There are multiple companies who have manufactured power morcellators used for gynecological surgeries such as laparoscopic hysterectomy or fibroid removal, all of which may pose significant risk. As the FDA has not issued a wholesale recall and the Ethicon recall was “voluntary”, many devices, including those manufactured by Johnson & Johnson may actually still be in use. These companies and their devices include:
- Ethicon / Johnson& Johnson
- Gynecare Morcellex
- Gynecare X Tract
- Morcellex Sigma
- Diva by FemRx
- Lumenis Ltd.
- VersaCut+Tissue Morcellator
- PKS PlasmaSORD
- VarioCarve Morcellator
- Karl Storz GmbH
- KSE Steiner Electromechanic Morcellator
- Richard Wolf GmbH
- Morce Power Plus
- Cook Urological Inc.
- Cook Tissue Morcellator
- Smith & Nephew
- TRUCLEAR Morcellation System
- LiNA Medical
- Blue Endo
Three of the companies, Ethicon, LiNA, and Blue Endo have been named in lawsuits regarding injuries or deaths caused by the development of cancer after power morcellator devices were used in hysterectomy procedures. Cancers caused or spread by power morcellators may include leiomyosarcoma, endometrial stromal sarcoma, endometrial adenocarcinoma, and carcinoma.
Manufacturers including Johnson & Johnson through their subsidiary, Ethicon, face multiple lawsuits regarding cancer development and death after power morcellator use including:
- A March 2014 lawsuit filed in the U.S. District Court, Eastern District of Pennsylvania. The suit was filed by the husband of a 53 year old woman who died from uterine cancer less than a year after having a power morcellator assisted hysterectomy to treat uterine bleeding.
- A lawsuit filed in the U.S. District Court for the District of New York. The suit was filed by a woman diagnosed with occult uterine leiomyosarcoma after having a hysterectomy using a power morcellator. Her life expectancy and quality of life has been dramatically reduced.
- A lawsuit filed in Florida by a female patient with no prior signs or symptoms of cancer who underwent hysterectomy to remove fibroids. The procedure reportedly spread a previously undetected endometrial stromal sarcoma cancer throughout her abdominal cavity. Her life expectance and quality of life has also been dramatically reduced.
The plaintiffs and representing lawyers claim that the company knew of and failed to warn patients and the medical community of the increased risk of cancer development following power morcellator use. Plaintiffs also claim that the companies failed to make the devices safe for their intended use.
Many more lawsuits are expected.
About Power Morcellators
Power morcellator is a medical instrument designed to be used in laparoscopic surgeries. It is inserted through the small incision made for the surgery to remove large tissue sections by “morcellating” or mincing the tissue into smaller pieces that are more easily extracted.
Power morcellators are used for minimally invasive hysterectomies and fibroid tissue removal. They have been used in thousands of laparoscopic hysterectomies and have been shown to increase the risk of developing a severe form of a rare type of uterine cancer.
Several manufacturers including Ethicon, a subsidiary of Johnson & Johnson, the largest global manufacturer of medical products are facing lawsuits regarding cancer development after power morcellator hysterectomy.
Ethicon has suspended sales and issued a voluntary recall affecting all three of the power morcellators produced by the company. Johnson & Johnson, the parent company of Ethicon had worldwide sales of over $71 billion in 2013.
Risks of Power Morcellator Hysterectomy
The FDA has estimated that 1 in 350 women who have a power morcellator laparoscopic hysterectomy or fibroid removal procedure may be at risk for the widespread development of the fatal type of uterine cancer known as leiomyosarcoma.
In addition to cases of leiomyosarcoma, power morcellators may also spread the development of a benign type of tumor known as leiomyoma. Even though the tumor is not cancerous, when cells are spread through morcellation, they may begin growing fibroid tissue throughout the abdomen causing extensive pain as they are inoperable.
Power morcellators may also cause a number of adverse events that are not dangerous but can significantly impair quality of life such as:
Despite the lack of severe risks – power morcellation procedures do have some side effects such as:
- Bleeding, oozing and pain at incision site
- Soreness and bruising
- Infection and abscess
- Damage to surrounding organs
- Pelvic and abdominal pain
- Fibroid reoccurrence
Any changes after a surgical procedure should be reported to a physician.
Power Morcellator Warnings and Recalls
The first power morcellators were approved in 1993 by the Food and Drug Administration. They have been used in hundreds of thousands of laparoscopic surgeries including splenectomy, gall bladder removal, and hysterectomies.
In 2006, Dr. Robert Lampartar, a pathologist at Evangelical Community Hospital in Lewisburg PA sent a letter to Johnson & Johnson warning the company that the devices “may lead to dissemination of malignant tissue” and asking that the company carefully consider the risk of continued use. Johnson & Johnson subsequently added a labeling precaution in the use instructions but did not issue any widespread warnings and subsequently ignored additional letters from Dr. Lampartar.
On April 17, 2014, a warning letter was issued by the FDA stating that the use of power morcellators may spread cancers when used to remove fibroid tumors. After the warning letter was issued, Johnson & Johnson suspended additional sales of the three Ethicon power morcellator models.
An FDA Advisory Committee meeting, conducted in July of 2014, concluded that surgeons who used power morcellators should make additional efforts to inform patients about the risks of the use of the machines. The committee also suggested the addition of serious warning statements to product packaging and recommended increasing the device classification to the higher Class III category which would require new manufactures to present proof of safety and efficacy through extensive clinical studies.
In July of 2014, a study published in the Journal of the American Medical Association (JAMA) showing increased uterine pathology following morcellator use. Following the publication, Ethicon issued a voluntary recall of their devices.
As the recall was not mandatory, some hospitals and medical centers have discontinued the use of power morcellators as institutional policy. Banning hospitals includes notables such as Boston Medical Center, Brigham & Young Women’s Hospital, Tufts Medical Center, and Massachusetts General Hospital.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.