The Food and Drug Administration (FDA) decided not to impose an outright ban on sales of a widely used device for women with pelvic-organ prolapse, but new rules are clouding the future of pelvic mesh products used in a common gynecological surgery.
At least 135,000 women and their families have filed personal-injury lawsuits against seven makers of pelvic mesh products.
That includes cases against devicemakers with Minnesota ties: American Medical Systems (46,600 claims), Boston Scientific Corp. (more than 30,000), Medtronic’s Covidien business (11,500), and Coloplast (at least 2,300), according to court records and securities filings.
Last week the FDA imposed stricter regulation on transvaginal mesh devices like those at issue in many of those lawsuits. The agency ordered transvaginal mesh-makers to submit new safety and effectiveness data on pelvic organ prolapse surgeries by the summer of 2018.
That order makes it likely some companies will stop selling mesh devices for the procedure, rather than go though a lengthy regulatory process with the FDA, said longtime Minneapolis regulatory lawyer Bob Klepinski.
“This will weed out some of the folks,” Klepinski said.
One in 10 women have a pelvic organ, like the bladder, drop or “prolapse” into the vagina following weakening of surrounding muscle tissue from childbirth or hysterectomy.
The stretched-thin muscle tissue can be reinforced surgically with a mesh, similar to hernia repair surgery. However, the FDA says implanting mesh through a vaginal incision introduces risks of infection, severe pain, bleeding and future re-operations while not consistently working more effectively than other prolapse surgeries, like native tissue repair or surgical approaches through the abdomen.
The manufacturers have vigorously defended the safety of their products in the handful of mesh lawsuits that have gone to trial so far, but they’re reluctant to make public comments about the devices amid ongoing litigation and settlement talks.
About 59,000 of the 135,000 mesh lawsuits are consolidated in a federal court in West Virginia. Taken together, they represent by far the largest group of ongoing multidistrict litigation cases related to health care, federal court records from December show. Only some of the lawsuits relate to the specific procedure of transvaginal prolapse repair.
The FDA has been evaluating the safety of various mesh devices since at least 2008. The FDA made a preliminary recommendation in 2011 to reclassify some mesh devices as Class III, the highest-risk category, and ordered devicemakers to study their use the following year.
In public comments to the agency, scores of women asked for a nationwide ban or recall of the devices. Some women told the agency that they were never told about the true risks of the surgery, and others said they didn’t find out about mesh until after it was used on them.
Last Tuesday, the FDA announced in the Federal Register that it “does not believe that there is sufficient evidence at this time to support the banning of this device. … The collection of additional clinical evidence on these devices is needed.”
Those conclusions applied only to transvaginal mesh surgery, not implants via abdominal surgery, nor to the similar mesh “slings” used to treat stress urinary incontinence.
Federal data show that doctors perform about 200,000 surgical repairs of prolapse each year, making it the most common inpatient procedure performed in women age 70 and older.
Some researchers have predicted that the rate of gynecological surgeries for prolapse will increase in coming decades, as the baby boomer population ages.
Last week, though, devicemakers did not use the FDA announcement as an occasion to affirm their future support for mesh devices.
“These rules are still new. We are evaluating what this means to Boston Scientific,” company spokesman Tom Keppeler said, noting that it would be typical for the company to announce product commentary during earnings reports. The company’s next report is scheduled for Feb. 4.
Minnetonka’s American Medical Systems, now operated as Astora Women’s Health and owned by Ireland-based Endo International, said it had been expecting the FDA actions and plans to continue its studies to meet the new requirements.
A Medtronic spokesman noted that the company does not make mesh devices. Covidien, which Medtronic acquired one year ago this month, was targeted by mesh litigation because two of its subsidiaries used to supply mesh products to another medical-device company, C.R. Bard. Medtronic is negotiating settlements of its cases.
The FDA order gives companies 30 months to submit premarket applications (PMAs) with new data on the safety and effectiveness.
“We cannot predict whether manufacturers will choose to submit PMAs for these devices,” spokeswoman Deborah Kotz said in an e-mail. “FDA is allowing manufacturers to submit clinical data in their PMA that was collected through 522 studies that we ordered them to conduct in 2012.”
Joe Carlson • 612-673-4779
Regulating Mesh Safety
2008: A public health notification from the Food and Drug Administration warns of serious but rare complications with pelvic mesh implants.
2011: Following in-depth study, FDA announces mesh complications are not rare when used to treat pelvic organ prolapse (POP), and that mesh devices introduce new risks but may not be more effective than other treatments for POP.
2012: FDA orders device makers to monitor and report post-procedure complications from mesh devices.
2014: FDA proposes stricter regulation of mesh devices, including reclassifying them under the highest-risk category, Class III.
2016: The agency formally reclassifies mesh devices for POP as Class III, requiring companies to do new safety and effectiveness studies.