Personal injury attorneys have filed more than 550 lawsuits on behalf of women claiming that Johnson & Johnson’s vaginal mesh implant, Gynecare Prolift, is responsible for their injuries. Gynecare Prolift, manufactured by Johnson and Johnson’s Ethicon, and other vaginal mesh devices, is used to treat incontinence or help women with pelvic organ prolapse, a condition in which weakened muscles fail to support internal organs.
Johnson & Johnson began marketing the device in March 2005. However, the company did not seek approval by the Food and Drug Administration until 2007 when Johnson & Johnson sought approval for a related product. Neither device was approved for use by the FDA until May 2008. By that time, 123 complaints of serious injuries as a result of use of the Prolift vaginal mesh had already been received by the FDA.
The FDA is rejecting Johnson & Johnson’s assertion that Ethicon’s vaginal mesh Prolift did not require FDA approval because it was so similar to an already approved device, the Gynecare Gynemesh. The FDA cleared the Gynemesh in January 2002 for the repair of hernia and other defects with connective tissue. Both devices are made of the same nonabsorbable polymer; however Ethicon included an application kit to help surgeons implant the Prolift device.
In July, the FDA reported that deaths, injuries, or malfunctions related to vaginal mesh for prolapsed organs had increased five times over. Following the report, an advisory panel urged the FDA to reclassify vaginal mesh implants as “high-risk” devices that require human testing.
The FDA demanded that Johnson & Johnson and other manufacturers of the mesh devices study organ damage and complications related to the products earlier this year.
In the past two years, three of Johnson and Johnson’s subsidiary companies have pleaded guilty to bribery or illegal marketing of drugs. A fourth unit has also agreed to plead guilty in a marketing case.
Johnson and Johnson has also recalled a number of artificial hip implants and over-the-counter drugs in the past few years. The mesh lawsuits blaming Johnson & Johnson for injuries are currently pending in state court in New Jersey.
The Philadelphia personal injury attorneys at Messa & Associates are experienced at handling cases involving pharmaceutical and medical device injuries. Our extremely skilled team of personal injury attorneys and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you have been injured by a defective medical device, a negligent medical provider, or have endured any other type of personal injury, contact the personal injury attorneys of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.