FDA orders makers of women’s surgical mesh to stop selling the products
The U.S. Food and Drug Administration ordered the two makers of surgical mesh for women’s pelvic repair to take their products off the market, responding to years of complaints about pain, bleeding and scarring from the devices.
The federal agency, following a safety hearing on the topic in February, said that Boston Scientific Corp. and Coloplast Corp. hadn’t demonstrated reasonable evidence that the mesh products worked better than surgery without the products.
Transvaginal mesh is used to treat a condition called pelvic organ prolapse, in which organs like the bladder, uterus and others sag into the vaginal area. It is estimated that about one in eight women has surgery in her lifetime to treat the condition.
The condition can be treated with conventional surgery that uses a woman’s own tissue. But some surgeons have maintained that the synthetic mesh product can lead to a more permanent repair. Mesh products also are used in hernia repair and urinary incontinence treatment, but these uses carry a lesser risk in the view of surgeons and they remain on the market.
An extended version of this report appears on WSJ.com.
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