June 5, 2012 — Ethicon, Inc., a division of the healthcare company Johnson & Johnson, is asking the U.S. Food and Drug Administration (FDA) for permission to withdraw four of its transvaginal mesh products from the U.S. market. The problematic devices have caused thousands of injuries, and are currently at the heart of a Multidistrict Litigation (MDL) in U.S. District Court involving around 600 lawsuits. Women injured by the devices claim that the company sold dangerous products that caused severe side effects — including vaginal damage, scarring, chronic pain, infection, and more.
They are not announcing a recall of devices already implanted in women.
Company officials from Johnson & Johnson asked for permission to stop “commercializing” the following four products:
- Gynecare Prolift
- Prolift+ M
- TVT Secur
The FDA has not yet given the company permission to stop selling the four products. However, Johnson & Johnson is already planning on phasing out the devices by the first quarter of 2013. They also plan on advising doctors that they should use another type of treatment for their patients.
The transvaginal mesh products have been a source of great controversy over the last few years. One issue stemmed from Ethicon’s Gynecare Prolift, which was initially sold in 2005, and then sold for another three years without any FDA notification or approval. The company claimed that the Gynecare Prolift was legal because it was “substantially similar” to existing vaginal mesh products.
Unfortunately, the “substantially similar” device was Boston Scientific Corp.’s ProteGen, which was recalled more than a decade ago due to safety complaints.
Recently, public advocates sought to close this loophole (allowing the approval of “similar” devices based on products recalled for safety issues) in an overhaul legislation that would expedite the FDA approval process and increase fees from drug and device companies. The clause was removed from the final legislation, which quickly passed through the House and Senate.
The FDA has recently moved to reclassify all transvaginal mesh products as Class III devices, which would force manufacturers to conduct safety studies and submit new approval applications before selling any more transvaginal mesh products in the future.
However, the future of these devices is looking bleak. Much of the injuries stem from the way the products are implanted — through the vagina — which increases the risk of infection, severe scarring that decreases quality of life, and difficulty with placement that increases the risk that the device will erode into the vagina, perforate internal organs, and cause other severe injuries.
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