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Morcellation Media Monitoring 09/14/2015
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Viviana Ruscitto (1971-2015): Mother, Wife, Daughter, Guardian of Women's Health
Sep 10, 2015 | The Philadelphia Inquirer
By Hooman Noorchasm
On September 10, 2015 I drove to a small town tucked away in the Hudson Valley - a few miles north of New York City. I went to Nyack, NY to pay my respects to Viviana Ruscitto and her family at her funeral mass. I felt compelled to go, even though I did not know her or her family personally. -
Slaughter tells widowers GAO will study morcellation
Sep 11, 2015 | Rochester Democrat and Chronicle
By Patti Singer
An investigation into what the Food and Drug Administration knew about devices that can spread undetected cancer cells during minimally invasive hysterectomies is expected to start in about five months. Too late for three Rochester-area families, but the widowers marking sad anniversaries this month and next hope the findings will spare other families from similar grief. -
Woman suing The Valley Hospital dies
Sep 12, 2015 | NorthJersey.com
By Lindy Washburn
A woman who sued The Valley Hospital, her doctors and the maker of a medical device that she claimed caused the spread of her cancer has died, just days after providing videotaped testimony to be used when her lawsuit comes to trial. Viviana Ruscitto, a radiology administrator and the mother of a 2-year-old boy, was 43. -
WSJ: Feds to launch power morcellator probe aimed at FDA
Sep 11, 2015 | Fierce Medical Devices
By Emily Wasserman
The FDA has been getting it from all sides lately for its oversight of power morcellator devices, with lawmakers last month urging the U.S. Government Accountability Office (GAO) to probe the agency's regulation of the products. Now, the GAO is planning to take on the charge and launch an investigation into the devices. -
Medical landscape ‘continuing to evolve’ after FDA guidance about power morcellation
Sep 10, 2015 | Healio
By Jennifer Southall
The FDA issued guidance last fall about the use of laparoscopic power morcellation for treatment of uterine fibroids. The agency warned against use of the technique during most myomectomies and hysterectomies due to the potential that it could spread undetected uterine sarcomas. -
Report: Feds to investigate power morcellators
Sep 11, 2015 | Mass Device
By Fink Densford
The Government Accountability Office said last week it will investigate potential safety and regulatory issues with laproscopic power morcellators, according to The Wall Street Journal. The devices use small, rotating blades to break up large tissue masses into fragments, and are commonly used to remove uterine fibroids in women. However, if the device is used on a patient with an undetected cancerous growth, it can enable the cancer to spread, according to the FDA. -
MIS Procedures Decrease After FDA Guidelines
Sep 11, 2015 | Michigan Health System
Since the Food and Drug Administration (FDA) cautioned against using a minimally invasive method to treat fibroid tumors called power morcellation, there was a nearly quarter increase in hospital readmissions and 27 percent increase in major postoperative complications after hysterectomies in Michigan, a new University of Michigan study says. -
Treatment For Fibroid Tumors Raises Risk Of Spreading Cancer
Sep 14, 2015 | Vocativ
By Tracy Clark-Flory
A new study adds fuel to an ongoing debate over women’s healthcare: if a surgical procedure associated with dramatically fewer post-operative complications puts some patients at risk for life-threatening cancer, is it worthwhile? -
GAO to Investigate Power Morcellation Harms
Sep 11, 2015 | The Cancer Letter
By Matthew Bin Han Ong
The U.S. Government Accountability Office said it would investigate the controversy stemming from wide use of power morcellators, gynecological devices now known to spread undetected cancers during hysterectomies and myomectomies. The GAO’s Sept. 4 move comes after 12 members of Congress wrote a letter requesting an investigation. -
Michigan Woman Files Power Morcellator Lawsuit
Sep 11, 2015 | The Legal Herald
By Laurence Banville
Karl Storz Endovision Inc. find themselves named as the defendants in a power woman recovering from power morcellator lawsuit filed on January 26th, 2015 in the U.S. District Court for the Eastern Division of Michigan under case number 2:15-cv-10352-TGB-APP. This is just one of many lawsuits which have been filed against companies who manufacture power morcellators. A Michigan woman, who underwent surgical procedures known as a laparoscopic supracervical hysterectomy and bilateral salpingectomy to treat her uterine fibroids on June 14th, 2011, alleges that she is now battling stage-4 cancer due to the use of a power morcellator. -
Power Morcellator Lawsuit – A Look Back At The First Five Plaintiffs
Sep 10, 2015 | The Legal Herald
By Laurence Banville
The power morcellator: initially this surgical tool was thought to be a wondrous invention that would bring about a new era of non-invasive laparoscopic surgery. Approval was granted by the U.S. Food and Drug Administration under a 501(k).
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Morcellation
Full Text of Stories Below
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Viviana Ruscitto (1971-2015): Mother, Wife, Daughter, Guardian of Women's Health
Sep 10, 2015 | The Philadelphia Inquirer
By Hooman Noorchasm
On September 10, 2015 I drove to a small town tucked away in the Hudson Valley - a few miles north of New York City. I went to Nyack, NY to pay my respects to Viviana Ruscitto and her family at her funeral mass.
I felt compelled to go, even though I did not know her or her family personally.
What I saw was a beautiful family, full of grace, and a small Catholic church brimming with love and sorrow. You can read Viviana’s obituary here.
My wife and I have been working daily for almost two years to put a stop to morcellation, a deadly gynecological practice that harmed my wife, and many other women.
Morcellation took the life of Viviana Ruscitto by spreading an aggressive cancer throughout her body. Where a cure would have been possible using proper surgical technique, Viviana was robbed of the chance.
The heart-wrenching coincidence for me was that Viviana’s operation was performed exactly a year after my wife’s – on October 17, 2014.
There are some unforgivable facts about Viviana’s case that must be documented for the sake of patient safety in the United States.
Viviana was fatally harmed six months after the April 2014 FDA advisory about the dangers of power morcellation, and three months after a well-publicized FDA hearing on the procedure.
Her hidden cancer was morcellated three months after the largest manufacturer of the device, J&J, withdrew its device from the market. Her surgeon reportedly used a morcellator manufactured by Karl Storz Co., which was the same the one used in my wife’s operation. But the company refused to withdraw it from market – instead their executives threatened to take legal action against my wife and I, if we did not cease “defaming” their product and good name. You can read the about this corporate threat against us here.
Viviana’s life could have been saved if the manufacturer, her doctor and hospital taken the warnings seriously.
And, very certainly, both Viviana and my wife would have been protected, had the U.S Senate taken seriously the warnings issued by the Institute of Medicine in 2011 regarding safety standards governing medical devices in the United States. You can read more here.
As I left the church after Viviana’s mass, I told her sister, “You don’t know me. I am sorry we weren’t able to stop this in time to protect your sister. But I promise you that her fight will not be forgotten.”
Viviana’s death will not be in vain – because her tragedy has demonstrated a very severe and costly lapse in FDA regulation of medical devices - to our congress, and to the American public. Her struggle will serve to protect future patients.
Members of Congress, including Pennsylvania’s Mike Fitzpatrick and Tim Murphy, as well as, Colorado’s Diane DeGette know the name Viviana Ruscitto – and they have more than outrage to bring to the fight against corporate carelessness and FDA laxity.
Rest in peace, Viviana.
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Slaughter tells widowers GAO will study morcellation
Sep 11, 2015 | Rochester Democrat and Chronicle
By Patti Singer
An investigation into what the Food and Drug Administration knew about devices that can spread undetected cancer cells during minimally invasive hysterectomies is expected to start in about five months.
Too late for three Rochester-area families, but the widowers marking sad anniversaries this month and next hope the findings will spare other families from similar grief.
Frank Interlichia, Jim Leary and George Leuzzi recently met with Rep. Louise Slaughter, D-Fairport, to learn that the Government Accountability Office will review the FDA action – or inaction, depending on your point of view – on power morcellators.
“I believe that this whole situation is long overdue to be investigated,” Leuzzi responded in an email to a request for his reaction to the recent meeting. “It should be in the hands of our elected officials for the proper action to take place. My hope is their investigation leads to the elimination of this product permanently.”
Leuzzi’s wife, Brenda, died last October from complications after a power morcellator was used during surgery for what was thought to be benign tissue called fibroids. However, pathology reports later showed the tissue harbored cancer.
Power morcellators are devices with high-speed blades that cut tissue into tiny pieces so they can be removed through the small incisions of minimally invasive surgery. However, the centrifugal force of the blades can spread the tissue. With no way to know for certain before surgery whether the tissue truly is benign, the use of power morcellators can allow tumor cells to “seed” in other areas of the abdomen.
Interlichia’s wife, Linda, also died in October 2014. Leary’s wife, Barbara, had died in September 2013. The circumstances of all three were the same. The men did not know each other, and they weren’t aware of the implications of the procedure until a Boston doctor raised the alarm and the Wall Street Journal began investigating.
Rochester Regional Health and UR Medicine were among the first systems in the country to stop using power morcellators.
Over the next few months, the FDA issued advisories and held hearings, but stopped short of outright banning the use of power morcellators. The agency recommended manufacturers put a warning on the devices and that doctors counsel patients about risk.
In August, Slaughter was among 12 Congressional members to ask the GAO to investigate what led to approval of the device in the first place.
On Sept. 1, Slaughter received a letter from the GAO, stating an investigation would be scheduled as soon as staffers with the required skills were available.
“I appreciate all she’s done,” Leary said. “I appreciate the GAO. I’m a little skeptical on how they’re going to do this and will they be able to come up with true and accurate information.”
There has been debate over just how many women are affected, with some who support morcellation calling the problem rare and considering the procedure of using a morcellator routine while families of women affected say the types of cancers that are spread are far too common.
The GAO has broad powers, including the ability to issue subpoenas.
Interlichia said patient safety has to be paramount. “ ‘First, do no harm, right,?’” he wrote.
Asked what he hoped the meeting with Slaughter and the GAO investigation would accomplish, he also wrote,
“We also wanted to raise a question: if this "rare" cancer and "routine" procedure claimed the lives of three women in 13 months in a mid-sized city in Upstate New York, how often was it happening--is it still happening--in major metropolitan areas around the country (and the world)? There are still physicians and leaders of professional associations in gynecological surgery that defend the practice; who have been quoted in the national media as saying they tell patients the risks, but also tell them that they don't believe the data. There has been a positive and appropriately humane response from many physicians, hospitals and insurers. But given the eerily similar experience that our wives had Jim, George and I don't believe that the "informed consent" process sufficiently protects or informs patients. It is too subjective, too variable, too reliant on the assumption that all physicians are sufficiently knowledgeable and unbiased.
“I can only speak for myself, but I suspect Jim and George feel the same way: my fear is that if this issue is not kept in the public eye that morcellation will continue and perhaps begin to increase again. Corporate profits and professional arrogance are strong and persistent forces. …. "
The GAO did not say how long its investigation would take. Some might argue it's already been too long.
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Woman suing The Valley Hospital dies
Sep 12, 2015 | NorthJersey.com
By Lindy Washburn
A woman who sued The Valley Hospital, her doctors and the maker of a medical device that she claimed caused the spread of her cancer has died, just days after providing videotaped testimony to be used when her lawsuit comes to trial.
Viviana Ruscitto, a radiology administrator and the mother of a 2-year-old boy, was 43.
Ruscitto was diagnosed with metastatic leiomyosarcoma, a rare and aggressive cancer, a few weeks after undergoing surgery for uterine fibroids at the Ridgewood hospital last October.
During the minimally invasive procedure, a device known as a laparoscopic power morcellator was used to shred and grind the tissue to be removed so that the fragments could be sucked out through a small incision.
The morcellator’s spinning blade disperses particles from the shredded tissue throughout the abdomen and enables some cells to be absorbed and transported by the lymph system.
The federal Food and Drug Administration recently said that 1 in every 350 women who undergoes a hysterectomy for fibroids has a cancer that may not have been detected but would be spread through morcellation.
At Ruscitto’s funeral Thursday in Nyack, N.Y., the lawsuit was not mentioned. Instead, a standing-room-only congregation at St. Ann R.C. Church heard of her love for her son Maximo, her devotion to Padre Pio, an Italian monk who was canonized in 2002, and the goals she had set and attained as she progressed from Nyack High School through bachelor’s and master’s degrees and additional certifications to become the director of diagnostic imaging at a Westchester medical practice.
Her brother and sister read from the Old and New Testaments, their voices cracking.
"Viviana’s case is very, very tragic," said Hooman Noorchashm, a Philadelphia cardiac surgeon who has spearheaded a national effort to make physicians and patients aware of the dangers that morcellators pose, get them removed from the market, and change the FDA’s approval process.
Noorchashm’s wife, Amy Reed, also a doctor, is fighting the same metastatic cancer after a similar operation with a power morcellator a year before Ruscitto’s surgery.
In an interview, he said that "Viviana’s death was unnecessary and completely avoidable and the result of the FDA not taking action in face of clear public health hazard." Noorchashm, who attended the funeral, has called for a congressional review of the FDA’s approval process for medical devices.
Last week, the federal Government Accounting Office said it would investigate the device and the approval process that led to its use for more than two decades. The probe is in response to a letter from 12 members of Congress, including U.S. Rep. Bill Pascrell Jr., the Paterson Democrat.
The Newark office of the FBI is also reported to be investigating whether the device manufacturers, hospitals or doctors illegally failed to report adverse events caused by the device.
Months before Ruscitto’s surgery, the federal Food and Drug Administration issued a safety communication discouraging the use of power morcellators for surgery to remove fibroids or the uterus and held two days of hearings on the issue.
Just a month after her operation, the FDA upgraded its advisory to a black-box warning against the use of power morcellators "in the majority of women." Johnson & Johnson, the largest manufacturer of power morcellators, suspended its sales of the device and then withdrew from the market in July 2014.
Ruscitto’s lawsuit, filed in U.S. District Court in Newark in August, is the third in New Jersey and one of nearly two dozen around the country about the use of power morcellators.
As her health worsened last month, Ruscitto’s attorneys, Demetrios Stratos of Fair Lawn and Michael Gunzburg of New York, asked the judge to allow them to take her testimony as soon as possible. Federal Magistrate Joseph A. Dickson agreed, and the deposition was recorded during the last week of August.
Besides the device manufacturer, Karl Storz Endovision, a German company, the lawsuit names three doctors: Howard H. Jones, a gynecologic surgeon; Eugenia C. Kuo, a gynecologist; and Celeste A. Telfeyan, an anesthesiologist, all at The Valley Hospital.
The case includes malpractice claims against the doctors because, it argues, there was so much publicity surrounding the danger of power morcellators that they should have known not to use the device.
The case is pending in federal court. Attorneys for the manufacturer have asked for a hearing on Oct. 5 on their motion for dismissal.
Ruscitto told her priest two days before she died that she wished she had more time with her son, he said, and she questioned why her life was ending so soon.
"Viviana encompassed an amazing mix of grace and grit," her obituary said, noting her infectious smile and quick wit. "She was an example of the value of building one another up and always moving forward. Viviana lived in such a way that if someone gave her the shirt off their back – she would give it back but add a shirt and a free gift lip gloss.
"She walked with the universe on her shoulders and made it look like a pair of wings," the obituary continued. "However stealthy and vicious the cancer was, it did not succeed in diminishing the wonderful memories."
The family asked that donations be made to the Viviana Ruscitto Memorial Fund, c/o Hannemann Funeral Home, 88 South Broadway, Nyack, NY 10960.
Besides her son, Ruscitto is survived by her parents, Umberto and Esther Ruscitto of Nyack, her sister Mirian Rivera and brother-in-law John; and her brother Umberto.
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WSJ: Feds to launch power morcellator probe aimed at FDA
Sep 11, 2015 | Fierce Medical Devices
By Emily Wasserman
The FDA has been getting it from all sides lately for its oversight of power morcellator devices, with lawmakers last month urging the U.S. Government Accountability Office (GAO) to probe the agency's regulation of the products. Now, the GAO is planning to take on the charge and launch an investigation into the devices.
"We've agreed to do the work," Katherine Siggerud, managing director for congressional relations at the GAO, told The Wall Street Journal. Last month, a bipartisan group of 12 lawmakers including Rep. Mike Fitzpatrick (R-PA) and Rep. Louise Slaughter (D-NY) sent a letter to the agency asking it to look into the FDA's morcellator regulation. Regulators have cleared at least 10 power morcellators for sale since the first one launched 24 years ago, the lawmakers said in their note.
And even though the FDA has flagged morcellators' risk of spreading undetected cancer, its warning came "decades after some studies were already pointing to a serious problem," lawmakers said, as quoted by the WSJ.
The GAO is staying mum on details of the probe, with Siggerud telling the newspaper that it is too soon to tell how long the investigation will take. An FDA spokesman said the agency will cooperate with any GAO review but that it does not comment on pending or ongoing investigations, the WSJ reports.
The probe turns up the heat on the FDA, which is facing its fair share of scrutiny over power morcellator devices. Last year, the agency issued a warning against using laparoscopic power morcellator tools in minimally invasive surgeries to remove uterine fibroids, saying there was a one in 350 risk of uterine sarcoma in women undergoing procedures with the tools. Before regulators issued their warning, the device was used in about 50,000 U.S. uterine surgeries each year.
The FDA warning prompted backlash, with Johnson & Johnson ($JNJ)--the world's largest maker of the devices--pulling its product from the global market in July 2014. In November, the FDA stepped up its oversight of the products, slapping the devices with a black box and recommending against using them in the "majority" of women undergoing a hysterectomy or uterine fibroid removal.
Still, the move has not done much to appease industry groups and patients. Private health insurers including Aetna ($AET) and UnitedHealth ($UNH)--the largest insurer in the U.S.--have curtailed coverage for power morcellator devices since the FDA released its warning. And some experts argue that the fallout points to a bigger problem, as the agency approves too many moderate- and high-risk devices without proper evidence.
But the FDA is standing by its regulation, saying that 510(k) clearance allows it to balance "innovation and safety," Dr. William Maisel, the agency's chief scientist, told the WSJ last year. The agency has stopped short of banning power morcellators altogether, saying the devices' benefits may outweigh the risks in some women.
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Medical landscape ‘continuing to evolve’ after FDA guidance about power morcellation
Sep 10, 2015 | Healio
By Jennifer Southall
The FDA issued guidance last fall about the use of laparoscopic power morcellation for treatment of uterine fibroids.
The agency warned against use of the technique during most myomectomies and hysterectomies due to the potential that it could spread undetected uterine sarcomas.
“[Since then], things are continuing to evolve in the medical landscape, and practitioners and industry are all looking into how to make this procedure safer for patients within the guidelines that the FDA has established,” Jubilee Brown, MD, associate professor in the department of gynecologic oncology and reproductive medicine at The University of Texas MD Anderson Cancer Center, said in an interview.
HemOnc Today spoke with several experts to assess what has changed since the FDA issued its guidance, and how the clinical and research communities have responded to the warning.
New approaches
During power morcellation, a tiny instrument with a rapidly rotating blade grinds up uterine fibroids — or benign tumors within the uterus — and allows for their removal via a laparoscope.
The procedure allows for a smaller incision, quicker recovery period, fewer side effects and lower rate of morbidity than more invasive open surgeries.
In November 2014, the FDA issued “immediately in effect” guidance that warned against the use of power morcellators in hysterectomies and myomectomies.
The FDA estimated that approximately 1 in 352 women who undergo hysterectomy or myomectomy for presumed benign fibroids has an unsuspected uterine cancer, and that 1 in 498 has an unsuspected leiomyosarcoma. Other research, however, has questioned whether risks are that high, particularly for myomectomy.
In its guidance, the FDA recommended manufacturers of laparoscopic power morcellators include a boxed warning to acknowledge the risk that undetected leiomyosarcomas or other malignancies within uterine tissue can be disseminated throughout a woman’s pelvic and abdominal cavities during morcellation, increasing risks for morbidity and mortality.
The guidance also recommends morcellators be contraindicated for women who are peri- or postmenopausal, those who are candidates for en bloc tissue removal through the vagina or mini-laparotomy incision, and patients in whom the tissue to be morcellated is known or suspected to be cancerous.
Shortly after the FDA issued the guidance, Johnson & Johnson — a leading manufacturer of power morcellators — removed its products off the market. Several large institutions, including Brigham & Women’s Hospital and Cleveland Clinic, stopped performing laparoscopic power morcellation.
“Most organizations are limiting morcellation … and there are only a few morcellators on the market now,” David Mutch, MD, professor of obstetrics and gynecology and division chief of gynecologic oncology at Washington University School of Medicine in St. Louis, told HemOnc Today. “Use of the power morcellator has declined without question, and I think this is the right way to go.”
Despite its recommendation for a black box warning and contraindications, the FDA did not ban the procedure. Consequently, investigations into alternative means of performing power morcellation are underway.
“In order to continue with minimally invasive surgery and all of the benefits that it entails for our patients, we are looking at safer ways to accomplish the procedure,” Brown said. “Part of this is patient selection, and part of this is improving upon the devices that we already have available.”
Several companies also are looking at new devices that safely accomplish this, Brown said.
“There is still great interest in trying to understand if there are cases where the morcellator is beneficial, and there is ongoing research examining other tissue extraction methods, such as placing the uterus in a bag and morcellating within the bag, Jason D. Wright, MD, chief of the division of gynecologic oncology and associate professor of obstetrics and gynecology at Columbia University Medical Center, told HemOnc Today.
Researchers at Washington University conducted a study to assess this alternative technique, known as contained morcellation. The data are expected to be published in Obstetrics & Gynecology, Mutch said.
“Even if the use of power morcellation comes back, informed consent from the patient is needed, which is something we were not doing much of before,” Mutch said.
Impact on payers
Although the FDA did not ban power morcellation, several hospitals and health care systems across the country stopped performing the procedure and many insurance companies have restricted coverage.
In May, Aetna implemented a new policy on the use of power morcellation for the removal of uterine fibroids. Myomectomy and hysterectomy procedures that use a power morcellator are no longer covered for most circumstances.
Although the reactions Aetna received from physicians are mostly supportive, Aetna has a process that allows for consideration of clinical exceptions in cases when physicians believe power morcellation is the best option for patients, according to B. Kathy Skipper, senior communications consultant for health and wellness with Aetna.
“Aetna requires doctors to precertify myomectomies or hysterectomies that use a power morcellator,” Skipper told HemOnc Today. “The policy takes into account the latest FDA warnings about the risk that morcellation can spread unsuspected uterine sarcoma in the abdomen and pelvis. Aetna is encouraging physicians to talk to patients about the risks and benefits of morcellation and the alternatives.”
Other insurance companies have not changed their policies. Health Care Service of America Corp. announced in June it will continue to cover power morcellation.
“I know that certain health insurance companies have made statements saying they will not cover hysterectomies that include morcellation,” Wright said. “I also know there are several insurers that are still reviewing the procedure and technology and continue to cover it. [The FDA’s guidance] has definitely impacted payers, and we will probably see more [changes] within the next few months.”
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Report: Feds to investigate power morcellators
Sep 11, 2015 | Mass Device
By Fink Densford
The Government Accountability Office said last week it will investigate potential safety and regulatory issues with laproscopic power morcellators, according to The Wall Street Journal.
The devices use small, rotating blades to break up large tissue masses into fragments, and are commonly used to remove uterine fibroids in women. However, if the device is used on a patient with an undetected cancerous growth, it can enable the cancer to spread, according to the FDA.
The tools have been under the scrutiny of the FDA for over a year – last November, the agency released a security communication warning that women undergoing hysterectomies or myomectomies using power morcellators faced 1 in 350 odds of having an undetected cancer that could significantly worsen through the treatment.
“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,” the agency wrote in their warning letter.
The Wall Street Journal said the GAO has agreed to take up the torch, stating the agency was likely to have staff to investigate the devices, their regulatory approval and other issues within 5 months.
The investigation was prompted by a letter signed by 12 members of congress who wanted the group to probe the use and clearance of the devices. The letter requested an investigation into the FDA’s handling of the devices, how it’s ensuring their safety and what it is doing to ensure the still-commercially-available devices aren’t causing harm, according to the paper.
Last July, An FDA panel convened to consider the use of power morcellators in fibroid removal in hopes of coming to a clear decision on the cancer risk from the devices, despite outraged testimony from dozens of attendees.
The 15-member panel offered several suggestions for mitigating the risk of spreading uterine sarcomas in using the morcellators, including an outright ban, stricter product labeling and limiting use in some patient populations.
The panel urged surgeons to take precautions including MRI, radiologic imaging and biopsy and to take patient age and exam findings into account to ensure a fibroid is not cancerous prior to removal. Peri-menopausal and post-menpausal women should definitely not have morcellation, they said. The committee also called for enhanced warnings to surgeons and increased communication to ensure that patients know there is a small but grave risk associated with the use of laparoscopic surgery and the use of LPMs and that other options, such as more invasive abdominal surgery, are available.
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MIS Procedures Decrease After FDA Guidelines
Sep 11, 2015 | Michigan Health System
Since the Food and Drug Administration (FDA) cautioned against using a minimally invasive method to treat fibroid tumors called power morcellation, there was a nearly quarter increase in hospital readmissions and 27 percent increase in major postoperative complications after hysterectomies in Michigan, a new University of Michigan study says.
After the first FDA safety communication in April 2014, the percent of women receiving minimally invasive hysterectomies in a large Michigan database also went down by an absolute 1.7 percent decrease. The findings appear in the American Journal of Obstetrics & Gynecology.
Laparoscopic power morcellation is a minimally invasive method of removing fibroid tumors from the uterus or removing the entire uterus by fragmenting it into smaller pieces. The FDA guidelines followed concerns that the technique could potentially spread unsuspected tumors that appeared as benign fibroids.
"We know that for a significant number of women, a minimally invasive procedure that avoids the risks of surgery is a viable option and often the safest. Since the FDA communication, we saw a decrease in minimally invasive hysterectomies," says John Harris, M.D. M.Sc., a Robert Wood Johnson Foundation Clinical Scholar in the U-M Department of Obstetrics and Gynecology and member of the Institute for Healthcare Policy and Innovation.
"We found that since the FDA communication, the risk of postoperative complications for women undergoing hysterectomies actually increased. We did not examine the underlying cause for these changes, but it is associated with the FDA communication on morcellation and cancer risk."
Researchers analyzed 18,299 hysterectomies during the study period and compared data from the 15 months preceding the FDA safety communication to the eight months afterwards.
The study did not examine any outcomes around diagnosis of occult cancer or the rate of morcellation surgeries. The study also did not compare whether the same patient is more or less likely to receive a more invasive technique, however findings suggest that women in Michigan are less likely to have a minimally invasive method for hysterectomy after the FDA safety communication.
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Treatment For Fibroid Tumors Raises Risk Of Spreading Cancer
Sep 14, 2015 | Vocativ
By Tracy Clark-Flory
A new study adds fuel to an ongoing debate over women’s healthcare: if a surgical procedure associated with dramatically fewer post-operative complications puts some patients at risk for life-threatening cancer, is it worthwhile?
That’s the question at the heart of a battle over morcellation, a laproscopic procedure often used for hysterectomies in which uterine tissue is cut up and removed through a small incision. Proponents of the procedure argue that it is safer than alternative approaches to hysterectomy that are more invasive. But the fact remains that if a woman undergoing the procedure has a cancer that has not been detected, the cutting process can also pick up and spread that cancer and decrease that woman’s chances of survival. That’s why the Food and Drug Administration issued an advisory last year against using the procedure for hysterectomy in women with fibroids.
Now, a study out of the University of Michigan shows that post-operative complications in hysterectomies grew significantly following that FDA alert. Hospital readmissions went up by a quarter and there was a 27 percent jump in major surgical issues, excluding blood transfusions, following hysterectomies. At the same time, the number of morcellation hysterectomies decreased by 4.1 percent and vaginal and abdominal hysterectomies increased by 1.7 and 2.4 percent, respectively. (It’s interesting to note that the decrease in morcellation was among all women undergoing hysterectomies, despite the FDA advising against using the procedure specifically on patients with fibroids.)
This seems to speak to the benefits of morcellation over other hysterectomy procedures—but it’s important to note that the study was not designed to measure those relative risks. Instead, it looked at how FDA advisories impact doctors’ and patients’ decisions about treatment. Still, study author John Harris says the results do tell us something about hysterectomy risk in the wake of the FDA’s advisory.
“There are relatively rare amount of people that are ever going to have an occult sarcoma”— essentially, cancer in disguise—“but every woman that is facing a decision to have a hysterectomy now is generally exposed to slightly more risk,” says Harris, a scholar at the University of Michigan’s Department of Obstetrics and Gynecology. This research builds on a recent study comparing outcomes for fibroid-related hysterectomies done through morcellation versus abdominal surgery. It found that the latter had a greater risk of complications, decreased quality of life and death.
As for the risk of morcellation spreading undetected cancer, the study points to recent research finding that the prevalence of “occult sarcoma” is between 0.07 and 0.49 percent. Similarly, the FDA found that one in 350 women undergoing fibroid-related hysterectomy or myomectomy, which leaves the uterus intact, has unexpected uterine cancer.
As the morcellation debate shows, the cost-benefit analyses done around medical procedures are often extremely tricky. “It’s a cacophony of confusing signals in which it’s hard to hear a clear message about what makes one device stay available, one drug get pulled, one vaccine encouraged, one biologic not yet yanked off the market,” says Arthur Caplan, head of the Division of Medical Ethics at New York University. “It’s not like a system where you can sort of say, ‘Uh oh, if you get above five deaths and you’re saving 3,000 lives, well, that’s it.'”
“With all things, until you get more studies that reconfirm, you wouldn’t want to flip policy just on this,” he says. “But it certainly would make you want to look harder.”
Hooman Noorchashm became a leading activist against morcellation after his wife underwent the procedure and developed an aggressive form of uterine cancer. He’s also a cardio-thoracic surgeon and attributes the rise in complications documented in this study to poor training in gynecology. “If that group of surgeons is not adept at doing open operations, of course the complication rates are going to go up,” he says. “We have a generation of gynecologists who have trained to do morcellation and who now are faced with the prospect of not being able to do it anymore. They’re out of their comfort zone.”
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GAO to Investigate Power Morcellation Harms
Sep 11, 2015 | The Cancer Letter
By Matthew Bin Han Ong
The U.S. Government Accountability Office said it would investigate the controversy stemming from wide use of power morcellators, gynecological devices now known to spread undetected cancers during hysterectomies and myomectomies.
The GAO’s Sept. 4 move comes after 12 members of Congress wrote a letter requesting an investigation.
“Hundreds, if not thousands, of women in America are dead because of a medical device known as a laparoscopic power morcellator,” the legislators said in the letter Aug. 7. “This device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. For too many women, this routine procedure ended with a death sentence.”
The letter was signed by Reps. Mike Fitzpatrick (R-Pa.), Louise Slaughter (D-N.Y.), Ralph Abraham (R-La.), Rosa DeLauro (D-Conn.), Bill Pascrell, Jr. (D-N.J.), Lou Barletta (R-Pa.), Doug LaMalfa (R-Calif.), Anna G. Eshoo (D-Calif.), Jan Schakowsky (D-Ill.), Chris Smith (R-N.J.), Stephen Lynch (D-Mass.), and Rick Larsen (D-Wash.).
FDA severely limited the use of power morcellators in November 2014, a year after patient advocates Amy Reed and Hooman Noorchashm launched a vigorous campaign that drew FDA’s attention to the issue (The Cancer Letter, Nov. 26, 2014).
The GAO investigation comes on the heels of an FBI probe in May. The FBI is reportedly trying to establish whether Johnson & Johnson—one of the largest manufacturers of power morcellators—knew as early as nine years ago that the gynecological device can disseminate uterine cancers (The Cancer Letter, May 29).
It’s not publicly known whether a formal FBI investigation has been launched.
The 12 lawmakers appear to be asking the same questions:
“Despite the long history of this device, only recently has the FDA put out guidance that the use of laparoscopic power morcellators increases the risk of spreading unsuspected cancers in women to as high as 1 in 352 cases,” they wrote in the letter to GAO. “As of the date of this letter, the morcellator remains on the market.
“It is unclear exactly how many women may be dead as a result of an unsuspected cancer having been spread by this device. FDA’s warning came decades after some studies were already pointing to a serious problem.
“Despite these studies, as late as last year, the FDA, the medical device industry, and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-10,000.
“How did they get it wrong for so long?
“In light of these concerns we respectfully request you investigate the root cause failure that ultimately led to the FDA’s black box warning on the use of laparoscopic power morcellators in Nov. 2014—over two decades after it was first approved.”
The legislators asked GAO to consider four questions:
1. Did the FDA’s reliance on the 510(k) approval policies and procedures sufficiently identify risks of adverse events before the laparoscopic power morcellator was allowed to enter the market?
2. Were the medical device reporting regulations (21 CFR 803) appropriately followed to protect patient safety in the case of the laparoscopic power morcellator by manufacturers, importers, user facilities, and the FDA?
3. What activities or training did manufacturers provide to clinicians and what professional society standards, if any, apply to training on the use of these devices?
4. What steps is the FDA taking after issuing the black box warning to further determine whether the laparoscopic power morcellator is safe to remain on the market?
The work requested by the members of Congress falls within the scope of GAO authority, a GAO spokesperson said to the Wall Street Journal. The investigation should begin in about five months, and FDA has agreed to cooperate.
The Congressional letter to the GAO can be found here.
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Michigan Woman Files Power Morcellator Lawsuit
Sep 11, 2015 | The Legal Herald
By Laurence Banville
Karl Storz Endovision Inc. find themselves named as the defendants in a power morcellator lawsuit filed on January 26th, 2015 in the U.S. District Court for the Eastern Division of Michigan under case number 2:15-cv-10352-TGB-APP. This is just one of many lawsuits which have been filed against companies who manufacture power morcellators.
A Michigan woman, who underwent surgical procedures known as a laparoscopic supracervical hysterectomy and bilateral salpingectomy to treat her uterine fibroids on June 14th, 2011, alleges that she is now battling stage-4 cancer due to the use of a power morcellator.
During her surgery, the doctor used a Rotocut GI power morcellator to cut and remove the uterus. On July 14th, 2014, she was admitted into the hospital for spinal surgery, but at that time it was discovered that she had developed stage-4 breast and bone cancer.
Per the lawsuit, she has “had to undergo extensive and intensive therapies for the treatment and management of her advanced-stage cancer. This treatment includes daily hormone medications, regular injections of medications by her physicians, and multiple ten-week rounds of radiation therapy.”
How the Morcellator Works
When the morcellator is used in laparoscopic surgeries, the device is inserted into the abdominal cavity via a small incision. The morcellator consists of a hollow cylinder that ends with cutting jaws. A “grasper” can also be inserted into the hollow portion of the cylinder.
Once in the abdomen, the morcellator’s cutting jaws slice through unwanted tissue so that the grasper can pull the tissue out through the cylinder. Laparoscopic surgeries are minimally invasive procedures and allow for a quicker recovery time for the patient.
However, the public and medical community were unaware of the risks associated with using the power morcellator in gynecological surgeries. The majority of hysterectomies and myomectomies are performed when the patient is suffering from enlarged uterine fibroids. While most fibroids are benign, the U.S. Food and Drug Administration has reported that around 1 in 350 women who undergo these surgeries also has undiagnosed uterine cancer.
When the cutting jaws of the morcellator shred a uterine fibroid containing uterine cancer, there is a risk that the cancer cells will disseminate throughout the abdominal cavity and take root, resulting in the metastasis of the cancer outside of the uterus.
In the Michigan lawsuit the plaintiff is alleging that “despite the fact that evidence existed that the use of Rotocut GI power morcellator was dangerous and likely to place users at serious risk to their health, the defendants failed to disclose and warn of the health hazards and risks associated with the Rotocut GI power morcellator and in fact acted to deceive the medical community and public at large, including all potential users of Rotocut GI power morcellator by promoting it as safe and effective for its intended use.”
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Power Morcellator Lawsuit – A Look Back At The First Five Plaintiffs
Sep 10, 2015 | The Legal Herald
By Laurence Banville
The power morcellator: initially this surgical tool was thought to be a wondrous invention that would bring about a new era of non-invasive laparoscopic surgery. Approval was granted by the U.S. Food and Drug Administration under a 501(k).
When a device is given approval under a 501(k), it is reviewed by the FDA’s Center for Devices and Radiological Health (CDRH). Any devices reviewed by this department do not have to undergo rigorous safety testing, as long as it can be shown that the device is “substantially equivalent” to a previously approved device. Devices that need to be evaluated before approval are researched by an entirely different department, the FDA’s Center for Drug Evaluation and Research.
Since the instrument first hit the market, it has been used in countless laparoscopic surgeries, including procedures such as hysterectomies and myomectomies. In most cases, a doctor will recommend that a woman has a hysterectomy or myomectomy performed because of uterine fibroids which are causing the uterus to expand to the point of pain or bleeding.
Unfortunately, as we have come to see, the use of a power morcellator during these procedures carries the great risk of the potential spread of undetected uterine cancer.
The First Five Lawsuits
Tracey & Fox reported on the first power morcellator lawsuit which was filed on March 14th, 2014 in the U.S.District Court for the Eastern District of Pennsylvania under case number 5:14-cv-1557. This lawsuit is both a negligence and wrongful death suit, filed by the widower of a woman who died after being diagnosed with leiomyosarcoma nine days after she underwent a laparoscopic hysterectomy performed using a power morcellator.
One month after this lawsuit was filed, the FDA released a safety warning regarding the use of power morcellators during gynecological surgeries, indicating that if the patient has undetected uterine cancer there is a chance the morcellator could spread those cancer cells to other areas of the body.
On May 1st, 2014, the second lawsuit was filed by a woman who only lived for another five months before passing away. Her widower has chosen to continue pursuing the complaint after her death. This lawsuit alleges the plaintiff had uterine cancer that was “upstaged” by the use of a power morcellator and resulted in stage 4 cancer. She was treated with both chemotherapy and radiation. This case is filed in the U.S. District Court for the Western District of New York under case number 6:14-cv-06218.
A few days later on May 13th, 2014, the third case was filed in the U.S. District Court for the Northern District of California under case number 5:14-cv-02209-EID. In May of 2012, the plaintiff had a hysterectomy performed to remove what she thought were benign fibroids. After her surgery she was informed that one of the fibroids contained leiomyosarcoma. Despite being treated with aggressive therapy she has now developed four lesions on her lungs thought to be metastatic leiomyosarcoma.
The fourth complaint came on October 9th, 2014. It was filed under case number 2:14-cv-02375-GEB-DAD in the U.S. District Court for the Eastern District of California. In this case, the plaintiff alleges that she was not “informed that the use of a power morcellator presents a risk of spreading undetected cancers.” After her hysterectomy, seven new cancerous tumors were found throughout her abdomen. Doctors suspect the cancer metastasized because the cancer cells were spread by a morcellator.
The fifth lawsuit came on January 26th, 2015 under case number 2:15-cv-10352-TGB-APP in the US District Court for the Eastern District of Michigan. In this case a woman claims she is now fighting uterine cancer that spread to her breasts and bones because of the power morcellator. She states that the morcellator is “unreasonably dangerous” and “defective in design.”
Of the first five lawsuits, only the first lawsuit has been settled for an undisclosed amount. The remaining four are scheduled to go to trial.
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