Power Morcellator Approval Questioned
Power morcellators are produced by various companies, and have been approved for surgical use by the Food and Drug Administration. Several recent lawsuits are raising questions about the known risk associated with power morcellators and the ethics of their use in during surgery.
What is a power morcellator?
A power morcellator is a device used during surgery to cut and shred tissue for removal. The medical device consists of a long, hollow tube with cutting jaws. The jaws slice unwanted tissue during surgery, which is then removed via the hollow tube.
Power morcellators are most often used to remove uterine fibroids, or cysts, during surgery. The problem is that doctors are unable to distinguish cancerous cysts from non-cancerous cysts. If the morcellator cannot remove every single cancerous cell from a cyst, there is potential for that cancer to spread and change.
For example: a Michigan woman recently filed a lawsuit against power morcellator manufacturer Karl Storz Endovision, Inc, after undergoing a laparoscopic hysterectomy, during which power morcellators were used to shred fibroid cysts. The woman was later diagnosed with stage 4 cancer, which her lawsuit alleges is the result of the morcellator use.
Lawsuits such as this raise questions about the medical community’s approval of the device. Power morcellators are known to cause upstaging of cancer, turning a treatable Stage 1 ovarian cancer into a terminal Stage 4 cancer affecting other parts of the body. In fact, last year, the FDA issued a warning about the risk of cancer upstaging by power morcellators. In response to this warning, Johnson and Johnson pulled their version of the device from global markets.
It may, however, be a case of too little, too late: “Even though the FDA has flagged morcellators’ risk of spreading undetected cancer, its warning came ‘decades after some studies were already pointing to a serious problem.’” It appears that action on the issue may come sooner rather than later. The U.S. Government Accountability Office (GAO) announced recently that it was beginning an investigation into the FDA’s approval of the device.
While Stage 4 cancer is always terminal, uterine fibroids are not. They can cause severe discomfort, but there are many treatments available that do not carry the risk of a power morcellator.
If you or someone you know has undergone surgery with a power morcellator, you should have a comprehensive physical examination as soon as possible. If you have suffered complications due to surgery or cancer upstaging, you may be entitled to compensation for you medical bills and pain and suffering. Our experienced defective medical device attorneys are here to help you. Please contact Crandall & Pera Law today to reserve a consultation with an experienced medical malpractice attorney. We maintain multiple offices throughout Ohio and Kentucky for your convenience.