Two Pennsylvanian lawmakers are urging the FDA to reexamine its 510(k) program, which allows medical devices like the controversial power morcellators to have a fast-track approval process.

Senator Robert Casey and Representative Michael Fitzpatrick have addressed the FDA with concerns that the program allows manufacturers to get approval on medical devices without pre-market testing as long as they can prove the product is “substantially equivalent” to other devices already on the market. This medical device approval policy is concerning to lawmakers, as recent studies have linked the use of a power morcellator in hysterectomy procedures to an increased risk of developing uterine fibroid cancer.

Power Morcellator Cancer Risks

Power morcellator are used in hysterectomies in order to provide patients with a shorter post-operative recovery time when compared to traditional abdominal hysterectomies. While the medical tool provides a less invasive procedure for patients, researchers have found that using the power morcellator on unsuspected cancer tissues may cause the cancer to spread throughout the abdomen. Since there is no real way to detect if uterine sarcoma exists prior to having surgery, this uterine cancer danger has made power morcellator use in laparoscopic hysterectomy procedures a serious health risk for women. 

Studies show that 1 in 350 women who undergo a morcellation hysterectomy or myomectomy procedure are eventually diagnosed with uterine sarcoma. Due to these recent findings, some of the largest health insurance companies in the United States, including Cigna, Aetna and UnitedHealth Group Inc., are choosing not to cover the use of a power morcellator because of the high uterine cancer risk.

The FDA has issued power morcellator warnings in a recent report that encourage physicians, patients, and manufacturers to take the following actions:

• Doctors have been asked to “carefully consider alternative treatment options for the removal of symptomatic uterine fibroid” and to limit the number of laparoscopic incisions that use a power morcellator.
• Patients are urged to find out if a doctor plans to use a power morcellator if they recommend a laparoscopic hysterectomy or myomectomy procedure.
• Manufacturers are strongly urged to include the strongest caution issued by the FDA called a “black box” warning on all new and existing power morcellators. The black box warning is the final step before the FDA will take a product off the market. 

Lawmakers think the FDA could be doing more. Congressman Fitzpatrick states that the agency needs to not let medical tools like the power morcellator slip through the approval process so easily. Likewise, Senator Casey would like to know how the FDA decides if it needs to force a power morcellator recall or encourage the makers to do so on their own.

Power Morcellator Lawsuits

Johnson & Johnson, one of the leading power morcellator manufacturers, has already decided to stop selling the medical tool until its connection to spreading cancer is better understood. Johnson & Johnson is not the only maker of the medical tool, and since a full recall has not been ordered, other companies will continue to produce the potentially cancer-causing product.

Power morcellator lawsuits have been filed against manufacturers by patients who claim the company was aware of the serious cancer risks involved with using the product, but chose to downplay any concerns to physicians and patients. If you have suffered injuries after a hysterectomy procedure, you may be eligible to join a power morcellation cancer class action lawsuit.