Manufacturer Knew Vaginal Mesh Product Wasn’t Fit for Human Use

Ever since it came on the market, vaginal mesh has proved problematic and has become the subject of thousands of lawsuits. Used surgically to treat prolapsed pelvic organs (those that have dropped out of normal position) and urinary incontinence, mesh products were marketed to doctors as an easier way to do a surgery that had required special additional training.

We’ve written about how these products have punctured organs and migrated out of position. Last month, Bloomberg reported that one vaginal mesh manufacturer, CR Bard Inc., sold a vaginal mesh product made of plastic that the company itself had said was not suitable for human implantation.

That disclosure came in a lawsuit over Bard’s Avaulta line of implants that claimed that managers at Bard’s Davol unit used a resin-based plastic made by Chevron Phillips Chemical Co. after the material’s supplier officially warned that it shouldn’t be implanted permanently in people.

In emails from 2004 and 2007, a Davol executive warned colleagues not to tell Chevron Phillips or other resin makers that the company was using the material in medical devices placed in humans.

As reported by Bloomberg, one email from a Bard vice president said suppliers such as Chevron Phillips “will likely not be interested in a medical application due to product-liability concerns. It is likely they do not know of our implant application. Please do not mention Davol’s name in any discussion with these manufacturers.”

As Bloomberg noted, medical device manufacturers have used polypropylene for years to make products such as sutures, catheters and artificial-heart components because that material is considered to be “biocompatible” and won’t be rejected by the human body.

The required safety document that Chevron Phillips filed with the U.S. Occupational Safety and Health Administration about the polypropylene used in some Bard hernia and vaginal implants said:

“Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.

“Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Phillips Sumika Polypropylene Co. under an agreement that expressly acknowledges the contemplated use.”

It said that the resin-based plastic “may react with oxygen and strong oxidizing agents, such as chlorates, nitrates and peroxides,” and the plaintiff’s lawyers said human bodies can produce such oxidizing agents, causing the mesh to erode.

Plaintiff Donna Cisson’s trial began last week in West Virginia. But two days into it, the judge declared a mistrial because, contrary to a prior ruling that marketing information wouldn’t be allowed, one witness mentioned that Bard had withdrawn its products last year. Cisson claims the mesh caused her pain, bleeding and bladder spasms that required follow-up surgeries. She may seek punitive damages if jurors eventually hold Bard liable for compensatory damages and find the company’s conduct justifies the additional amount.

The judge in her case is overseeing 20,000 lawsuits against Bard, Johnson & Johnson, American Medical Systems, Coloplast Corp. and Cook Medical Inc. alleging injuries from vaginal mesh implants. The companies have denied wrongdoing in court filings. In addition to Cisson’s claims, other plaintiffs who had the mesh implanted to support weakened pelvic muscles and treat urinary incontinence suffered organ damage and painful sexual intercourse. They said the mesh degrades and shrinks over time.

The FDA issued a consumer alert about vaginal mesh in 2011, saying that “Surgery to repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI) that involves the placement of a mesh material through the vagina may expose women to a greater risk of complications than would other forms of the surgery.

“The number of problems reported to FDA has continued to climb since the agency first issued a safety communication about surgical mesh in 2008. It is not clear that POP repair through the vagina with mesh is more effective than traditional nonmesh repair in which surgeons repair the damage with stitches alone. FDA continues to evaluate the effects of using surgical mesh to repair SUI.”

The Bloomberg story said that 300,000 women had pelvic organ prolapse surgery in 2010, and that mesh was used in about 100,000 of those procedures. Of the more than 250,000 surgeries for incontinence that year, about 8 in 10 involved vaginal mesh implants.

Last year, the FDA ordered Bard, J&J and other mesh makers to conduct three-year studies of rates of organ damage, infection and painful sex linked to the devices after women’s groups called for their removal from the market.

These manufacturers are used to litigation: In February a jury decided that J&J and its Ethicon unit must pay more than $11 million in damages to a woman who blamed the company’s Gynecare Prolift implant for her injuries. Last year a jury awarded $3.6 million to a woman who blamed Bard’s Avaulta Plus implant for injuring her.

The Avaulta product was pulled off the market last year after seven years. J&J said last year it would stop selling four lines of vaginal-mesh implants, claiming that the reasons were not related to safety.

In the Cisson case, Bloomberg said, the mesh was cleared through the FDA’s 510(k) process. That allows medical devices to reach the market without human testing if they are similar to products currently on the market. Several companies were marketing vaginal-mesh implants when Bard’s Avaulta Plus was approved in 2007.

Erik Gordon, a business professor at the University of Michigan, told Bloomberg that the Avaulta case is an abuse of the 510(k) process. “The alleged conduct is unconscionable,” he said in an e-mail. “How can anyone ever trust a company that knowingly disregards safety warnings from its own supplier and covers up its conduct?”

According to Bloomberg, a gynecologist who worked as a Bard consultant on the vaginal implants testified in a deposition that he suggested clinical trials of the devices, but that Bard rejected the idea because the vaginal-mesh technology was developing so quickly that a multiyear clinical trial would cost several million dollars and that results would be outdated in the three or four years it would take to get the study published.

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