Product News and Recalls

Despite injuries, manufacturer will sell device

Even as Johnson & Johnson has announced its intention to stop selling vaginal mesh implants, at least one other company intends to continue marketing them despite reports that the devices are severely injuring thousands of patients.

A Bloomberg report quotes Blaine Davis, Endo Health Solutions senior vice-president for corporate affairs, as saying: “As a company, we’re very committed to these categories. We are actually investing behind these products.”

Davis said the company, which sold about $85.5 million in women’s health meshes in the past fiscal year, is putting more money into training doctors about how to use the products and plans to conduct studies to prove their safety. Company officials are discussing the scope of the studies with the U.S. Food and Drug Administration.

In January, the FDA ordered Johnson & Johnson and 30 other makers of vaginal mesh implants to study organ damage and other health complications blamed on the devices.

Consumers Union takes issue with the FDA’s 510(k) process, which mandates approval of medical devices if they’re “substantially equivalent” to devices already on the market. By law, the FDA can only consider whether the new device is similar to one already approved and no evidence of clinical testing is required – even when the device it is based on has been recalled by the manufacturer due to safety problems.

But some consumer groups, including the Consumers Union, maintain that the devices are inherently unsafe and only made it onto the market because of a flawed FDA approval process.

The vaginal mesh implants are surgically implanted to treat urinary incontinence and pelvic organ prolapse, a condition where organs drop out of their normal position in the pelvis. They’re ostensibly based on an earlier mesh approved decades earlier to treat hernias. But the original device was implanted in a different part of the body using a completely different process, and has been involved in a recall.

But the FDA’s 510(k) process requires the agency to approve medical devices deemed similar to products that were previously approved – even if the original prodicts were subsequently recalled.

Since the vaginal mesh was approved, thousands of women who received the device have filed lawsuits over complications, the most common of which concern the mesh eroding and protruding through the walls of the bladder or vagina.

If you have a vaginal mesh implant, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a mesh lawyer to discuss your legal rights.

See the Bloomberg report here:

http://www.bloomberg.com/news/2012-06-04/j-j-tells-judge-it-will-stop-selling-vaginal-mesh-implant.html