An interview with Ann Becker Schutte, Ph.D Last year, for the first time, I attended Stanford...READ MORE
Strike 1, 2, 3 Times You’re Out?
In 1999 Boston Scientifics’ ProtoGen sling was recalled from the market, though Boston Scientific tried everything in their power to stop it. Boston Scientific hid over 400 complaints from the FDA, concealing the cases of erosion, extrusion, infection and pain. Surgeons in the American Journal of Obstetrics and Gynecology discussed how the ProtoGen sling was “rushed to market for financial reasons without adequate premarket clinical trials.” One would think that after this high profile and embarrassing debacle, after their sling was recalled from the market, that Boston Scientific and others would take a hint. Perhaps trials should be undertaken before releasing a new product to market; perhaps claims of injury should be taken seriously. Perhaps pharmaceutical companies should put consumer safety right up there with profit in terms of company-wide importance. Perhaps – yet no lesson was learned in 1999. Instead, the ProtoGen sling encouraged a whole new line of medical devices that were just as dangerous.
This wasn’t the first time that a medical device intended and manufactured for the same purpose as the ProtoGen showed signs of significant injury. In 1933 First Lady Eleanor Roosevelt included a “womb supporter” in her 1933 exhibit, “America’s Chamber of Horrors” – an exhibit that first put women’s consumer safety on the map. In the 1800s “womb supporters” were well known to cause pain and be difficult for surgeons to remove – just as they are known today. In fact the most telling piece of information may come from the surgeons who have such difficulty removing the faulty devices themselves. These surgeons say that the Protogen, the “womb supporters” and the Transvaginal Mesh devices of today all go against the basic principles of surgery:
Beware of Contamination; Do Not Implant Medical Devices That Are More Prone To Contamination.
You know that song your dad used to sing at the ballpark, “Strike one, two, three times you’re out!” Unfortunately, pharmaceutical companies don’t play by the same rules of our favorite team. And that’s why we’re here.
Transvaginal Mesh is not known to cause erosion, extrusion and pain only sometimes; it is a not a rare risk that we are talking about here. Instead, the dangerous consequences that come from Transvaginal Mesh implantations come often – and it is expensive, and time consuming and very, very painful. After so many countless visits to the doctor, after the surgeon has to do one revision surgery to remove the device, two revision surgeries to remove the device, three, it can feel like you have no hope. By undergoing that implantation of transvaginal mesh, you think, maybe you unknowingly signed away the keys to the life you used to know. Maybe the pain is normal now. Maybe it will always be here.
The transvaginal mesh lawsuit is the way to fight back, really the only way to fight back against the pharmaceutical companies. As you can see, the claims and reports don’t do as much as we’d like to move towards a safer tomorrow. But our transvaginal mesh lawyers can fight back; and with that one, two, three strikes you’re out! spirit, we can win.