Apparently, once a medical device gets approved by the FDA to go on the market, it is almost impossible to take it back off, even if the device has proven to be dangerous or even deadly, according to Michael Carome from the public watchdog group Public Citizen. In fact, the FDA has only withdrawn a total of two products from the market, ever.
This incomprehensible situation is proving injurious and even fatal for some women. One group of these women, known as E-Sisters, are women who have been implanted with the permanent contraceptive device called Essure. In 2017 alone, the FDA received 12,000 reports of adverse effects from women with Essure, ranging from bleeding, bloating, and pelvic pain to rashes, tooth loss, joint pain and fatigue associated with an allergic or autoimmune reaction. Madris Tomes, a former FDA analyst, tracked more than 26,000 total adverse reports about Essure, including eight deaths. In addition, there may be as many as 32,000 more complaints made to the manufacturer of Essure that were never officially reported to the FDA.
Shortly after Essure went on the market, independent research began challenging the safety and efficacy of the device. One study found that women who had Essure needed follow-up surgery ten times as often as women who had their tubes tied. And the surgery to fix the problem is not a simple one. In fact most surgeons recommend a hysterectomy as the best way to remove Essure.
But The FDA continues to say they are evaluating Essure’s “risks and benefits”. In the meantime, despite meeting with a group of E-Sisters asking that Essure be banned, Scott Gottlieb, the FDA Commissioner, says that the device will remain on the market. Suspiciously, Bayer has pulled Essure from every other market, leaving the U.S as the only country in the world where Essure is still available. It seems that, in the absence of any real government regulation here, women will have to sue the manufacturer to convince them to remove this device from the market.
The same holds true for pelvic mesh. This potentially dangerous device claims to fix urinary incontinence or pelvic organ prolapse. The problem is that, in ten percent of cases where mesh is used for prolapse, the mesh works its way into the surface of the vagina or another organ, causing intense pain. In fact, so many women have been hurt by this device that 100,000 of them have sued mesh manufacturers.
Yet, pelvic mesh is still being used for female incontinence. In 2008, the FDA simply issued a “public health notification” about transvaginal mesh instead of banning the device. What is especially galling is that this product was approved by the FDA without a single clinical trial, in a process where a manufacturer only has to prove that the device is “substantially equivalent’ to another previously approved device.
Now, instead of protecting women from potentially harmful products, the FDA, with Gottlieb’s encouragement, has been pushing to streamline the approval process and bring more products to the market. Why?
The answer may be that the FDA has too close a relationship with the pharmaceutical industry and its money. According to the Project on Government Oversight, the FDA relies on pharmaceutical company fees for more than half of its funding. Add in the fact that there appears to be a revolving door between employees at the FDA and the pharmaceutical industry, and you do not have any incentive to regulate the industry.
When the FDA Commissioner himself comes straight from board memberships and consultancies with various pharmaceutical companies, the agency is basically telling the industry it is open for business. It should then come as no surprise that the decisions made by the FDA fall squarely on the side of the pharmaceutical companies and their devices and not on the side of women who are sick or dying.
The Collins Law Firm represents individuals who have been harmed by defective products like Essure and pelvic mesh. If you feel your health has been impacted by one of these medical devices, call one of our experienced attorneys for a free consultation at (630) 527-1595.