Many mothers had no idea that their lives would change—some irreparably—following a "straightforward" surgery to correct pelvic organ prolapse (POP), a common complication of childbirth causing surrounding organs to bulge or sag into the vagina, putting pressure on the bladder and often inducing stress urinary incontinence (SUI). TVM (also called TVT) has been called a "catastrophic failure" of regulators and the health system to protect women. Many women who have undergone POP surgery using this device have developed acute, crippling pain that is often not taken seriously by their doctors, or worse, many doctors and manufacturer executives have turned female pain into the punchline of inappropriate jokes. Women are uniquely impacted by the attitudes towards pain management in healthcare, and due to the implant’s astronomical failure rate (roughly 1 in every 15 procedures) must become proactive advocates for themselves.
It’s tricky to estimate how many women worldwide have been affected by TVM failure. With litigation ongoing in the U.S., the U.K., and Australia, Johnson & Johnson—whose subsidiary Ethicon manufactured many products now recalled or with pending litigation—has declined to provide exact figures of how many women received the implants. What we do know for sure is that the number is in the hundreds of thousands, and that the failure rate is about 1 in 15. Digital records from the NHS show that from 2006 to 2016, over 75,000 U.K. women were fitted for these products, and over that same period of time, over 4,900 subsequent surgeries were performed to correct or remove the failed product—roughly 6.5%.
As if these figures weren’t bad enough, the persistent pain and ongoing need for corrective surgery is compounded by both the cavalier attitude to the suffering of a consumer demographic that is primarily, if not exclusively, female. Many TVM patients report dismissive attitudes from their doctors when they initially bring up the issue of their pain, with many doctors treating it skeptically, making TVM patients “prove” the authenticity of their pain. Making the matter worse, both doctors and Johnson & Johnson executives have turned the victims of this colossal failure—which legal experts have called “worse than Thalidomide”—into the punchlines of inappropriate jokes. Doctors have suggested inappropriate and insensitive alternatives to women whose sex lives have suffered due to the excruciating vaginal pain caused by device failure, making a woman’s inability to enjoy a normal sex life following TVM failure into a joke at her own expense. Meanwhile, Johnson & Johnson execs have presented PowerPoint presentations featuring lingerie-clad models with off-color captions and sent internal emails likening intercourse with a patient whose mesh had failed to “...screwing a wire brush.”
Despite these deeply demoralizing figures, there’s hope for women who’ve been affected by this faulty product. In 2017, U.S. plaintiff Ella Ebaugh was awarded $57 million in damages in a Philadelphia court. The ruling was based on the fact that Ebaugh’s TVM product was launched without a clinical trial, and had been marketed despite the company’s knowledge that the product had a much higher failure rate than comparable products. An internal email thread from Johnson & Johnson complains of “...constant spinning of data” and the company’s dangerous blurring of the “...lines between commercial and research” divisions. Though Johnson & Johnson plans to appeal the verdict, in an unfolding scandal where the victims of defective vaginal mesh are re-victimized by insensitive doctors and money-hungry corporations, this initial victory bolsters the morale of plaintiffs who want Johnson & Johnson held accountable for the damage and pain they’ve caused.
