According to company emails that recently became public, executives with Ethicon, a division of pharmaceutical company Johnson & Johnson, concocted a coverup for its Gynecare TVT blue transvaginal mesh.
“The behavior that comes to light is very suspect, and these companies deserve to be reprimanded for their behavior that obstructs complete discovery of the facts at hand,” commented Daniel Nigh, a vaginal mesh lawyer with the Levin, Papantonio law firm. “Mesh can deteriorate internal organs, causing the patient excruciating pain.”
The email outlines the product’s defects and two separate complaints about “allegedly brittle mesh.” When Gynecare’s Research and Development department became aware of the blue mesh’s defects, Daniel Smith of Gynecare R&D informed other executives and Johnson & Johnson officials that “this is not new, and was exactly the original issue that stopped TVT blue for months.”
Smith discusses the importance of launching a “major damage control offensive” because the problem of defective and dangerous mesh is “not going away anytime soon and competition will have a field day.” He urged that the “damage control offensive” should inform the surgeons “upfront” that they will “see BLUE shit and it is OK.” The “blue shit” alludes to the blue mesh breaking off into small pieces inside of the woman’s vagina.
Bernhard Fischer of Gynecare Marketing described two separate, but similar, incidents when, after implanting the blue mesh into two patients, small, blue particles kept falling off (sic) the mesh. Dr. Mirna, the doctor who reported the defect and teacher at an Austria-based TVT training center, described the mesh as “brittle.”
“Since our mesh is now blue,” said Fischer, “would it be possible that this was always the case but now it is simply visible as opposed to before the introduction of TVT Blue?”
If the clear and blue mesh were made of the exact same material and similarly produced, then similar occurrences with the clear mesh seem feasible.
What’s most alarming about the email exchange is that Smith exclaimed that this situation “is why [he] wanted to launch TVTO in clear!!!!!” It’s alarming because, as mentioned by Fischer, it could be possible that “brittle” mesh was always an issue, but the new, blue coloring just made it visible.
Should a coverup be the case, then the emails just further outline the outright disregard and carelessness exhibited by the pharmaceutical industry. This adds to the “profit over safety” mantra that has been adopted and practiced by big pharma for years.