Transvaginal Mesh: Restricted Materials Included?

As multiple lawsuits continue against the manufacturers of transvaginal mesh products, one particular case has taken a unique twist. C. R. Bard, in common with other medical device companies, faces allegations that its TVM was defective and has harmed thousands of women. Unlike other manufacturers, though, questions have been raised about the possible inclusion of a prohibited material in the mesh itself.

Some plaintiffs have suggested that the company’s reluctance to have the records made public could mean that the emails include evidence that the material was used.

Raw polypropylene resin is covered by a Material Safety Data Sheet, issued by its maker, which warns that the resin should not be used for surgeries which involve permanent implantations. Transvaginal mesh used in the treatment of organ prolapse is placed on a permanent basis, and as such, all TVM products should be free of this restricted material. While going through email records which Bard had asked to be sealed under confidentiality laws, some plaintiffs have suggested that the company’s reluctance to have the records made public could mean that the emails include evidence that the material was used. Additionally, this would mean that Bard is attempting to block the emails’ usage despite them being relevant to the case.

Bard opposed the reopening of discovery on this topic, pointing out that discovery had previously been completed. West Virginia Magistrate Judge Eifert, however, disagreed, finding that the fact the emails were hidden in more than half a million other pages of documents made them difficult to find at the time. As such, she found that the plaintiff’s failure to previously identify the documents was “understandable” and also ruled that the files were indeed relevant. Bard also argued that the public disclosure would reveal their company’s arrangements with suppliers and could damage their ability to compete – a move that plaintiffs counter-argued was simply an attempt to hide the use of restricted materials in their mesh product.

The case continues, with previously redacted documents under renewed scrutiny. One judge noted that they were no longer convinced that portions redacted by Bard were simply a necessary minimum, while still stopping short of accusing the company of the deliberate withholding of pertinent evidence.

For women who continue to suffer from the effects of TVM, it’s another small step on the road to compensation.