Senators Call for Recall of Power Morcellators

 Posted on September 15,2014 in Defective Medical Devices

In August, two U.S. senators began pressing the Food and Drug Administration (FDA) to take power morcellators off the American medical device market. According to the FDA, laparoscopic power morcellators are used to help remove tissue through small incision sites, and are most commonly used in hysterectomies or during the surgical removal of uterine fibroids (myomectomy).

The FDA clearly states that when used for either purpose, the morcellators “poses a risk of spreading unsuspected cancerous tissue” beyond the uterus and into the bloodstream. As such, the agency discourages the use of morcellators but does not outright forbid their implementation. This is what New York Senators Chuck Schumer and Kirsten Gillibrand are attempting to quell.

According to an article in Modern Heathcare, in August Senators Schumer and Gillibrand wrote a letter to the FDA requesting that the agency to remove the morcellator devices from the market. The letter, reports Modern Healthcare, cites a recent survey done at Boston's Brigham and Women's Hospital which found that women who had morcellators implemented were at a nine times higher risk of having the cancer spread than what was communicated to them at the time of surgery.

The medical device manufacturing giant Johnson & Johnson “suspended sales of its morcellators in the U.S. in April after the FDA discouraged doctors from using the tool given the risk that it could spread undetected uterine sarcomas.” In July, however, a worldwide morcellator device market withdrawl was issued.

In the wake of the first wave of consumer complaints and lawsuits filed against the medical community for the use of morcellators, the FDA advised that all women who may undergo these procedures should first insist on a test to determine the possible presence of cancer. The FDA committed that it would convene a public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee in an effort to determine in which circumstances the implementation of a morcellator may be worthwhile. In the meantime, it may be wise to avoid having such surgery.

If you or someone you know has been negatively affected by a power morcellator or any other defective medical device, you may be eligible for compensation. Do not go through it alone. Contact an experienced Arlington Heights defective medical device attorney today.