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 lost, and some saying that the decision came too late. 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.
Many transvaginal mesh products had already been voluntarily pulled off the market by manufacturers; but there 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 a plan to pull them from the market; saying they “had not demonstrated a reasonable assurance of safety and effectiveness for these devices.”
In response, Boston Scientific issued a statement; “They 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, they firmly believe that patients and their physicians should have a choice of therapies.
Women with complications
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. Only a minority of women “suffer these serious, life-altering complications related to transvaginal mesh, but they’re real.” My perspective, therefore, may differ from someone who does not 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.
Since at least 2011, there has clear evidence that these products are unsafe for treating pelvic organ prolapse and lack any clinically significant benefits. Although they welcome this long-overdue action, this ban comes too late for the thousands of women who have irreparably harmed by these devices; long after the FDA knew the devices had ‘not demonstrated a reasonable assurance of safety.
For women who have had the transvaginal mesh implanted with no complications, experts agree it should stay in place. However, “if you 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.