- J&J Withdraws Morcellators From Market Due to Cancer Risk
- August 11, 2014 | Author: Annika K. Martin
- Law Firm: Lieff, Cabraser, Heimann & Bernstein, LLP - New York Office
Johnson & Johnson ("J&J") is asking doctors to return its laparoscopic power morcellators, controversial surgical devices that may inadvertently spread cancer in women being treated for uterine growths called fibroids. The company's Ethicon unit in April suspended sales and distribution of the devices while their role in treating symptomatic fibroid disease is reviewed by the Food and Drug Administration and the medical community. In April 2014, the FDA advised doctors not to use the devices, pending further review. J&J is now taking the further step of reaching out to customers to ask them to return the devices they have already bought in what it is calling "a worldwide market withdrawal" of all Ethicon morcellation devices that remain on the market.
The morcellators are used to cut up uterine growths so they can be more easily removed using noninvasive procedures. They are also used in hysterectomies. But the masses may sometimes be malignant, and the FDA has warned patients and doctors that the spinning blade of the morcellators could spread deadly cancer and worsen patient outcomes.
Johnson & Johnson has not accepted legal liability for the alleged injuries from cancer caused by its power morcellators. Lieff Cabraser represents victims of defective medical devices across America in lawsuits against manufacturers to obtain just compensation for their pain, suffering, lost wages, and other losses and injuries.
The Alleged Problem with Power Morcellators in Women Developing Uterine Fibroids
Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus. Most women will develop uterine fibroids (also called leiomyomas) at some point in their lives, although most cause no symptoms. In some cases, however, fibroids can cause symptoms, including heavy or prolonged menstrual bleeding, pelvic pressure or pain, and/or frequent urination, requiring medical or surgical therapy.
Many women choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection compared to abdominal hysterectomy and myomectomy. Many of these laparoscopic procedures are performed using a power morcellator. Today, 55,000 to 75,000 U.S. hysterectomies a year involve morcellators, estimate gynecological groups and research hospitals. Doctors also use them in myomectomies, the removal of fibroids alone.
A number of additional treatment options are available for women with symptomatic uterine fibroids including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy. Evidence demonstrates that, when feasible, vaginal hysterectomy is associated with comparable or better results and fewer complications than laparoscopic or abdominal hysterectomy.
Based on an FDA analysis of current data, 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. 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 wth fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.