Pharmaceuticals giant Johnson & Johnson now faces increasing legal troubles in Australia caused by the failures of its transvaginal mesh devices.
According to Australia’s ABC News, women there have begun joining a class-action lawsuit against the American company after they suffered serious injuries and complications caused by transvaginal mesh devices. These mesh products are implanted into a woman’s body to help alleviate conditions caused by Pelvic Organ Prolapse and Stress Urinary Incontinence.
Like thousands of women around the world, Australians believe these transvaginal mesh products were approved without any pre-market safety testing, just purely based on the idea that they were mirrors of other surgical mesh products that have proven to be effective in other procedures. The same results have not materialized for women who’ve received a transvaginal mesh product, however.
Instead, erosion of the mesh through the vaginal walls or through layers of skin seem to be the chief complaint of transvaginal mesh recipients. When this defect occurs, it can cause severe pain and inflammation, making ordinary life very difficult. Some women, according to numerous previous reports, say their defective transvaginal mesh products have essentially incapacitated them, making walking, sitting, or standing difficult and painful. Other complications caused by defective transvaginal mesh include vaginal erosion, infection, extrusion, perforation, chronic pain, and abscess.
As is the case in the U.S., where many believe the Food and Drug Administration’s maligned 510(k) “fast-track” approval system wrongly allowed many transvaginal mesh devices onto the market without requiring them to undergo much, if any, pre-market testing for safety or effectiveness, Australians are just as skeptical of their Therapeutic Goods Administration (TGA), which made a similar move a few years ago to approve these products.
Unlike in the U.S., where the FDA has since backed off its widespread approval of transvaginal mesh devices and recently issued a warning against their use in surgeries, the Australian TGA has not taken those steps. In 2010, according to the same report, the TGA said it conducted a review of the adverse event reports associated with the use of transvaginal mesh devices and found no reason to make such a warning there. Just last week, the U.S. FDA heard from an advisory panel it convened that believes transvaginal mesh devices should be re-classified to indicate they’re among the most dangerous available and that their use carries a significant risk of serious injuries and complications.
But as is the case domestically, the TGA’s own fast-track system is being blamed for allowing numerous medical devices onto the market, specifically from Johnson & Johnson, that have resulted in thousands of adverse event reports. Among them are transvaginal mesh devices, metal-on-metal hip implants, and breast implants.
More women in the U.S. are opting to join a growing Multidistrict Litigation against Johnson & Johnson filed in a West Virginia federal courtroom. Dozens of manufacturers of transvaginal mesh devices also face similar legal actions. Women who’ve suffered these and other side effects of a defective transvaginal mesh device say they’ve incurred mounting medical bills and have not found much relief from revision surgeries that have failed to remove the entire defective device after it has broken apart after being implanted.
In response to the growing criticism of its line of transvaginal mesh devices, Johnson & Johnson recently announced that it has stopped manufacturing and marketing its Prolift, Prolift + M, TVT Secur, and Prosima products.