Feds to Probe FDA’s Power Morcellator Approval
The United States Government Accountability Office (GAO) announced recently that it will begin an investigation into the Food and Drug Administration’s approval of power morcellators for use during surgery. Power morcellators are used to cut and shred tissue for removal during minimally invasive surgeries. The device consists of a hollow suction tube with cutting jaws on the end. They are most often used to remove masses of tissue that are unwanted. These unwanted tissues have a higher potential to be cancerous in nature.
Who is at risk?
Anyone who is undergoing laparoscopic or robotic surgery to have tumors or cysts removed is at risk. In particular, women who are undergoing a myomectomy or hysterectomy are at high risk. These procedures carry a higher risk because they are more common, and it is more likely that uterine fibroids are precancerous or cancerous in nature.
Fierce Medical Devices reports that “… 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.’”
A rash of recent lawsuits has alleged that power morcellators are responsible for what is known as “upstaging” cancer. Women with precancerous or Stage 1 cysts suddenly found themselves diagnosed with terminal Stage 4 cancer in another part of their body after surgery with a power morcellator.
The mechanism of this cancer upstaging appears to be that power morcellators do not effectively remove all of the tissue that they cut and shred. This allows single- or multiple-cell clusters to float freely throughout the body, causing significant problems wherever they land.
The FDA issued a warning last year about the risk of cancer upstaging by power morcellators. In response to the warning, Johnson & Johnson, a major manufacturer of power morcellators, pulled the product from use worldwide.
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 South Carolina defective medical device attorneys are here to help you. Please contact McGowan. Hood & Felder, LLC today for a free consultation.
Randy is the former President of the South Carolina Association for Justice. He has been certified by the American Board of Professional Liability as a specialist in Medical Malpractice Law which is recognized by the South Carolina Bar. Randy has also been awarded the distinction of being a “Super Lawyer” 10 times in the last decade. He has over 25 years of experience helping injured people fight back against corporations, hospitals and wrong-doers.
Read more about S. Randall Hood