prolapse for many years.

She stopped when she started seeing patients with complications being sent to her practice. "I would often feel that it was more the surgical technique than the actual mesh, but certainly there were cases where I thought the mesh itself was the culprit, De said.

"It's traumatizing when you take care of a patient with a complication," De added. "Having seen some pretty significant poor outcomes sent in for salvage, the less excited I became about using mesh."

There is a lack of new products on the market, but there are biologic products, such as human cadaveric tissue, that are long-standing options, she pointed out. There has never been a gold standard for prolapse repair because the anatomy is so variable and research data have not been perfectly randomized, she added.

"I think the human cadaveric products are the best alternative for polypropylene mesh," she said, although she acknowledged a lack of long-term data on those.

"This Ban Comes Too Late"

"Since at least 2011, there has been clear evidence that these products are unsafe for treating pelvic organ prolapse and lack any clinically significant benefits," Michael Carome, MD, director of the health research group at Public Citizen, said in an April 16 statement.

"Although we welcome this long-overdue action, this ban comes too late for the thousands of women who have been irreparably harmed by these devices, long after the FDA knew the devices had 'not demonstrated a reasonable assurance of safety'," he added.

For women who have had the transvaginal mesh implanted with no complications, experts agree it should stay in place.

However, "if you were planning to have mesh placed transvaginally for the repair of pelvic organ prolapse, you should discuss other treatment options with your doctor," according to the FDA statement.

Lee, De, and Carome have disclosed no relevant financial relationships.

American Urological Association (AUA) 2019 Annual Meeting.

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