Bard Meshes Not Fit For Human Implants, Cover-Up Alleged

It is a startling revelation concealed in court documents – C.R. Bard, one of the six primary plastic mesh manufacturers – knowingly sold vaginal and hernia mesh that was made of a material unsuitable for human implantation.

What’s worse was that court documents show executives knew the Marlex polypropylene should not be implanted in patients but tried to keep it a secret.

“Important… these suppliers 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 discussions with these manufacturers.”

Davol is the division of C.R. Bard that oversees hernia mesh implants. It is the same mesh used to treat pelvic organ prolapse and incontinence with plastic mesh implants and slings used to reinforce organs and tissues that have fallen inside the pelvic floor.

Court documents in an upcoming trial show Bard had received the Material Safety Data Sheet (MSDS) which is supplied by manufacturers to the Occupational Safety and Health Administration (OSHA). It warned about the polypropylene resin used to manufacture Avaulta products.

The Medical Application Caution says “Do not use this Phillips Sumika Polypropylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”

That defies logic when you consider that polypropylene medical mesh for hernias and to treat prolapse and incontinence obviously comes into contact with both bodily fluids and tissues.

In response to this smoking gun, a Bard vice president told Bloomberg, the company “acted appropriately in its acquisition of polypropylene resin.”

C.R. Bard had tried to have those emails suppressed but District Judge Joseph Goodwin ruled they represented “a genuine issue of material fact” concerning what Bard knew and when it knew it.

As with many examples, often the cover-up is worse than the initial action.

The first of four cases alleging that the Avaulta meshes made by C.R. Bard are defective is set to begin July 8. In this case, Dan and Donna Cisson will claim the Avaulta mesh caused her to suffer pain, bladder spasms, bleeding and multiple removal surgery attempts.

These are bellwether cases, that is, cases that will test the legal theories. The outcome of those trials will alert the manufacturer it is time to settle with the plaintiffs, or give them enough confidence to continue to deny any liability in court.

More than 3,000 women have filed defective product cases against C.R. Bard in the federal court in West Virginia with similar claims. In this case the jury can award compensatory damages as well as punitive damages.

More than 23,000 cases have been consolidated against six mesh manufacturers in the same court.