Johnson & Johnson, the second biggest healthcare products maker in the world, is taking heat and facing lawsuits in connection with their vaginal mesh product, Gynecare Prolift. The mesh, used to treat incontinence or pelvic organ prolapse in women, was put on the market in March 2005, but wasn't approved by the Food and Drug Administration (FDA) until May of 2008. Johnson & Johnson excuses their behavior by stating that they were not required to get approval from the FDA because the Prolift was similar to another product they make that was already approved by the FDA for use in humans. Although the Prolift is made of the same material as the previously-approved Gynemesh, it has a different use and therefore should have been reviewed by the FDA prior to its release to the market. Gynemesh was made to help treat hernias and other defects with connective tissue. Prolift is used for entirely different purposes like the treatment of pelvic organ prolapse.
An FDA report in July 2011 found deaths, injuries and malfunctions tied to vaginal mesh for prolapsed organs increased fivefold. Findings from that report lead to an advisory panel to urge the FDA to reclassify such mesh products as "high-risk". There are several class-action suits pending against companies who manufacture similar devices and products. This newest problem for Johnson & Johnson comes after the company has endured recalls of hip implants and over-the-counter medications.
Comments are closed.