Lawsuits have been filed. Equipment has been withdrawn from the market. The U.S. Food and Drug Administration put out safety alerts. And, now, U.S. senators have called for a swift and stern regulatory response. All of these developments pertain to the use of the laparoscopic power morcellator.
Laparoscopic power morcellators are medical devices used during different types of surgeries, including hysterectomy and the removal of uterine fibroids. The device divides the tissue into fragments to make it easier to remove them through small incisions.
The U.S. Food and Drug Administration in April issued a safety communication discouraging the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
“It is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma,” according to the FDA. “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.
“For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
U.S. Sen. Charles Schumer and U.S. Sen. Kirsten Gillibrand sent a letter to the FDA on Aug. 19 urging the FDA to do more. The senators noted one manufacturer’s unilateral action.
“Johnson & Johnson’s Ethicon division, the leading manufacturer of morcellation equipment, promptly withdrew their products from the market. … [W]e urge the FDA to request that other manufacturers of laparoscopic morcellation devices withdraw their equipment from the market until additional risk assessments and patient and clinician education can be performed.”
Power morcellator lawsuits have been filed. The product liability attorneys at Reich & Binstock take these injury claims seriously and urge women to come forward if they have experienced the spread of uterine cancer that may be linked to the use of a laparoscopic morcellation device. Any such patient is entitled to a free consultation from one of Reich & Binstock’s experienced attorneys. All one must do is either call the toll-free number below or send a request through the law firm’s website.
Reich & Binstock operates in all 50 states, so residency has no bearing on representation.