J&J Selling Vaginal Mesh Without FDA Clearance Might Make A Good Headline, But Doesn’t Change Much

In short

Johnson & Johnson is in the news again this week. This time, Bloomberg is reporting that “the company sold a vaginal mesh implant for three years before U.S. regulators approved the device”. The device is now the subject of more than 550 lawsuits by women who claim it injured them. The questions arises; would formal FDA approval have been granted if sought? Well, yes…because that’s exactly what eventually happened in 2008. So while that doesn’t right a potential wrong, it maybe distracts from the real issue of how to handle the situation right now.


Meshes are commonly used in surgery, not least to treat incontinence or help women with pelvic organ prolapse. Several mesh products, like the Gynemesh and the Prolift, are threaded in place through an incision in the vagina, hence the descriptor.

We’ve reported on our pages increasing concerns relating to this class of product, and indeed FDA has asked companies, not just J&J, to provide more data relating to their performance, specifically organ damage and complication rate.

According to the Bloomberg article, which can be found here, Ethicon, a division of J&J, introduced the Gynecare Prolift device in March 2005, describing it as an “innovative and effective surgical option” for weakened pelvic muscles. The U.S. Food and Drug Administration said it learned of the Prolift in 2007 and subsequently cleared it in May 2008.

According to an FDA spokeswoman, quoted in the Bloomberg article, the company’s position was that it could market the Prolift without approval because it was so similar to an approved device.

“FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance, she said.

Regulatory red-herring, but a potentially expensive one

The issue comes down to money again. Even though FDA clearance would probably have been granted and even though the problems with meshes aren’t exclusively focused on this product, it seems likely that J&J’s so-called “unauthorised” sales might, if proven, cost it more to resolve lawsuits over the product, despite the fact that the reader, when faced with all the facts could easily conclude that the company acted in good faith and claims to have taken its cues from FDA’s own guidance.

Legalists hovering

It’s a cheap shot isn’t it?

“They were initially able to put the Prolift on the market without even telling the FDA,” said attorney Adam Slater, who is suing J&J on behalf of more than 100 women. “Even though Johnson & Johnson supposedly lives by a credo to put the patient first, this is an example of fast-tracking a product to market quickly rather than going to the FDA first.”

Might this say more about FDA’s processes than Ethicon’s behaviour?

The FDA’s 510(k) approval process permits companies to introduce products, in many cases without clinical trials, if the agency decides they’re similar to devices already for sale, or so-called predicates. But that’s not what we’re talking about here. Below the 510(k) route lies what we might think of as the “range addition” route, where a product is best thought of as a “variation on a theme” and as such requires no formal approval from FDA. The pragmatist in all of us must sign up to the existence of this route because it simply doesn’t make sense for any party to be required to resubmit with all the costs and time that entails, every time they add a new size of scalpel blade.

Fuelling J&J’s decision to call the new product an insignificant change was the fact that Gynemesh (already marketed since 2002) and Prolift are made of the same nonabsorbable polymer, the Prolift kit featuring pre-cut mesh and instruments to help surgeons implant the device.

So, back in 2005 it seems Ethicon decided their new product was tantamount to that “new size of scalpel blade”, so chose not to make a 510(k) submission. When FDA spotted the product in 2007, it obviously decided it was rather too “different” to justify the “insignificant change” (compared with Gynemesh Prolene Soft Mesh) principle J&J had been working on. FDA told J&J to submit a 510(k) application to review the Prolift. In fact the product only came to light when it was used as a predicate device in a 510(k) submission for a follow-on device, the Prolift+M, which the company had presumably decided was “different enough” to justify a submission, given that it contained absorbable materials.

So did J&J act appropriately?

According to Bloomberg, J&J introduced the original Prolift in March 2005 after “applying the relevant FDA guidance and based on the safety and effectiveness” of Gynemesh, Matthew Johnson, a spokesman for the company, said in an e-mail.

“Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations,” said Matthew Johnson. “Numerous clinical studies suggest that when combined with proper surgical technique, surgical mesh can improve patient outcomes, and Ethicon’s devices are among the most studied devices on the market for this condition.”

When an FDA reviewer contacted Ethicon in July 2007 about the conclusion that the change was insignificant, the company cited the agency’s guidance document, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” according to FDA’s spokeswoman and Johnson.

“The lead reviewer determined that Ethicon should have submitted a separate 510(k) for Prolift.”

Would FDA have made the 510(k) demand if problems weren’t appearing?

Only a cynic would believe that FDA’s stance might be defensive of their own rules at a time when Vaginally inserted meshes are increasingly high profile. There’s no doubt, however, that sending the company to the naughty step over this does somewhat deflect attention. Has anyone taken a close look at FDA’s guidance on what constitutes an insignificant change, we wonder?

Add to that the motivation of the victims, whose damages claims may be bolstered if their legal teams can establish that J&J flouted the rules, even though strict adherence to FDA’s eventual position would likely have made no difference to the product’s availability.

It makes J&J look like such a soft target, doesn’t it? We’ll be feeling sorry for them next.

Source: Bloomberg