In the last decade, as many as 20,000 women in Australia have received transvaginal mesh devices to repair pelvic organ prolapse and stress urinary incontinence. Now, as doctors and researchers find the mesh products are associated with a high rate of complications, some law experts Down Under believe they could be the subject of the largest product-injury class action lawsuit in Australian history.
“This prolapse mesh class action that we’ve commenced in the Federal Court … has the potential to be the biggest product class action that Australia has ever seen,” Australian attorney Rebecca Jancauskas told the Australian Broadcasting Company. Ms. Jancauskas is representing the lead plaintiff in an Australian class action suit filed against Johnson & Johnson, which announced earlier this year it would cease making transvaginal mesh products.
The transvaginal mesh lawsuit is the third class action Johnson & Johnson faces in Australia in as many years. The medical giant is also being sued by plaintiffs who claim they were injured by defective metal hip implant devices made by subsidiary company DePuy Orthopedics.
As in the U.S., many Australian patients allegedly injured by Johnson & Johnson’s transvaginal mesh products and its all-metal hip implants say that the devices weren’t adequately tested before being implanted in tens of thousands of people. Neither of the products underwent pre-market safety trials because regulatory bodies in both countries have a relaxed approval process for medical devices that are similar to already approved devices.
Add to this lack of testing and rush to market a potentially defective product design, and the results can be devastating for some patients.
Julie Davis, one of the thousands of Australian women implanted with transvaginal mesh who are now suing Johnson & Johnson, told the Australian Broadcasting Company (ABC) that the transvaginal mesh surgery was “way more traumatic and devastating” than she had ever imagined. Ms. Davis was implanted with the mesh to correct a severe case of prolapse, but instead of improving her condition, she says the mesh ruined the quality of life she and her family once enjoyed.
The mesh, which her doctor said had the effect of a cheese grater on surrounding organs, had worn a hole through the vaginal wall, causing intense and inconsolable pain. Ms. Davis had to rely on a motorized scooter to get around because it was too painful to walk. She told ABC that sexual intercourse with her husband also became impossible and that the family business suffered as a result of her injuries. Removing the implanted mesh required Ms. Davis to undergo five surgeries over four years’ time.
According to the U.S. Food and Drug Administration (FDA), “Mesh-associated complications are not rare.” In July 2011, the agency issued a safety advisory, warning that “Based on data from 110 studies including 11,785 women, approximately 10 percent of women undergoing transvaginal POP repair with mesh experienced mesh erosion within 12 months of surgery.”
In the U.S., transvaginal mesh products are now the subject of hundreds of lawsuits, which have been consolidated into four Multidistrict Litigations (MDLs) against mesh manufacturers C.R. Bard, American Medical Systems, Boston Scientific, and Johnson & Johnson’s Ethicon. The transvaginal mesh MDLs are pending in U.S. District Court for the Southern District of West Virginia.