U.S. halts sales of pelvic mesh tied to injuries in women
18 April, 2019, 20:41
USA health regulators are halting sales of a sort of surgical mesh used to fix pelvic conditions in girls.
The FDA said it "has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices".
In 2016, the FDA reclassified surgical mesh products intended for transvaginal fix to indicate they were the most high risk of devices the agency evaluated, according to an agency statement.
"That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term", FDA's Center for Devices and Radiological Health Director Jeff Shuren said in a news release.
Like most medical devices on the market, the FDA approved pelvic mesh through a regulatory pathway that reviews new products based on their similarities to decades-old devices already on the market, rather than new testing in patients. The finding may complicate the outcome of lawsuits against the companies, which have continued to sell the mesh even as women claimed they caused permanent pain and damage.
Surgical mesh has been used by surgeons since the 1950s to fix abdominal hernias. Boston Scientific said it is "deeply disappointed" in a statement to MedTech Dive and believes "the inaccessibility of these products will severely limit treatment options" for women with pelvic organ prolapse (POP).
About 1 in 8 women have surgery to fix the condition, and a subset of the procedures use the mesh, the agency said. In the 1990s, gynecologists began implanting surgical mesh for the transvaginal fix of the condition and in 2002, the first mesh device specifically for this objective was cleared for use by the FDA, according to the agency's statement. It is the most stringent action the F.D.A. has taken in the lengthy legal and medical battles over vaginal mesh, a synthetic product that has been implanted in millions of women to strengthen weakened pelvic muscles that can cause the bladder, the uterus and other organs to sag into the vaginal area.
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Uphold LITE Vaginal Support System with Capio SLIM (Medical Device licence: 98223) from Boston Scientific. The surgical meshes were the topic of a "60 Minutes" investigation in 2018.
Patient advocates and consumer watchdog groups applaud the FDA's crackdown on mesh. However, the percentage of women undergoing transvaginal POP mesh procedures has decreased in recent years after the FDA began issuing warnings about the risks associated with using transvaginal mesh used for POP fix.
She calls on the FDA and medical device industry to "do the right thing" and stop making and marketing pelvic mesh.
Zuckerman says the agency should require clinical trials for all mesh used in surgeries. Patients should notify their health care professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex.
In the meantime, the FDA has told women who are now implanted with mesh to continue to see their doctors for routine check-ups.
The agency said the women who have had transvaginal mesh used for their condition don't need to take any action if they are satisfied with their surgeries and don't have any symptoms.
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