Government takes closer look at surgical mesh
A medical product implanted into to tens of thousands of women is now facing closer scrutiny by the federal government.
The product is called surgical mesh and has been widely used to treat a condition called Pelvic Organ Prolapse. This condition arises when organs in the pelvis begin to shift or sag, causing incontinence, pain and intimacy problems. The U.S. Food and Drug Administration estimates 50 percent of women suffer from this problem, and mesh has been used to treat POP in tens of thousands of women.
"The standing and the lifting, I would bleed, hurt, go home hurting," said Janet Dotson during an interview with Local 2 Investigates last August.
Dotson was one of several women who spoke to Local 2 and said the mesh implanted in their bodies shifted and eroded.
"It was extreme pain," said Beatrice Santillan.
"It's painful. You're bleeding and you really don't know what the problem is," said another woman who asked not to be identified.
Surgical mesh used to treat POP and Stress Urinary Incontinence has been the target of several lawsuits. The FDA reports it has received hundreds of complaints about mesh causing problems in women.
Local 2 obtained copies of letters sent by the FDA to nearly three dozen mesh manufacturers. The letters order the companies to conduct studies on the affects of mesh used to treat these conditions. These letters come three years after the FDA issued its first public health notification which warned about "serious complications" from the use of mesh.
The FDA has ordered the companies to track women for three years who have had mesh implanted to treat POP or SUI.
Some women complained this scrutiny comes too late, especially since it was the FDA that cleared this product to be marketed as a treatment for these conditions.
"It was cleared for market. It should have been cleared for our bodies at the same time, but it wasn't," said Dotson during the August interview. "Now we have to pay for it."
Most medical devices, such as mesh, do not face the same level of FDA scrutiny as prescription drugs. Last July, the Institute of Medicine called on the FDA to overhaul its system of clearing medical devices for market. Depending on the outcome of the recently-ordered studies, the FDA could then require mesh manufacturers to perform clinical studies, which could trigger greater regulation of the product.