Recalled Bard Avaulta Mesh Sold on EBay

Sep 10th, 2012 | By | Category: Media Reports

September 10, 2012 ~ You can buy almost anything on eBay, right? Even transvaginal mesh that has been taken off the market?

DrugWatch (here) reports that the Bard Avaulta polypropylene mesh has shown up on an eBay auction including a Plus Posterior mesh. You could buy it for $50 and two Anterior support System products for $200.

We’ve long known that you can buy surgical mesh on eBay. Even today you can find it. See Proceed Surgical Mesh available for $99 in a search today, as well as this nifty 1976 magazine ad for Marlex mesh, made by Phillips Petroleum. Today’s synthetic vaginal and hernia meshes are a petroleum product.

But this is different.

The manufacturer, C.R. Bard recalled the Avaulta Plus in July to avoid fulfilling a January 2012 mandate from the U.S. Food and Drug Administration to 33 mesh manufacturers to begin postmarket studies on their products to determine if they pose an unreasonable risk to women who have been treated with mesh to treat prolapse and incontinence.

This January MDND story lists all of the companies that must comply with the FDA order.

Ethicon, a division of Johnson & Johnson pulled four of its Gynecare meshes off the market in June. See the background story here.

At the time, Ethicon asked the FDA to suspend its request for postmarket studies.

Christine Scott’s Lawsuit Against Bard

The Avaulta Plus is the same type of mesh the Christine Scott had implanted on January 9, 2008 to treat pelvic organ prolapse and urinary incontinence. The Bakersfield, California woman had both the Bard posterior and anterior synthetic mesh and says she immediately began having complications. Scott has endured eight surgeries and says she experiences daily pain, mesh erosion in the vagina and rectum, fecal incontinence, nerve damage, and depression, among other complications.

Read Christine Scott’s story on MDND.

Scott sued Bard and in July was awarded $5.5 million by a Bakersfield jury in a landmark case that may signal how sympathetic a jury will be to the plight of women who were promised an easy fix to an uncomfortable condition.

Her background story is on her new website Mesh Gone Wrong (here).

Scott’s husband was awarded $500,000 in damages because the couple’s intimacy has been ruined by synthetic mesh. Bard is planning an appeal.

Hers was just the first of thousands of lawsuits filed in state and in federal court consolidated in multidistrict litigation (MDL) in Charleston, West Virginia.

In October 2010 the product liability lawsuits naming the Avaulta Biosynthetic, Avaulta Plus and Solo were named in MDL no.2187. The first trials against Bard are set to begin June 24, 2013.

In the Final Master Complaint, filed in the Southern District of West Virginia, plaintiffs say that C.R. Bard knew or should have known that polypropylene mesh is not inert (is not dormant) and is “biologically incompatible with human tissue.”

The Avaulta and a list of other Bard meshes were approved by the FDA under the 510(k) process – relying on a “substantial equivalence” standard and comparing it to a mesh already sold. No clinical trials required.

The complaint lists all of the Bard meshes that are the subject of litigation. Here is a background story.

According to its website, C.R. Bard, a subsidiary of Davol Inc. is “committed to sustainable responsibility with an emphasis on maximizing the positive impact on the health and wellness of society.”

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.