Update: In April 2019, the FDA announced that it was halting all U.S. sales and distribution of transvaginal mesh for the repair of pelvic organ prolapse. The action, which affects the two remaining medical-device companies selling the surgical mesh—Boston Scientific and Coloplast—is the most stringent action the agency has taken to date in the long legal and regulatory battle over this product.
The FDA has long warned about the risks associated with using transvaginal mesh to repair pelvic organ prolapse. (The mesh is also used to treat stress urinary incontinence with fewer complications.) From 2008 to 2010, more than 1,500 adverse effects were reported in the U.S., including pain, infection,bleeding, perforation of internal organs, urinary problems, and a recurrence of the prolapse.
And more than 100,000 women have filed lawsuits seeking compensation as a result of injuries, with the largest one, involving 20,000 cases, settled for $830 million. While some cases have been dismissed, tens of thousands are still pending. Among the manufacturers facing numerous lawsuits are Ethicon Inc. (a subsidiary of Johnson & Johnson) and Boston Scientific.
Some countries, including Australia and New Zealand, have banned transvaginal mesh for pelvic organ prolapse, or POP. In October, the Health Minister of Australia made a public apology to women affected: “On behalf of the Australian government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantations, which have led to horrific outcomes.”
A temporary ban in the U.K. was put in place this past summer for treatment of both urinary incontinence and POP. The U.S. still allows the use of transvaginal mesh, but in 2016 the FDA reclassified the devices used for POP repair from class II (moderate risk) to class III (high risk).
Beware of mesh removal marketers
While the devices indeed carry risks, if you have had mesh surgery for POP, beware of marketers luring women to have the mesh removed through scare tactics that their health is in danger when, in fact, the removal can make matters worse. According to a New York Times article in April 2018, this is done so that the women can be “more lucrative plaintiffs” in the lawsuits being filed against the mesh manufacturers, compared to women who have the devices still implanted.
In the end, this shady business often benefits the marketing firms, lawyers, doctors, hospitals, and finance companies (which provide high-interest loans for the removal surgery) more than the patients. How marketers get the contact information of women with mesh implants is unclear—all the more reason to never provide personal information to unknown sources, such as through online ads or toll-free numbers.
Originally published January 2019. Updated April 2019.
An earlier version of this article first appeared in the UC Berkeley Wellness Letter.