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Morcellation Media Monitoring 01/07/2016
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Congressman seeks criminal investigation of medical device harm
Jan 4, 2016 | Philadelphia Inquirer
By Hooman Noorchashm and Amy J. Reed
Just before Christmas, U.S. Rep. Mike Fitzpatrick wrote a letter to the U.S. Food and Drug Administration that could turn up the heat on investigations into a medical device that has harmed thousands of American women. -
Congressman Requests FDA Inquiry into Morcellation Deaths
Jan 4, 2016 | Injury Lawyer News
By Katarina Siegfeld
A member of congress has sent a letter to the FDA requesting that the organization investigate whether three hospitals violated mandatory reporting policies in connection deaths related to the use of power morcellators during gynecological surgery. -
Two Doctors Call For Power Morcellation Ban
Jan 4, 2016 | Top Class Actions
By Ashley Vanover
Two Harvard doctors are speaking out about the dangerous risks that power morcellation devices pose. Dr. Amy R., a surgical ICU doctor and anesthesiologist, was diagnosed with a rare and aggressive cancer known as leiomyosarcoma shortly after she underwent a laparoscopic hysterectomy to remove uterine fibroids. After discussing her options with her doctor, she opted for this form a surgery, where a power morcellator would be used, instead of an abdominal hysterectomy due to the quicker recovery time.
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Congressman seeks criminal investigation of medical device harm
Jan 4, 2016 | Philadelphia Inquirer
By Hooman Noorchashm and Amy J. Reed
Just before Christmas, U.S. Rep. Mike Fitzpatrick wrote a letter to the U.S. Food and Drug Administration that could turn up the heat on investigations into a medical device that has harmed thousands of American women.
In this letter, the Bucks County Republican asks the head of the Office of Criminal Investigations at the FDA to look into the deaths related to the use of a medical device known as a “power morcellator”.
The request for a criminal investigation is specifically focused on potential wrong doing by prominent hospitals, including Brigham and Women’s in Boston and the University of Rochester Medical Center, as well as the largest manufacturer of the power morcellator, Johnson & Johnson.
Since December 2013, it has become clear that power morcellators can spread and upstage dangerous occult or missed uterine cancers in women. This terrible problem went on for more than 20 years – the epidemiological data suggest that hundreds, if not thousands, of American families have been affected.
But most affected patients did not fully understand what had happened to them - and a majority of gynecologists apparently ignored, failed to recognize or even accepted this collateral damage.
It is astonishing that this deadly, but avoidable, complication in women’s health was not eliminated by gynecological surgeons long ago. Instead, it was the force of public exposure that ultimately brought this practice to light.
Even now, many decorated gynecologists are continuing to endorse this dangerous practice in women.
Though they had known of the problem for years, these women’s health experts did not report it to the FDA.
Now, Congress is getting tuned in, because section 803, Title 21 of the Code of Federal Regulation requires such self-reporting. And it demonstrates that medical device manufacturers and hospitals do not take this law seriously.
The Fitzpatrick letter to the OCI chief is the latest in a series of increasingly visible congressional moves.
Congress has instructed the Government Accountability Office (GAO) to investigate the power morcellator disaster in women’s health. This investigation is ongoing.
The chair of the Energy and Commerce subcommittee on Oversight and Investigations, Rep. Tim Murphy, is also looking at this failure.
The FBI is said to be investigating non-compliance with federal regulation leading to the loss of lives related to the use of power morcellators.
Who knew what, when and why was there such a profound failure to warn the FDA or patients for 20 years? We hope these investigations provide the answers.
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Congressman Requests FDA Inquiry into Morcellation Deaths
Jan 4, 2016 | Injury Lawyer News
By Katarina Siegfeld
A member of congress has sent a letter to the FDA requesting that the organization investigate whether three hospitals violated mandatory reporting policies in connection deaths related to the use of power morcellators during gynecological surgery.
Michael G. Fitzpatrick, representative of the 8th district of Pennsylvania, sent a letter to George Karavetsos, the FDA’s director of the Office of Criminal Investigations, requesting an inquiry into the conduct of officials at three hospitals: Brigham and Women’s Hospital (of Boston); Rochester General Hospital; and the University of Rochester Medical Center.
The letter calls Karavetsos’ attention to three cancer deaths of patients that were likely related to the use of morcellators at the hospital as part of surgical procedures there.
Power morcellators are used to break up tissue for easy removal during minimally invasive surgeries, including hysterectomies and myomectomies (removal of uterine fibroid tumors). The use of the devices has come under fine, however, because it appears that they may spread undetected cancer cells, hastening the death of a number of women who had morcellator-enabled surgeries.
Inquiry related to three hospitals requested
Fitzpatrick notes that under Medical Device Reporting Regulations, hospitals must report to the FDA within 10 days information that “reasonably suggests that a device has or may have caused or contributed to the death of a patient in …[a given] … facility.” (21 CFR 803.30 (a) (1).
The congressman raised questions of three such facilities:
Brigham and Women’s Hospital, where Erica Kaitz had surgery with a power morecellator on June 2012 and subsequently 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 likewise 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.
In the case of all three facilities, Fitzpatrick asked whether the deaths were properly reported to the FDA and, if not, why they weren’t.
Power morcellator lawsuits filed
Fitzpatrick was one of 12 legislators who sent another letter in August to the Government Accountability Office requesting an investigation into the FDA’s approval process for power morcellators. Their inquiry was prompted by the growing number of lawsuits filed against medical device manufacturers over the deaths allegedly related to the devices’ use. All morcellator lawsuits related to the spread of cancer in connection to the use of morcellators have been centralized in the District of Kansas under U.S. District Judge Kathryn H. Vratil as part of a multidistrict litigation (MDL).
The devices have become so controversial that the chief morcellator manufacturer Ethicon (a subsidiary of Johnson & Johnson) announced that they were no longer producing them. Representatives of the company were quick to point out that this move stopped short of a “recall” of the product, arguing that the products themselves were not defective in and of themselves. While some hospitals no longer use the devices at all, others have retained limited use of morcellators, arguing that in certain circumstances the devices do more good than harm.
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Two Doctors Call For Power Morcellation Ban
Jan 4, 2016 | Top Class Actions
By Ashley Vanover
Two Harvard doctors are speaking out about the dangerous risks that power morcellation devices pose.
Dr. Amy R., a surgical ICU doctor and anesthesiologist, was diagnosed with a rare and aggressive cancer known as leiomyosarcoma shortly after she underwent a laparoscopic hysterectomy to remove uterine fibroids. After discussing her options with her doctor, she opted for this form a surgery, where a power morcellator would be used, instead of an abdominal hysterectomy due to the quicker recovery time.
However, it was during this surgery that the power morcellator disseminated undetected uterine sarcoma throughout her abdominal cavity, leaving her with a virtual death sentence.
In October 2013, Dr. Amy underwent several aggressive and expensive procedures to stop the spread of the leiomyosarcoma including having her insides soaked with chemo, removal of her gallbladder, appendix, ovaries and various membranes that held her organs in place. After the procedure, she suffered a blood clot in her lungs and was hospitalized for eight days.
Doctor Calls for Morcellation Ban
Dr. Amy’s husband, a Harvard cardiac surgeon, began to research medical databases and got a sense that the risk of power morcellation cancer was high. In his attempt to bring attention to these risks, however, he was met with red tape and little support from hospital administrators. Still, despite this red tape and being ostracized from the hospital community, he pursued his campaign against the use of power morcellators. He even took his plight to the FDA and a Change.org petition.
It was here that he learned that his wife was not the only victim of morcellation cancer. As his own wife was undergoing surgery, another patient, Erica K. was nearing death as an alleged result of morcellation surgery. In fact, just four days before Dr. Amy’s husband met with hospital administrators, Erica died.
Still, Dr. Amy’s husband continued his crusade and small changes began to happen – a handful of area hospitals began placing mandates on morcellation surgery and Senator Elizabeth Warren began taking an interest in his cause. In 2014, the FDA issued a safety communication “discouraging” the use of power morcellators for gynecological surgeries.
Yet, Dr. Amy’s husband feels, that while a small victory, it is not enough. He is adamant that the devices be banned due to their inherent risk of spreading cancer. And finally he was listened to.
FDA Addresses Morcellation Cancer Concerns
After the FDA announcement, the American College of Obstetricians and Gynecologists announced they would be thoroughly investigating use of the devices and many hospitals opted to ban the use of the devices. Then, Johnson & Johnson, a leading manufacturer of power morcellators, announced it would be suspending worldwide sales and distribution and marketing of the surgical tools.
However, this response came too late for many women who underwent a laparoscopic surgery and were diagnosed with cancer. In Spring 2015, Dr. Amy was told her leiomyosarcoma had returned an underwent additional surgery and started radiation treatment.
What is Power Morcellation?
Laparoscopic power morcellation is a procedure that uses a device called a morcellator to slice the affected tissue into small pieces and remove it through small incisions in the abdomen. This type of surgical treatment was found to decrease the recovery time, pain, blood loss, and scarring.
But, since doctors are unable to tell whether or not a fibroid contains cancerous tissue before removal, this procedure carries the risk of spreading any cancerous tissue into other parts of the body.
Several studies have found an increased risk in the spread of cancerous tissue after a woman undergoes a power morcellation procedure.
The Journal of the American Medical Association, JAMA, published a study in March 2014 that found 13 women between 1983 and 2010 unexpectedly developed uterine cancer after undergoing power morcellation.
An additional study published in March 2014 in PLOS One showed that women were nine times more likely to develop cancer after undergoing power morcellation to remove their uterus or uterine fibroids.
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