J&J Sold Transvaginal Mesh After FDA Ordered Halt
Johnson & Johnson sold transvaginal mesh implants for nine months after it was ordered by the Food and Drug Administration (FDA) to halt sales of the devices.
In a 2007 letter, the FDA told the company to stop Gynecare Prolift sales until the agency determined if the device was “substantially equivalent” to other medical devices, according to Bloomberg. The agency cited the “potential high risk for organ perforation” when surgeons insert the transvaginal mesh.
Transvaginal meshes are implantable devices made for the treatment of pelvic organ prolapsed (POP) and incontinence by Johnson & Johnson and other manufacturers.
The August 2007 letter was among documents made public as part of transvaginal mesh litigation in New Jersey state court, according to Bloomberg.
Johnson & Johnson began selling the Prolift device in 2005 but failed to re-apply for approval because it determined its device was similar enough to a product - Gynemesh - already approved by the FDA. Johnson & Johnson relied on FDA guidance for when new applications must be submitted by a manufacturer. However, the agency decided a new application was needed in 2007, according to Bloomberg.
In May 2008, the FDA approved the mesh device after nine months of negotiations with Johnson &Johnson’s Ethicon unit. The FDA did not sanction the company for failing to comply with its earlier order.
Johnson & Johnson currently faces more than 1,400 pending transvaginal mesh lawsuits by women claiming the device caused injuries such as nerve damage and debilitating pain.
If you or a loved one has been harmed by a transvaginal mesh device, or another unsafe medical device, contact Sokolove Law for a free legal consultation. For legal help, call (800) 581-6358.