In its June 4th announcement that it is taking four synthetic vaginal meshes off the market, Ethicon acts like it is in charge of the FDA.
First, the division of Johnson & Johnson (J&J) requests it be given 120 days to “cease commercialization” which essentially means allowing the four defective medical devices to remain on the shelf until supplies are exhausted.
And Ethicon has requested that the FDA’s mandate to provide post market studies, also known as a 522 order be “placed on hold.”
So Ethicon is essentially asking to be allowed to continue to profit from a defective mesh but to be released from accountability by not following the authority of the FDA which last January ordered Ethicon and 30 other mesh manufacturers to conduct expensive, three year post-market clinical studies to determine safety and efficacy.
That’s a nice deal if you can get it, but is the dog wagging the tail or is the tail wagging the dog?
What was the FDA asking for?
The FDA can order a 522 study when a medical device has the potential for serious injury and is intended to be implanted in the body for more than one year. When the FDA orders postmarket surveillance, the manufacturer must submit a plan to conduct the surveillance.
In this case, the plan was to answer some of the following questions:
- What proportion of women undergoing transvaginal pelvic organ prolapse surgery is exposed to this device and what sort of surgical procedures are performed?
- What are the rates over 36 months of: mesh exposure into the vagina, mesh erosion into another organ, pelvic pain, infection, dyspareunia (painful sex), vaginal shortening, scarring, bleeding, fistula formation, neuromuscular problems, revision surgery and recurrence?
- What is the quality of life for women who have received this device?
- Is the rate of effectiveness different among women with and without mesh?
This is just a small sample of the many questions all of the mesh manufacturers have been asked to provide at the six month, 12 month, 18 month, 24 month and 36 month mark.
A study of this kind can easily run well into the seven figures and Johnson & Johnson’s Ethicon Gynecare division is the biggest maker of these devices.
Ethicon was ordered to submit its plan to conduct post-market surveillance within 30 days of the receipt of the January letter. As of June 1, no plan has been submitted by Ethicon.
Don’t the rules apply to them?
Here is where the FDA can show some authority, or not, by denying Ethicon’s request to be let off the hook and forcing the company to prove the safety and efficacy of transvaginal mesh.
The estimated 75,000 women who had a transvaginal mesh implant over the last year deserve that much.