It is so interesting to delve into how a corporation thinks. Not in that they think like a person – even though the U.S. Supreme Court recently gave corporations First Amendment rights – but in that they groupthink.
Take the case of transvaginal mesh. A trial is underway in Superior Court in Atlantic City, New Jersey. Plaintiff, Linda Gross, 47, had the Prolift mesh implanted in July 2006. Almost immediately she had problems and has had nearly 20 operations since to try and fix what the migrating mesh did to destroy her pelvic region. Her doctor says she is permanently disabled. She must self-catheterize just to urinate up to four times a day and has a pain pump permanently implanted.
Johnson & Johnson made the Prolift mesh. Its Ethicon division makes many transvaginal meshes, even though last June it pulled the Prolift mesh from the market without calling it a recall. One of America’s best known makers of a range of consumer products, the trial is giving us an up close and personal look at the inner workings of Johnson & Johnson prior to its Prolift product launch.
The Prolift was scheduled to be marketed in March 2005. Marketing, Research & Development, Engineering, Design Control, Regulatory Affairs and the Medical Director were involved. The Medical Director for Ethicon WorldWide had been plucked from an obscure women’s clinic in Kissimmee, Florida and elevated to a decision-making position. She was not even a urogynecologist but an Ob-Gyn.
Internal company documents indicated the company was in a hurry. “Product Features Will Justify a Premium Price As Compared to GYNEMESH PS Sheets” says one company document. “Multiple Kits Will Be Required To Fully Exploit Market” says another. And the group was very mindful that competitors were right behind.
Even the fact that their own researchers in France suggested the Gynemesh be replaced with a different, safer mesh two months before the Prolift launch went unheeded.
What never made it to the product label was a study on the safety of transvaginal mesh. A retrospective study of 684 patients by French researchers showed a complication rate of 33.6%. And that was at the six month mark. The upper limit of complications Ethicon had established was 20%, so this number far exceeded what the company said would be far too many problems. Physicians, the end users of a device, were not given that information before they implanted the mesh in their patients.
The mesh was never tested on humans, only on cadavers, and the group never studied how to remove the mesh in the event of complications, which it knew would happen according to the deposition of the Medical Director under oath.
Clearly marketing and sales drove the train to the March 2005 launch date, not patient safety.
And, despite a projection date for U.S. Food and Drug Administration approval through the 510(k) notification process, a relatively easy fast-track exchange of paperwork, Ethicon just sold the device with no notice at all – until it got caught.
The company stopped selling the Prolift last June, right after the FDA asked it and 30 other mesh manufacturers to begin studying complications in users.
In New Jersey alone there are 2,000 women waiting to have their day in court because they had a Prolift mesh that eroded, caused pudendal nerve damage, hemorrhaging, fistula formation, infection, and chronic pain, among other complications.Hi
They are watching the proceedings with great interest.