US regulator seeks new safety studies of vaginal implants | WPN World People News

U.S. health regulator has ordered 35 manufacturers of trans-vaginal surgical mesh, used to hold pelvic organs in place, to conduct new safety studies, citing a rise in the number of complications among female patients, including erosion and infection.

In letters sent to the manufacturers including Johnson and Johnson, the biggest maker of vaginal mesh, the Food and Drug Administration (FDA) said it may reclassify the devices in a higher-risk category that would require manufacturers to conduct human clinical trials to get approval for sale.

The regulator said the manufacturers will have to study rates of organ damage and complications linked to vaginal mesh implants.

The FDA move came in response to over 650 lawsuits filed against manufacturers by patient advocates who say the devices have harmed women.

The lawsuits have heightened scrutiny of the FDA programme that cleared the products for sale without human testing.

The devices are commonly implanted in women to repair weakened or damaged tissue and provide support in cases of pelvic organ prolapse (POP). They are also used to help patients with severe overactive bladder known as stress urinary incontinence.

The FDA said it received more than 1,500 reports of complications related to the repairs with mesh, made of synthetic or biological material, from 2008 to 2010, including cases where the mesh eroded into the vagina or caused bleeding and infection.

A FDA report had found a five-fold jump in deaths, injuries or malfunctions tied to the products as compared to such incidence from 2005 to 2007.

In 2010, an estimated 300,000 synthetic meshes were implanted in women to treat incontinence or to shore up pelvic muscles.

The companies could not be immediately reached for comment.

The FDA also said it was concerned about scientific studies that show a lack of clinical benefit from surgical mesh, compared to non-mesh repair.

Surgical mesh has been used since the 1950s to repair abdominal hernias, but doctors only started using the mesh for POP and stress urinary incontinence in the 1990s, a procedure that has grown in popularity.

A case is going to trial later this year.

"These things were basically put on the market without any significant safety testing," said Jeffrey Grand, a lawyer at Bernstein Liebhard in New York, is representing women who are suing manufacturing companies.

"I'm hoping that all of this will bring about some regulatory changes," said Grand.

Source: North America News.Net