Judge Orders Release of Ethicon's Post-Marketing Safety Data
Eric ChaffinSeptember 20, 2012 10:47 AM
A few months ago, Judge Carol E. Higbee, who is overseeing the consolidated Ethicon vaginal mesh lawsuits in New Jersey Superior Court, scheduled the first bellwether trials to begin in November 2012.
Now, Judge Higbee has ordered Ethicon, a subsidiary of Johnson & Johnson, to release post-marketing safety data and FDA correspondence related to its mesh products. The data is likely to include safety information the FDA requested in January 2012 from 30 transvaginal mesh device manufacturers. The FDA asked for 3 years of data on the safety and effectiveness of various mesh products.
New Data of Interest to Vaginal Mesh Lawyers
Vaginal mesh lawyers are expected to review the newly released safety data on Ethicon’s products. The information may reveal key information about how the company brought its products to market, and about how much it knew about serious safety risks and complications.
Vaginal mesh may be used in the treatment of pelvic organ prolapse. This exists when a woman’s pelvic muscles become overly stretched and weakened due to multiple childbirths, surgery, or aging. The muscles may allow the bladder, uterus, or bowel to drop or fall into the vaginal wall because they are not able to adequately support pelvic organs. This may cause symptoms like pressure and urinary incontinence.
Gynecare mesh and similar mesh products were designed to provide support and help pelvic organs back into their original position. This helps to reduce urinary incontinence and other symptoms. Post-marketing reports, however, indicate that women are experiencing more pain and discomfort than prior to the surgery.
On July 13, 2011, the FDA released a safety communication noting that complications from transvaginal mesh repair for pelvic organ prolapse are not rare. The FDA also noted that even multiple corrective surgeries may not fully correct problems like erosion and infection. Other side effects may include organ perforation, bleeding, continued urinary problems, painful sexual intercourse, mesh extrusion, and recurrence of pelvic organ prolapse.
Currently, thousands of women are involved in transvaginal mesh lawsuits around the country. In addition to products made by Ethicon, other manufacturers named as defendants include American Medical Systems, C. R. Bard, Boston Scientific, and Coloplast.
Johnson & Johnson Pulls Four Gynecare Products from Market
With over 600 vaginal mesh lawsuits currently pending in state and federal courts, Johnson & Johnson and Ethicon have stopped selling four vaginal mesh implants. In correspondence filed June 4, 2012, the companies told Judge Joseph R. Goodwin, who is overseeing the current vaginal mesh MDL in the U.S. District Court in West Virginia, that they would cease commercializing the four products and plan to phase them out completely by early 2013.
Products included in the phase-out include:
Gynecare TVT Secur
Gynecare Prosima Pelvic Floor Repair System
Gynecare Prolift Pelvic Floor Repair System
Gynecare Prolift MTM Pelvic Floor Repair System
Despite this move, the companies will still be expected to release safety data regarding these four products for the New Jersey litigation.
The Gynecare Prolift device was the subject of an earlier controversy, when documents released from a New Jersey lawsuit revealed that Johnson & Johnson continued to sell the mesh even after the FDA directed the company to halt sales because the device lacked the appropriate clearance.