The General Accounting Office (GAO) is being asked to investigate the FDA’s process for managing power morcellators. Specifically, the processes being brought into question are those that deal with the FDA’s approval and oversight of these medical devices. Twelve members of Congress have written a letter together and sent it to the GAO calling for this investigation. The basic reason for this request appears to be the fact that the warnings that the FDA did issue regarding these devices came many years after studies began to suggest that these morcellators may pose a danger to patients.
What Are Power Morcellators?
Power morcellators are medical devices that are used in certain types of surgical procedures. These procedures include hysterectomies and the removal of uterine fibroids in women. A power morcellator is in effect a sort of robotic arm that is used by surgeons to perform these surgeries. Power morcellators were seen as advantageous to more traditional forms of these surgeries because of their laparoscopic nature. What that means is that these devices make a very small incision, cut the substances to be removed from the patients into small pieces and remove them one-by-one. This small incision generally leads to a faster recovery time, less pain and suffering and a smaller chance that infections will form around the incision.
What Went Wrong With Power Morcellators?
Unfortunately, studies eventually began to appear that concluded that women who underwent procedures using these devices were more likely to ultimately be diagnosed with cancer. Further analysis indicated that when these small pieces of material were being removed from the body, they were exposed to other regions on their way out. A percentage of these pieces of material were cancerous, unbeknownst to surgeons before the procedures. Therefore, the exposure of cancerous cells to the patients’ bodies made it more likely that they would develop cancerous tumors, some of which may have been deadly.
Why Are These Congress Members Upset?
The twelve members of Congress are unhappy because of the amount of time that lapsed between the publishing of the first of these studies and the warning that was finally issued by the FDA. More than a decade passed between the publishing of multiple studies and the agency warning the public about these potential cancer risks. As such, the legislators are asking the GAO to investigate the situation and find out how and why this could have happened.
Power Morcellator Lawsuits and Your Legal Rights
At this point it is too early to say whether or not the GAO will investigate the FDA. If so, the findings could add evidence to the growing number of power morcellator lawsuits that have already been filed and those that will be filed in the future. If you or someone you love has been harmed by one of these devices, contact the power morcellator lawyers at Parilman & Associates today to schedule a free initial consultation. You can either email the firm or call 800-800-DRUG.