After being sued by over 600 women who claim that their transvaginal mesh products caused serious-life altering injuries, Johnson & Johnson's Ethicon unit has decided to stop selling four of its most popular transvaginal mesh products and restrict the usage of other Gynecare mesh products.
In a letter filed on June 04, 2012 with U.S. District Judge Joseph Goodwin, an Ethicon spokesperson asked the Food and Drug Administration to stop "commercializing" the following devices:
- Gynecare Prolift ® Pelvic Floor System
- Gynecare Prolfit + M® Total Pelvic Floor Repair System
- Gynecare Prosima ® Pelvic Floor Repair System
- Gynecare TVT Secure™ System
Newly Restricted Devices
- Gynecare Gynemesh ®PS Nonabsorbale Prolene ® Soft Mesh
Ethicon will continue to sell Gynecare Gynemesh but will change the labeling to restrict its use to only abdominal implantations, likely because research indicates that complications are far less common when mesh implants are implanted abdominally.
Ethicon has requested 120 days to discontinue sales of its products and to give customers, hospitals, and surgeons sufficient time to find alternative products for incontinence and pelvic organ prolapse surgeries. An Ethicon spokesperson states, "Ethicon will also discontinue or revise as appropriate, all marketing materials during this time."
The FDA went on record in March and concluded that J&J/Ethicon has been selling its Gynecare Prolift Pelvic Floor System for three years without prior FDA approval. Ethicon began marketing Gynecare Prolfit mesh in March 2005. Ethicon claimed that the product offered an "innovative and effective surgical option. The FDA first learned of the Gynecare Prolift in 2007 and did not formally clear the Prolift until May 2008.
Afterward, the FDA ordered that J&J and other transvaginal mesh manufactures conduct further studies on the potential complications of transvaginal mesh implants after receiving over 1000 adverse event reports from women all over the United States.
Ethicon/Gynecare products have been linked to the following complications:
- Vaginal mesh erosion (ie. extrusion or protrusion of the mesh out of vaginal tissue)
- Organ (bowel, bladder, blood vessel) Perforation
- Nerve Damage
- Pain, infection, bleeding, and pain during intercourse (dyspareunia)
- Urinary problems
- Recurrent prolapse
- Neuromuscular problems
- Vaginal scarring/shrinkage caused by mesh contraction
- Emotional distress
- Decreased quality of life