Johnson & Johnson is in hot water yet again for their relationship with federal regulators over their problematic vaginal mesh devices. According to Bloomberg, Johnson & Johnson sold one of their vaginal mesh implants for nine months after being told by the U.S. Food and Drug Administration (FDA) to cease advertising in August, 2007. The letter to J&J stated: “You may not market this device until you have provided adequate information” on 16 potential deficiencies. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.” J&J reportedly continued to sell the device, but was cleared to sell the mesh in 2008 without being issued sanctions by the FDA.
This realization comes just soon after it was revealed that J&J released one of its vaginal mesh devices three years before it was approved.
This realization comes just soon after it was revealed that J&J released one of its vaginal mesh devices three years before it was approved. J&J’s Ethicon unit released the Gynecare Prolift vaginal implant in March, 2005, but it was not approved until May, 2008. The company invoked a process called 510(k), in which products can be released without approval if they are extremely similar to products already released. The FDA said that did not apply in this case, concluding that marketing and sale of the product began “without appropriate” clearance.
J&J recently announced that it will halt sales of the Gynecare Prolift Pelvic Floor Repair System, Prolift MTM, TVT Secur, and Prosima vaginal mesh systems, but has asked to continue sales of the Gyencare Gynemesh. Thus far, Johnson & Johnson faces over 1,400 lawsuits alleging severe physical damages due to use of the vaginal mesh. The FDA announced last summer that vaginal mesh implants have not been proven any more effective than alternative non-mesh procedures, and ordered manufacturers to study further the possible adverse effects of the devices.
Though transvaginal mesh was used to treat pelvic organ prolapse (POP), the adverse effects of the implants has been known to cause more problems than they help. Transvaginal mesh is known to commonly cause stress urinary incontinence (SUI) due to pressure on the bladder, as well as general pain and discomfort, mesh erosion through the vagina, infection, urinating problems, organ perforation, bleeding, interference and pain with sexual intercourse, and mental anguish.
Some women that have had transvaginal mesh inserted have required revision surgeries, prolonged hospitalization, and lifelong injuries as a result of use of this device. If you have had a vaginal mesh implant and have experienced adverse complications, you may be eligible to participate in a lawsuit against Johnson & Johnson. Victims of vaginal mesh problems may be entitled to compensation for medical bills (past, present, and future), lost wages, pain and suffering, and possibly punitive damages.