(June 23, 2012)
Earlier this month, medical device manufacturer Johnson & Johnson (J&J) announced that it would terminate production and sales of four of its Ethicon pelvic mesh implant systems.
The U.S. Food and Drug Administration (FDA) received a request for approval from J&J to stop the “commercialization” of theses devices. The four transvaginal mesh devices that will be withdrawn are:
- Gynecare TVT Secure System;
- Gynecare Prosima Pelvic Floor Repair System;
- Gynecare Prolife Pelvic Floor Repair System; and
- Gynecare Prolift + M Pelvic Floor Repair System.
Ethicon has also asked the FDA for 120 days to cease commercialization, giving Ethicon sufficient time to let any patients affected by this announcement know of this news. It also gives them time to provide both hospitals and patients enough time to plan for alternative treatments.
This withdrawal is not just in the U.S.; rather, it is a worldwide recall. This shows that the benefits to these transvaginal mesh devices clearly do not outweigh their risks to the patients using them.
Ethicon and J&J are currently faced with hundreds of lawsuits in federal and state courts because of these transvaginal devices. The individuals affected by these poorly designed, dangerous products, allege that Ethicon pelvic mesh implant systems have caused serious injuries, including the product eroding and shrinking, causing pain and injuries after the devices were threaded into place via vaginal incisions.v