Thursday, October 20, 2011

J & J Mesh Product Based on Recalled Product.

Source: Bloomberg

Pelvic Mesh treats incontinence and a condition called pelvic organ prolapse, in which internal organs slump into the vagina. They were allowed on the market as result of the agency’s approval process, known as 510(k), which relies on the notion that if one device has been cleared by the FDA then similar devices need little if any testing in patients.

The chain of approvals that began with Boston Scientific’s device highlight a key flaw in the 510(k) process, said Amy Allina, a policy director at the National Women’s Health Network, a Washington-based advocacy group.  The system lets manufacturers win clearance for a product by citing its similarity to an already approved device, known in FDA jargon as a “predicate.” That second device can be cited as the basis for a third, the third to clear a fourth and so on.

“If a first iteration is recalled, they don’t necessarily look at the second, third or fourth things that are based on that,” Allina said in an interview. The system, she said, “is a mess.”

The story began in 1996, when Boston Scientific won clearance for ProteGen, the first vaginally implanted mesh designed specifically to treat incontinence. Two years later, J&J won approval for a similar device, called Gynecare TVT. Under the 510(k) system, J&J wasn’t required to conduct human testing because the company claimed its device was “substantially equivalent” to the Boston Scientific device.

A year later, Boston Scientific voluntarily pulled about 20,000 ProteGen meshes, saying it had received 123 reports of problems, including discomfort, painful sex, and erosion of vaginal tissue. Nonetheless, J&J and at least two other manufacturers, American Medical Systems and Covidien Plc (COV), soon came out with products that traced their design back to ProteGen.

The FDA has said it doesn’t know the number of women who have received the implants since 1998, though it estimates almost 300,000 were used in 2010.

In the case of vaginal mesh implants, the FDA continued approving the hammock-like devices made by J&J and other companies based on their similarity to Boston Scientific Corp. (BSX)’s ProteGen even after it was pulled amid safety complaints. Today, the makers of the entire category of implants face more than 600 lawsuits from women who claim the devices caused serious injury.

The complaints are the latest to implicate the approval process for medical devices at the U.S. Food and Drug Administration, which has cleared faulty hip implants and numerous other products.

In the case of Johnson and Johnson, this is nothing new.  How may recalls have we seen from this company in the last 36 months.  Where was the FDA when other countries with databases were recalling J&J's faulty hips that now may have affected 34,000 Americans and subjected them to toxic levels of heavy metals.  I guess those guys just don't want to mess up those cushy jobs waiting for them when they leave government service to cash in.

In July, the FDA issued a statement saying it is unclear whether prolapse implants provide any benefit over traditional surgery. The statement came three years after the agency first acknowledged a problem in a 2008 report that said mesh complications were serious, if rare. An advisory panel of physicians said last month that the FDA should demand more clinical testing of the devices.