Defective Medical Products Comments Off
Johnson & Johnson and its subsidiary, Ethicon, are facing their first legal trial in a consolidated proceeding in Atlantic County in New Jersey. The proceeding is one of the 1,800 lawsuits that Johnson & Johnson and Ethicon currently face due to the failure to disclose some of the dangerous risks in the label of its transvaginal mesh product, Prolift.
Prolift was introduced to the market in 2005 after it received the approval of the U.S. Food and Drug Administration through the fast-track approval system. The transvaginal mesh was claimed to be similar to Gynecare so that it could bypass the additional testing required for the approval to market the drug.
However, it was not until March 2012 that the FDA released a communication confirming that the Prolift was initially marketed without any clearance or approval, that tests should have been done to determine its readiness for the market, and that it had been illegally marketed to the consumers, risking their health and well-being.
Prolift is used for the treatment of women who have pelvic organ prolapse (POP) and/or stress urinary incontinence. Pelvic organ prolapse is a condition wherein the pelvic organ drops and presses against the vaginal wall. The mesh product works by keeping the organs in place. The problem arises when the mesh product disintegrates or contracts.
Some women complain about pain especially during sexual intercourse. There are other complications that are potentially linked to the use of Prolift, which is why lawsuits have been filed alleging the lack of proper safeguards on the part of Johnson & Johnson and Ethicon to ensure patient safety.
If you want to have your Prolift case evaluated, you may contact our Prolift lawyers at our toll-free number, 1-800-992-6878.
d’Oliveira & Associates 2540 Pawtucket Ave, East Providence, RI 02914 (401) 431-1990