The Food and Drug Administration on Tuesday ordered the two remaining medical device companies selling surgical mesh for the repair of pelvic organ prolapse to stop all sales and distribution in the United States.
It was the most severe action the F.D.A. has taken in the protracted 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.
The number of serious complications from the device has increased significantly over the years, prompting the F.D.A. to ask manufacturers to submit more evidence that the devices were safe and would benefit patients.
In announcing its decision on Tuesday, the F.D.A. said that the two manufacturers, Boston Scientific and Coloplast, had not demonstrated a reasonable assurance of safety and effectiveness for the devices.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair pelvic organ prolapse,” said Dr. Jeffrey Shuren, director of the F.D.A.’s Center for Devices and Radiological Health. “We couldn’t assure women that these devices were safe and effective long term.”
Shanin Specter, a lawyer who has won several big jury verdicts against firms that manufactured the pelvic mesh, was pleased by the ban.
“This is a good step forward,” he said.
The disputes over the safety of pelvic mesh have gone on for over a decade. Until Tuesday, the F.D.A. had never formally demanded the products be taken off the market, but had issued a number of warnings about the devices. The agency had reported earlier that it had received more than 10,000 complaints of serious injury and nearly 80 deaths as of last year.
Worldwide, it has been estimated that nearly 10 million women have gotten mesh implants to treat weakening pelvic muscles and alleviate urinary incontinence. Roughly 10 to 15 percent have suffered complications, in some cases requiring the mesh to be removed in a second surgical procedure. In light of the warnings and complaints from women about severe pain and bleeding from mesh implants, a number of the manufacturers had voluntarily stopped selling them.
In all, more than 100,000 people filed claims against the major manufacturers in both federal and state court. The litigation has been costly to seven device manufacturers, including Johnson & Johnson and Boston Scientific, that made the products. Johnson & Johnson stopped selling them several years ago. The seven companies so far have agreed to pay out more than $8 billion.
But some of the women, who continue to suffer pain and urinary problems, even after the mesh is removed, have faulted the lawyers for taking too much of the settlement money.
Gynecologists have been implanting surgical mesh to repair pelvic organ prolapse since the 1970s, and began using it for transvaginal repair of the condition since the 1990s.
Boston Scientific, which had filed two applications for its devices, criticized the agency’s action.
“We are deeply disappointed by the F.D.A.’s decision on our premarket approval applications” for two products, said Kate Haranis, a spokeswoman for the company. The company, she added, believes “the inaccessibility of these products will severely limit treatment options for the 50 percent of women in the U.S. who will suffer from pelvic organ prolapse during their lives.”
Coloplast could not immediately be reached for comment.
