Michael G. Fitzpatrick, representative of the 8th district of Pennsylvania, has asked the FDA’s Office of Criminal Investigations, to investigate whether three hospitals violated mandatory reporting policies in wrongful deaths related to the use of power morcellators during gynecological surgery.
Brigham and Women’s Hospital (of Boston); Rochester General Hospital; and the University of Rochester Medical Center are implicated in failing to report these surgical deaths, that were likely related to the use of morcellators at the hospital as part of surgical procedures there.
What are Power Morcellators?
Power morcellators are surgical medical devices that are used to grind up uterine tissue for easy removal during minimally invasive laparoscopic surgeries, during hysterectomies and myomectomies (removal of uterine fibroid tumors).
The use of these grinder devices has come under close scrutiny and warnings, because they may spread undetected uterine cancer cells, accelerating the death of a number of women who had morcellator-enabled surgeries.
Unreported Uterine Cancer Wrongful Death
Brigham and Women’s Hospital, where Erica Kaitz had surgery with a power morcellator on June 2012 and died of a leiomyosarcoma that was undetected and likely spread by morcellation.
Rochester General Hospital, where Barb Leary also had surgery with morcellation in 2009 and died of leiomyosarcoma that was undetected and spread by the surgery. Linda Interlichia, who was operated on in 2013 died the following year of the same cause.
University of Rochester Medical Center, where Brenda Leuzzi had surgery in 2012 that led to a similar outcome two years later.
Latest Power Morcellator Lawsuit
Audrey and Darryl Rayford from Louisiana, filed their complaint in U.S. District Court for the Western District of Louisiana on December 15, alleging that Audrey Rayford underwent a laparoscopic supracervical hysterectomy using power morcellation in December 2014.
According to the Rayfords, the power morcellator device manufactured by Storz Americaa, led to the spread of a potentially deadly uterine cancer in the wife. The Rayfords said the company failed to alert doctors and the general public to the risk that the device could spread undetected cancer cells, making the cancer much more difficult to treat.
Risk of Uterine Cancer Spread With Power Morcellation
Women with undetected uterine cancer that undergo power morcellation procedures may find the cancer spreads during the surgery, making it much more difficult to treat.
According to Rayford, prior to her surgery she had no evidence of metastasized uterine cancer but after her procedure, Rayford was told she had cancer of the uterus. She later discovered that the use of morcellation during her surgery cause the spread or upstaging of her cancer.
Deadly Uterine Sarcoma Spread Linked to Morcellators
Undiagnosed uterine sarcoma is a type of cancer that can be be spread by morcellation procedures. Uterine sarcoma is a rare form of uterine cancer that typically has a good prognosis if the cancer is detected before it spreads to the abdomen and pelvis. Once the uterine cancer has metastasized, cancer treatment becomes less successful and leads to early death usually within 2 years of diagnosis.
FDA 2014 Warning
In April 2014, the FDA issued a warning notifying doctors and patients that power morcellators could spread undetected uterine cancer cells. There is no reliable method to diagnose if cancer cells are present prior to a hysterectomy procedure, and so the FDA recommended at the time that patients be counseled on the risks associated with power morcellators.
The FDA also advised that morcellators should not be used in the majority of hysterectomies and myomectomies, since open or vaginal procedures are associated with better results and fewer complications.
FDA Morcellator Black Box Warning
On July 30, 2014, Johnson & Johnson subsidiary, Ethicon, announced a voluntary power morcellator recall. The Johnson & Johnson company, controlled more than 70% of the market, notified doctors to return all of its power morcellator products, stop using them and said it was withdrawing from the power morcellator market.
The FDA announced November 24, 2014 that it is adding a black box warning to uterine morcellator devices that remain on the market. A BLACK BOX WARNING, is the strongest warning that can be placed on any medical device.
Patients, doctors and hospitals are now on notice of the potential danger of increased uterine cancer spread risk associated with the use of these devices. Furthermore, the FDA announced that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision.
This contraindication prohibits the use of the devices in the vast majority of women who undergo laparoscopic or vaginal uterine morcellation procedures.
Federal Multidistrict Litigation
In October 2015, all federal lawsuits involving Johnson and Johnson Ethicon only power morcellators were coordinated into multidistrict litigation in Kansas, for pre-trial discovery and consolidation.