Vaginal Mesh Product Still Available Amidst Lawsuits Concerns
Currently, Johnson & Johnson is facing hundreds of lawsuits by women who allege they have been seriously injured by vaginal mesh implants made by the corporation. The company, one of the world’s largest health manufacturers of health products, was able to keep the mesh products on the market regardless of potential safety issues due to a highly criticized part of the U.S. Food and Drug Administration’s (FDA) approval process. The process glitch exists in a loophole that stipulates that if a product, or prototype, has been previously approved by the FDA then other comparable products require a lesser degree of safety testing, as reported by Bloomberg News.
However, amidst a plethora of headlines regarding defective and dangerous medical recalls and lawsuits, physicians, government officials, and the general public are pressuring the FDA for alterations on the antiquated system. In the instance of vaginal mesh, the agency kept passing the implants manufactured and sold by Johnson & Johnson with little to no testing, based on the product’s comparability to the ProteGen formerly made by Boston Scientific Corp which was removed from the market for safety issues. In lawsuits, affected women report continual pain and bodily harm from the products and in some cases multitudes of medical operations in attempt to correct resulting damages.
The Transvaginal Mesh products are used by women to treat pelvic organ prolapse as well as incontinence. While the FDA claims it cannot accurately estimate the amount of women with the implants since their first availability in 1998, it claims approximately 300,000 were utilized in 2010 alone. Last month, a panel of physicians (mostly pelvic surgeons) advised the FDA that the products should be re-listed as high risk and tested more in order to remain on the market.
Even though the FDA seems to be moving toward that decision, according to Bloomberg, its director said it could take as many as three years to implement the new standards, and until then, the products in question will remain available to the public. If you or a loved one has been injured by vaginal mesh implants in Pennsylvania, contact the transvaginal surgical mesh attorneys in Pennsylvania with Anapol Schwartz at (866) 735-2792.
