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A fast track to tragedy: the FDA's approval of the morcellator

A power morcellator is a surgical device that allows surgeons to cut up abdominal tissue into small pieces so that it can be removed through a small incision. It was originally designed to be used laparoscopically to minimize incision size and postop pain. Since 1995, it has been used primarily by gynecologists to remove uterine fibroids, or benign growths within the uterus. It is also used to perform hysterectomies or removal of the entire uterus. In fact, 50,000 to 125,000 hysterectomies were performed each year using a power morcellator. While this procedure was convenient and reduced recovery time, the convenience came at a fatal cost to many women.

The power morcellator has a rapidly spinning blade that cuts tissue into tiny pieces spreading throughout the abdomen. While the morcellator removes most tissue from the abdomen, it is not possible to remove all of it. For women who have an undiagnosed uterine cancer (malignant uterine sarcoma), the morcellator will spread cancerous tissue from the uterus to other organs. Consequently, morcellator surgery can turn a Stage 1 cancer into a Stage 4 cancer within a very short time frame.

This Did Not Have To Happen

Like so many medical devices that are later revealed to be defective or dangerous, the Food and Drug Administration (FDA) did not closely scrutinize the morcellator. In fact, every year the FDA approves hundreds of devices on the grounds that they are substantially similar to other medical devices. This is known as the 510k process.

In 1991, the FDA first approved the power morcellator through the 510k process. The applicant, Cook Urological, Inc., did not present any clinical trials to the FDA. In 1995, the FDA approved Karl Storz Endoscopy-America Inc.'s use of morcellators to remove uterine fibroids through the 510k process. The FDA approved similar applications in 1996 and 2000. In each of these cases, the morcellator was approved on the basis that it was substantially similar to other devices.

The problem with this standard is that the medical community and FDA do not always know if a medical device poses risks to the general population. According to a Wall Street Journal article entitled How FDA Approved Hysterectomy Tools It Now Disfavors, the risk of hidden uterine sarcoma was once thought to be as low as one in 10,000. Later studies showed far higher rates, with current estimates to 1 in 352 women believed to have hidden uterine sarcoma. The use of the morcellator causes this once hidden, but treatable cancer, to spread to other organs, making the prognosis far worse. Current studies clearly show that women with undiagnosed uterine sarcoma who undergo morcellation have survival reduced by 50%.

In short, the 510k process allows medical device companies to bring their products to market without fully testing them. With a more stringent application process in place, we could reduce the number of senseless deaths and needless suffering.

Talk To Our Law Firm

If your cancer prognosis has gotten worse due to morcellator surgery, or if you have lost a loved one due to cancer, you may have a claim for damages. It is important to retain lawyers who have a full command of the legal and medical issues involved in these claims. For decades, people across the United States have placed their trust in Fay Law Group, PA. Our attorneys have a legacy of success in a broad range of injury and wrongful death claims.

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