Power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy).
When used for hysterectomy or mymectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. The FDA is warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. You can read the full text of the November 24, 2014 FDA Safety Communication here.
A Known Danger
The FDA’s Safety Communication on April 17, 2014 states:
Importantly, based upon an FDA analysis of currently available 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 with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
These risks, while finally announced by the FDA in April of 2014, were known by the manufacturers of Power Morcellators for years prior to this disclosure. Unfortunately for women around the country, the manufacturers of these devices chose not to disclose these risks to doctors, who in turn were unable to disclose these risks to patients. Only due to the fight by doctors such as Amy Reed, who was diagnosed with Stage IV uterine cancer shortly after a surgery using power morcellation, have these risks come to light.
Contact A Power Morcellator Attorney at 1-888-426-4156Or Click Here to Email Us
Power Morcellator Manufacturers & Devices
The list of companies selling power morcellation devices includes:
- Gynecare Morcellators, Gynecare Morcellex, Morcellex Sigma (recalled [voluntary market withdrawal] by Ethicon & Johnson&Johnson)
- LiNa Xcise (LiNa Medical)
- Morce Power Plus (NouvagAG)
- PlasmaSORD (Gyrus / Olympus Medical)
- Trokamed Morcellator (Trokamed GmbH)
- Sawahle Morcellator, Rotocut SIII (Karl Storz)
Ethicon Recall & Withdrawal
In April 2014 Ethicon sent this notice to hospital and doctors, warning that their device may be causing or worsening cancer in patients. Following this warning, Ethicon suspended the sales and commercialization of their power morcellation products. They chose at that time to ignore calls for a full recall of their products.
On July 30, 2014, Ethicon sent out an Urgent notice recalling (medical device market withdrawal) all Morcellation devices including generators and disposables. A full copy of the notice can be seen here. This full recall was promoted by a July 10-11 meeting of the U.S. Food and Drug Administration’s (FDA) Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. They noted the “difficulty for medical professionals to preoperatively diagnose some malignancies, such as leiomyosarcoma” and “the risk of disseminating unsuspected malignant tissue with user power morcellation devices”. The July 30, 2014 withdrawal was followed by the July 31, 2014 Voluntary Product Recall Field Safety Notice.
News About the Danger of Power Morcellation
A timeline of power morcellation and ovarian cancer in the news:
December 18, 2013- The Wall Street Journal breaks the story of Dr. Amy Reed, a physician herself, whose uterine cancer was spread by use of a power morcellator in her hysterectomy surgery. Read more at WSJ.com.
February 20, 2014- Temple University Hospital in Philadelphia restricts use of power morcellators in hysterectomies.
April 17, 2014- The FDA issues a warning, advising against the use of power morcellation in hysterectomies and myomectomies. The FDA says power morcellators spread a rare type of cancer that cannot be detected before the procedure. Power morcellation also worsens long-term survival. In 2014, power morcellators were used 50,000 times. The FDA warns that power morcellation spreads and worsens cancer in 1 in 350 women. It advises that doctors should disclose these risks to patients undergoing hysterectomy or myomectomy with a power morcellator.
April 23, 2014- Cleveland Clinic and the University of Pennsylvania Health System suspend use of power morcellation for hysterectomy and myomectomy.
April 29, 2014- One of the largest manufacturers of power morcellators, Johnson & Johnson, suspends sales of its power morcellators until the FDA takes a closer look. Johnson & Johnson accounts for 72% of the morcellator market.
July 14, 2014- The FDA holds a public hearing to discuss whether or not power morcellators should be banned, whether or not warning labels should be required, and whether or not the risk level of morcellators should be changed from moderate to high.
July 23, 2014- Columbia University doctors publish a study confirming that 1 in 368 women undergoing fibroid removal surgery have undetected cancer, which can be spread dangerously if a power morcellator is used in a hysterectomy or myomectomy.
July 30, 2014- Johnson & Johnson makes a full recall of its line of power morcellators.
August 2, 2014- Insurer Highmark Inc. stops covering power morcellation for fibroid removal.
September, 2014- The Wall Street Journal publishes Deadly Medicine, an e-book that tells the story of power morcellation and of Dr. Amy Reed and her husband, Dr. Hooman Noorchashm, who have pioneered the fight to ban power morcellation. Read more and download the e-book at WSJ.com.
November 24, 2014- The FDA requires that manufacturers of power morcellators immediately use a “black box” warning, the strongest warning required by the FDA, to inform doctors and patients of the risks associated with power morcellation in hysterectomy and myomectomy.
Winter, 2014 through Spring, 2015- More hospitals and insurance companies call for a ban on power morcellation, and Health Canada, the FDA’s counterpart in Canada, also calls for stronger warnings.
RECENT UPDATE: The Wall Street Journal Reports The FBI Is Investigating Power Morcellation
On May 27, 2015, The Wall Street Journal reported that the FBI has been investigating power morcellators and the largest manufacturer of the device, Johnson & Johnson. The FBI conducted a series of interviews and discovered J&J knew the hazardous effects of power morcellation, long before the company pulled their power morcellator off the market. Read more at WSJ.com.
Power Morcellator Lawyers & Uterine Cancer Lawyers
If you or a loved one has undergone a hysterectomy, myomectomy, or other procedure and a power morcellator was used, it may have caused your uterine cancer to spread.
Attorneys such as Rachel Abrams are available to speak with you regarding your case, contact us at 1-888-426-4156 or fill out the form on this page, and an experienced power morcellation lawyer will speak with you regarding a Power Morcellator lawsuit. There is a time limit for you to act and file a lawsuit, please contact a uterine cancer power morcellator attorney as soon as possible.