J&J’s Gynecare Prolift — the FDA’s Honor System for Device Approval

Johnson & Johnson (J&J) rarely responds to negative news, which it’s been experiencing a lot of lately, usually relying on the news cycles to wash away unfavorable reports.

But in an unusual move, a J&J spokesman recently did defend the company from the latest blow – that the health care giant sold a synthetic mesh medical device, the Gynecare Prolift, without the regulatory approval by the U.S. Food and Drug Administration (FDA).

Matthew Johnson (no relation) responded to MassDevice in an email that the company followed appropriate regulatory guidelines, even though it sold Prolift three years before it received official FDA approval.

What is the defense? Johnson said the company didn’t think it needed to file a new 510(k) submission under FDA rules. The Prolift was similar enough to another mesh it sold, the Gynemesh PS, which was marketed beginning in 2002.

Johnson & Johnson is a major player that’s been around the block a few times. It is very unlikely the company did not think it needed FDA approval before it began selling a medical device.

“Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations,” according to the spokesman.

An FDA spokeswoman says the agency does not agree with J & J’s assertion that sale of the Prolift device was appropriate and consistent with FDA regulations.

Here’s the background – Prolift was introduced to the market by J & J’s Ethicon division in March 2005, bypassing any form of FDA approval.

That is not the way it’s supposed to work.  The manufacturer is required to at least file an application for marketing under the 510(k) process, naming a predicate which is “substantially equivalent” to the new device it wants to introduce.  It’s not exactly heavy lifting. After an exchange of paperwork, a medical device can be cleared for the market in a matter of months, no safety and efficacy proof required.

No worries – both the Prolift and the 510(k) application for a new version, the Prolift +M, then received FDA approval under 510(k) in 2008. No sanctions, no fines, no warning letter.  Not even a slap on the wrist.

In a way this bad news for J & J underscores the false assurances of patient safety by the FDA’s 510(k) approval process. With no clinical trials required, naming a predicate device as a basis for approval does not, in reality, provide any assurances of safety to patients or their surgeons. All it shows is that the company knows how to file paperwork and follow the FDA rules. Or not.

Company Credibility

In this case the “honor system” of medical device approval, already a fast-track under 510(k), may have shown Johnson & Johnson not to be so honorable, and that could ultimately hurt the company’s credibility in court.

Was it negligent in failing to go through the proper channels for approval? What did J & J know about the controversial mesh product and why didn’t it announce it was seeking the FDA stamp of approval? How were its packages labeled? Was it misbranded by indicating Prolift had received FDA approval when it had not?

The FDA takes misbranding pretty seriously and this could have some serious fallout for the medical device manufacturer in the eyes of the FDA and before a jury.

Prolift is among dozens of different types of synthetic surgical mesh that are causing thousands of injuries in women who receive the device to treat pelvic organ prolapse and stress urinary incontinence. Thousands of women complain of similar symptoms – debilitating pain, nerve entrapment, mesh erosion into the vagina, bladder and rectum, and shooting and stabbing abdominal pain.  And those are the women who survive.

A polypropylene mesh, Prolift is now the focus of about 550 lawsuits across the U.S.

In fact, the Prolift might have gone on being marketed without FDA approval if J & J had not applied for clearance of another device in 2007, citing the Prolift as its predicate.