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Morcellation Media Monitoring 08/13/2015
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Fighting for her life: Woman says routine surgery caused her cancer
Aug 13, 2015 | Fox News (TV) Clip
By Fox and Friends
View clip here: http://beta.criticalmention.com/app/#clip/view?15105994/token/6dac0be0-eb27-4576-8fcc-eb6c213ceb50 Rough transcript: she went in for a routine hysterectomy. now a mom is fighting for her life. she says the device made cancer spread throughout her body. she's suing the makers of the device, the hospital and doctors. what happened and could this happen to you? doctor, this is an awful story. fda released the statement and said approximately one in 350 women undergoing hysterectomy is said to have an undocumented sarcoma. it significantly increases the risk of patient's likelihood of survival. -
Deadly harm: The result of regulatory failure by FDA
Aug 12, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
On Monday, August 10, 2015 a young mother, Viviana Ruscitto, lay dying at a New York Hospital - her abdominal cavity filled with inoperable cancerous tumors blocking her intestines. Her toddler’s life was forever changed. You can read her account here. She was another apparent victim of a gynecological device, known as a “power morcellator”. -
The 'Fitzpatrick 12' in U.S. Congress: A bipartisan call for FDA accountability on medical device safety
Aug 10, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
On Friday August 7, 2015 a letter from the United States Congress, was delivered to the attention of the Comptroller General of the United States, Mr. Gene Dodaro – head of the Government Accountability Office (GAO). The letter was a formal request for the Comptroller General to initiate a GAO investigation into the root causes of a disaster in women’s health. This disaster was caused, in great part, by the FDA’s careless clearance and absent post-market surveillance of a medical device known as a “power morcellator”. -
From hospital bed, cancer patient presses device suit that blames N.J. doctors, manufacturer
Aug 10, 2015 | The Record
By Lindy Washburn
Viviana Ruscitto, the mother of a toddler, is fighting for her life in a New York hospital bed. She is suffering from a highly aggressive form of cancer that, she believes, was spread by a device used during what was supposed to be a routine hysterectomy. A surgical tool called a power morcellator was used to cut and shred tissue so it could be sucked out through a tiny opening during the minimally invasive operation. Ruscitto, 43, believes it spattered cancer cells through her abdomen. -
Routine Procedure At N.J. Hospital Allegedly Spread Cancer in Woman's Body
Aug 13, 2015 | Ridgewood-Glen Rock Patch
By Tom Davis
A woman suffering from an aggressive form of cancer is suing a New Jersey hospital for using a potentially dangerous device that she says spread cancer cells through her body during what was supposed to be a routine hysterectomy. Viviana Ruscitto, 43, the mother of a toddler, said a power morcellator was used to cut and shred tissue so it could be sucked out through a tiny opening during the minimally invasive operation. During the procedure, it spattered cancer cells through her abdomen, according to The Record of Bergen County. -
Congress urges feds to probe FDA over morcellator safety concerns
Aug 10, 2015 | Fierce Medical Devices
By Emily Wasserman
The FDA has faced its fair share of scrutiny over power morcellators, with the public and advocacy groups claiming that the agency took a backseat in regulating the devices. Now Congress is weighing in on the issue, urging the federal government to investigate the FDA's approval process and monitoring of the tools. -
Lawmakers Ask GAO to Investigate Power Morcellators
Aug 11, 2015 | MedScape
By Robert Lowes
Twelve members of Congress asked a federal watchdog agency last week to investigate why the US Food and Drug Administration (FDA) took so long to warn that power morcellators may spread unseen cancers in the course of removing uterine fibroids. "Hundreds, if not thousands, of women in America are dead" because of these devices, the bipartisan group of lawmakers wrote in an August 7 letter to the US Government Accountability Office (GAO). -
FDA's Handling of Morcellators Gets Scrutiny from Congress
Aug 11, 2015 | Qmed
By Nancy Crotti
A dozen members of Congress have asked the federal government to investigate FDA over its regulation of power morcellators. It turns out that the devices, used for 24 years in the U.S. to slice up tissue during laparoscopic hysterectomies and myomectomies, can also potentially spread cancer in women. -
Power Morcellators are Killing Women: DOJ Finally Investigates
Aug 11, 2015 | Ring of Fire
By KJ McElrath
The laproscopic power morcellator is just the latest in a long line of medical devices that have wound up doing far more harm than good – and that were given rapid and ill-advised approval by the US Food and Drug Administration (FDA). That same federal agency finally issued a warning in late November of 2014 – but only after thousands of women died unnecessarily from what was supposed to be a minor procedure. No actual warning has been issued, however, and many morcellators are still in use. Last week, twelve members of Congress from both parties signed a letter to the Government Accountability Office (GAO) demanding an investigation. -
Government Accountability Office Asked to Investigate FDA’s Handling of Surgical Tool’s Risks
Aug 12, 2015 | News Inferno
By F.A. Kelley
Twelve members of Congress have asked the Government Accountability Office (GAO) to investigate why a device used in gynecologic surgery was marketed for two decades before safety warnings were issued by the Food and Drug Administration (FDA). The power morcellator allows fibroid surgeries and hysterectomies to be done through small incisions rather than large abdominal incisions, but the device can also spread and worsen undetected uterine cancer, Philly.com reports.
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Fighting for her life: Woman says routine surgery caused her cancer
Aug 13, 2015 | Fox News (TV) Clip
By Fox and Friends
View clip here: http://beta.criticalmention.com/app/#clip/view?15105994/token/6dac0be0-eb27-4576-8fcc-eb6c213ceb50
Rough transcript: she went in for a routine hysterectomy. now a mom is fighting for her life. she says the device made cancer spread throughout her body. she's suing the makers of the device, the hospital and doctors. what happened and could this happen to you? doctor, this is an awful story. fda released the statement and said approximately one in 350 women undergoing hysterectomy is said to have an undocumented sarcoma. it significantly increases the risk of patient's likelihood of survival.
>> what you mentioned, one out of 350 women that go for hysterectomy, removing fibroids may end up having the cancer spread. it sounds like a small number. when you do 600,000 a year in this country, those numbers add up. there's lawsuits in the country. women that have pelvic pain, may have fibroids, benign growth. they have to go for hysterectomy, and most go and remove it with no problems because it comes out. now with surgeries you can't remove it through the holes. as a result on e out of 350 women, if there's cancer in the uterus, it can spread. this is an example of a morcellator, you can grab the tissue and bring it through and chop it off. unfortunately once the cancer starts to spread, women have stage four disease. you take something simple into a nightmare. we've seen an example of this woman Amy Reed with six kids. my heart goes to these people. it's unfortunate. the way it should be done -- of course there's opinion with a lot of doctors. i do robotic surgery for prostate cancer. i do it everyday. the way is not chopping it off or cutting it. i use a simple basket. basically, once the organ is removed, whether gallbladder, prostate or colon. put it in this nylon basket. the organ goes in here. they can you can basically pull the string and lock it up.
>> it's contained.
>> it's contained. that's the key word. once you chop it off, you don't get sizing. when you chop it, it can spread.
>> as a patient, can you refer or tell them i prefer you use this to keep it from spreading?
>> a lot of hospitals, if you're still using the morcellator, that's a big mistake. ask questions. are you still using a morcellator? always go for doctors who have high volume and good outcome and have a discussion. make a decision. big message to a lot of people. we hope even though these stories are nightmares, i hope it helps other other women out there.
>> i pray it does.
>> we'll post information on facebook and twitter.
>> thanks.
>> of course.
>> we did reach out to the hospital and device maker but did not hear back. thanks for the wisdom today.
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Deadly harm: The result of regulatory failure by FDA
Aug 12, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
On Monday, August 10, 2015 a young mother, Viviana Ruscitto, lay dying at a New York Hospital - her abdominal cavity filled with inoperable cancerous tumors blocking her intestines. Her toddler’s life was forever changed.
She was another apparent victim of a gynecological device, known as a “power morcellator”.
According to North Jersey’s The Record, this woman’s gynecologist, Dr. Howard H. Jones, used a power morcellator manufactured by Karl Storz Co. to mince up her uterus for the purpose of performing a minimally invasive operation. This technique most likely spread her contained, early stage cancer to an advanced disseminated stage IV cancer.
The trouble is that this complication was not simply an unavoidable medical error. It was not an “oops” moment in surgical practice.
According to The Record, Viviana’s surgery took place on October 17, 2014.
The tragic significance of this date is that it came a full year, to the day, after our family’s well-publicized complication with this exact device at the Brigham and Women’s Hospital in Boston.
But it wasn’t just that the doctor and hospital ignored the large-scale publicity between October 17, 2013 and October 17, 2014 in their decision algorithm.
In April 2014, the Food and Drug Administration put out a safety advisory to clinicians and doctors regarding the oncological risk of power morcellation.
In July 2014, the FDA held a well-publicized hearing to assess the dangers of power morcellation. And in the same month, the largest manufacturer of the power morcellator withdrew the product from the marketplace due to significant “safety concerns”.
So Viviana’s surgery was performed one full year after we, and the WSJ reporters Jennifer Levitz and Jon Kamp, presented the public and FDA with undeniable evidence of deadly harm from cancer upstaging by morcellation. Six months after the FDA released a warning that these tools should be used with extreme caution. And three months after Johnson & Johnson had withdrawn from the morcellator market.
This doctor, his hospital, Karl Storz Co. and the FDA all could and should have protected this young mother’s life – and the many others who remain in harm’s way.
When Dr. Jones chose, in spite of the FDA’s warnings and publicity, to use a power morcellator, he made an incorrect and deadly assumption for his patients. He not only devastated his patient but also her entire family, including her toddler, who will now grow up without a mother.
Clearly, Dr. Jones and his hospital were either unaware of, or chose to ignore, the massive level of publicity, the FDA warning and J&J’s action - but why?
Clearly, Karl Storz Co., the manufacturer of the power morcellator did not pay adequate attention. Even now they are continuing to manufacture and sell this product in the United States - but why?
Despite the overwhelming scientific and epidemiological data, the FDA’s Center for Devices and radiological Health (CDRH) failed to ban this product from the market in November 2014.
There are only two possible explanations to “why” Viviana Ruscitto and her family are in the tragic position they are in: arrogance or ignorance on the professional and corporate levels.
As for the FDA’s CDRH, Viviana Ruscitto’s case should serve as a warning to all federal investigators and the United States Congress. Because this tragedy is what happens when our federal agencies fail at the due diligence they owe the public and its safety.
The CDRH’s failure to ban power morcellators in November 2014, despite overwhelming evidence of harm, is demonstration of unacceptable “mission-corruption” at that agency. That agency’s purpose is not to streamline with device manufacturers and medical professionals or to operate on the assumption that corporate entities are equal stakeholders with the public - it is ONLY to keep patients and the public safe.
In the end, our federal government must turn Viviana Ruscitto and others like her into icons and guardians defending and protecting others from deadly harm - from the forces of arrogance, ignorance and mission-corruption in our healthcare establishment, in our corporations and in our public health agencies.
Our prayers and respect go to Viviana Ruscitto and her family for their unsolicited bravery in the face of what can only be described as a case of unforgivable negligence.
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Aug 10, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
On Friday August 7, 2015 a letter from the United States Congress, was delivered to the attention of the Comptroller General of the United States, Mr. Gene Dodaro – head of the Government Accountability Office (GAO).
The letter was a formal request for the Comptroller General to initiate a GAO investigation into the root causes of a disaster in women’s health. This disaster was caused, in great part, by the FDA’s careless clearance and absent post-market surveillance of a medical device known as a “power morcellator”.
The faces of harm by this device are clearly before our federal government. You can view the harmed here - they are the “guardians” whose battles will serve to protect all others in harm’s way, present and future.
The bipartisan letter of August 7 to Mr. Dodaro was signed by twelve representatives in the United States Congress, and was spearheaded by Rep. Mike Fitzpatrick (R-PA) and Rep. Louise Slaughter (D-NY).
Representatives Fitzpatrick and Slaughter, both of whom have constituents with medical issues due topower morcellation, clearly see their responsibility to the American people to fix FDA’s broken regulatory framework governing medical device safety.
In their letter to the comptroller general, the “Fitzpatrick twelve” asked the GAO to consider the following questions in their investigation:
1) Did the FDA’s reliance on the 510(k) approval policies and procedure 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?
At a time when the United States Congress is characterized by partisan bickering, this request for a GAO investigation demonstrates that our representatives can work to identify and eliminate threats to America’s health and wealth.
We hope to confirm the initiation of an investigation by the nonpartisan GAO in the next few weeks. But, there remain no guarantees that even a GAO investigation will prompt Congress into action.
We, and many other concerned and affected citizens, applaud the “Fitzpatrick twelve” for their tenacious action on behalf of America’s public health. But more importantly, we ask why more of their informed colleagues have not joined them in calling for this GAO investigation – if for nothing else, to understand the root causes of a deadly harm done to many American women and their families for over two decades.
Prominent and powerful names such as Congressman Joe Pitts (R-PA), chair of congress’ subcommittee on health, and Congressman Fred Upton (R-MI), chair of the committee on Energy and Commerce, know about the “power morcellator” disaster in women’s health, yet have not supported the investigation.
We know that if a GAO investigation is done properly and with care, it will provide information and insight into a wide-scale and severe public health threat – one, which no congressional representative can justify ignoring.
For now, our hats are off to the “Fitzpatrick twelve” for standing outside of party politics and looking for reason, ethics, integrity and justice - and aiming to protect the public with resolve: Mike Fitzpatrick (R-PA), Louise Slaughter (D-NY), Ralph Abraham (R-LA), Rosa DeLauro (D-CT), Bill Pascrell (D-NJ), Lou Barletta (R-PA), Doug LaMalfa (R-CA), Anna Eshoo (D-CA), Jan Schkowsky (D-IL), Chris Smith (R-NJ), Stephen Lynch (D-MA), and Rick Larsen (D-WA).
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From hospital bed, cancer patient presses device suit that blames N.J. doctors, manufacturer
Aug 10, 2015 | The Record
By Lindy Washburn
Viviana Ruscitto, the mother of a toddler, is fighting for her life in a New York hospital bed. She is suffering from a highly aggressive form of cancer that, she believes, was spread by a device used during what was supposed to be a routine hysterectomy.
A surgical tool called a power morcellator was used to cut and shred tissue so it could be sucked out through a tiny opening during the minimally invasive operation. Ruscitto, 43, believes it spattered cancer cells through her abdomen.
In a lawsuit filed in federal court in Newark, she contends it should never have been used for her surgery at The Valley Hospital in Ridgewood last fall. Six months before her operation to remove a large fibroid, the federal government had discouraged health-care professionals from using morcellators because of the risk of spreading undetected cancer cells. The largest manufacturer of the device had already suspended sales.
“My sister’s prognosis is poor, and I do not know how much longer she can continue fighting this cancer that is attacking her body so fiercely,” Mirian Rivera told a judge last week in a sworn statement. “Our mother and I take turns staying with her at the hospital, while our father is at home taking care of her 2-year-old son, Maximo.”
Ruscitto has been diagnosed with Stage 4 leiomyosarcoma, a rare and aggressive cancer.
She has sued the device maker, her doctors and Valley, charging that they should have known about the risk posed by the device.
A judge in federal district court agreed last week to her attorney’s request to take her testimony immediately — in her room at Memorial Sloan Kettering Cancer Center, if necessary. She may not live to attend the trial, the attorney, Demetrios Stratis, said.
The metastases have spread quickly, obstructing her intestines and causing so much swelling she looks nine months pregnant, Rivera told the court. Ruscitto, who lives in Upper Nyack and has been the radiology director of a Westchester County radiology facility, is no longer undergoing chemotherapy to fight the disease. She is receiving oxygen, morphine and anti-nausea medication.
Ruscitto’s suit is the third filed in U.S. District Court for New Jersey involving cancer that was allegedly spread by a morcellator, and it is one of nearly two dozen around the country. The others – against four device makers, including Karl Storz Endoscopy-America Inc., which is named in Ruscitto’s suit, and Ethicon, a subsidiary of Johnson & Johnson — are being considered by the Judicial Panel on Multidistrict Litigation for consolidation.
Karl Storz Endoscopy did not respond to requests for comment.
Ruscitto’s case is different from the others, her lawyer says, because it includes malpractice claims against the hospital and her doctors, Howard H. Jones, a gynecologic oncologist; Eugenia C. Kuo, a gynecologist; and Celeste A. Telfeyan, an anesthesiologist.
Stratis argues that when Ruscitto had surgery Oct. 17, there had already been so much publicity about the potential dangers of power morcellators that the health care providers should have known, informed her and secured her consent before the surgery.
She “specifically told him [Jones] that she had tremendous anxiety of ovarian cancer,” the lawsuit said.
Maureen Curran Kleinman, a spokeswoman for The Valley Hospital and its related medical group — where Jones and Kuo are employed — said, “We will not be commenting on this matter.”
Bergen Anesthesia Group, which employs Telfeyan, did not respond to requests for comment.
On Friday, Rep. Bill Pascrell Jr., a Paterson Democrat, joined 11 other members of Congress in asking the U.S. comptroller general to investigate how the power morcellator was approved by the federal Food and Drug Administration in the first place, and what’s being done to make sure it is safe enough to remain on the market.
“The power morcellator is only one of many medical devices to raise serious concerns about safety and efficacy,” said Pascrell, who has pushed for improved tracking of devices and reporting of adverse events.
Ruscitto’s lawsuit contends that months before her surgery, the government advised health professionals about the danger of spreading previously undetected cancer when the device was used. Other methods of doing the procedure were available, the lawsuit says, and her doctor should have done a biopsy before opting for morcellation.
An estimated 600,000 hysterectomies are performed a year. The FDA first approved power morcellators in 1991, making it possible for surgeons to do minimally invasive hysterectomies. Traditionally, the procedures were performed via an incision in the abdomen or pubic area. With the device, surgeons promised a faster, easier recovery, with less chance of infection, and considered the risk of spreading cancer to be extremely rare.
Recently the FDA revised its assessment of the cancer risk. It now says that one in every 350 women who undergoes a hysterectomy for fibroids has a cancer that may not have been detected but could be spread by morcellation.
The high-speed, spinning blades of a morcellator cut and shred tissue into smaller fragments that can be removed through small incisions. When it minces the tissue, some fragments may be left behind, attaching to the intestines or the abdominal wall, or even traveling to other areas of the body through blood vessels or lymph. If the tissue contains cancer, the dispersed cells cause the cancer to spread, or metastasize, and change it from an early-stage cancer to a much higher stage. Stage 4 leiomyosarcoma is considered incurable.
“Hundreds, if not thousands, of women in America are dead” because the device was used on them in a laparoscopic hysterectomy, the congressional contingent wrote in Friday’s letter. “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.”
In Ruscitto’s case, she was diagnosed with Stage 4 cancer within weeks of her operation.
The first public attention to potential problems with the device came in December 2013, when a Boston anesthesiologist, Amy Reed, and her husband, a heart surgeon, spoke about her battle with metastatic leiomyosarcoma in The Wall Street Journal. Their story, about her diagnosis following a routine hysterectomy performed with a power morcellator, appeared on the front page. Reed’s husband, Hooman Noorchashm, started an online petition at change.org to stop the use of power morcellators in minimally invasive gynecologic surgery. His one-man campaign reached the FDA and federal lawmakers.
In April 2014 the FDA issued a “safety communication” discouraging use of power morcellators for uterine fibroids and told health care professionals to discuss the risks and benefits of the treatment with their patients. That month, Johnson & Johnson, the device’s largest manufacturer, suspended sales of new morcellators. Many health systems also suspended their use.
An FDA panel held two days of public hearings about morcellators in July 2014.
That same month, Johnson & Johnson asked its customers to return the devices and withdrew from the market. The Journal of the American Medical Association published a study showing that the risk of spreading a hidden uterine cancer was much higher than the 1-in-10,000 previously estimated.
Ruscitto’s surgery took place in October. She returned to work soon after, according to another of her attorneys, Michael Gunzburg.
On Nov. 24, the FDA issued an official warning against the use of power morcellators for “the majority of women.” It told manufacturers to place a black-box warning about the risks of the device on their products. Many insurers subsequently limited their coverage of procedures that use the device.
By that time, Ruscitto had received her diagnosis of leiomyosarcoma and was getting ready for treatment at Memorial Sloan Kettering.
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Routine Procedure At N.J. Hospital Allegedly Spread Cancer in Woman's Body
Aug 13, 2015 | Ridgewood-Glen Rock Patch
By Tom Davis
A woman suffering from an aggressive form of cancer is suing a New Jersey hospital for using a potentially dangerous device that she says spread cancer cells through her body during what was supposed to be a routine hysterectomy.
Viviana Ruscitto, 43, the mother of a toddler, said a power morcellator was used to cut and shred tissue so it could be sucked out through a tiny opening during the minimally invasive operation. During the procedure, it spattered cancer cells through her abdomen, according to The Record of Bergen County.
In a lawsuit filed in federal court in Newark, Ruscitto says a power morcellator should never have been used for her surgery at The Valley Hospital in Ridgewood last fall, noting that the federal government had already discouraged health-care professionals from using them because of the risk of spreading undetected cancer cells, according to the report.
Ruscitto, who has been diagnosed with the rare cancer Stage 4 leiomyosarcoma, has sued the device maker, her doctors and Valley hospital, saying the metastases have spread quickly, obstructing her intestines and causing so much swelling she looks nine months pregnant, The Record said.
None of the defendants have agreed to comment.
The FBI announced recently that it is investigating the device, and the U.S. Food and Drug Administration issued a warning about the cancer risk in April 2014, saying morcellation could “significantly worsen...the patient’s likelihood of long-term survival,” according to CBS News.
A judge in federal district court agreed last week to Ruscitto’s attorney’s request to take her testimony immediately in her room at Memorial Sloan Kettering Cancer Center because she may not live to attend the trial, the attorney, Demetrios Stratis, told The Record.
Ethicon, a division of Johnson & Johnson that made the devices, has advised doctors to stop using them and withdrew them from the market.
Before that, about 60,000 such procedures were performed every year, and at least one of the affected patients has been interviewed by the FBI about her case, according to the report.
Ruscitto’s suit is the third filed in U.S. District Court for New Jersey involving cancer that was allegedly spread by a morcellator, and it is among nearly two dozen around the country. The others are being considered by the Judicial Panel on Multidistrict Litigation for consolidation, according to the Record report.
One such case involved Amy Reed, an anesthesiologist and mother of six, who underwent a hysterectomy with a morcellator at Boston’s Brigham and Women’s Hospital in 2013. Follow-up testing showed she had cancer that had spread through her abdomen, according to CBS.
Her family has gathered more than 88,000 signatures on a Change.org petition asking for a stop to the surgery.
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Congress urges feds to probe FDA over morcellator safety concerns
Aug 10, 2015 | Fierce Medical Devices
By Emily Wasserman
The FDA has faced its fair share of scrutiny over power morcellators, with the public and advocacy groups claiming that the agency took a backseat in regulating the devices. Now Congress is weighing in on the issue, urging the federal government to investigate the FDA's approval process and monitoring of the tools.
As The Wall Street Journal reports, a bipartisan group of 12 lawmakers including Rep. Mike Fitzpatrick (R-PA) and Rep. Louise Slaughter (D-NY) sent a letter to the U.S. Government Accountability Office (GAO) asking the agency to look into the FDA's track record on morcellators. Regulators have cleared at least 10 power morcellator devices for sale since the first one hit the market 24 years ago. And even though the FDA cautioned about morcellators' risk of spreading undetected cancers after the issue surfaced in late 2013, its warning "came decades after some studies were already pointing to a serious problem," the letter states, as quoted by the WSJ.
"(T)he FDA, the medical device industry, and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-10,000," the letter states, as seen by the WSJ. "How did they get it wrong for so long?"
Last year, the FDA issued a warning against using laparoscopic power morcellator tools in minimally invasive surgeries to remove uterine fibroids. The agency said that women undergoing the procedures had a 1 in 350 risk of uterine sarcoma and that morcellator tools could exacerbate the spread of cancerous cells. Before regulators issued their warning, the device was used in about 50,000 U.S. uterine surgeries each year.
The agency's warning triggered public and industry 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 ramped up its oversight of power morcellator products, recommending against using the devices in the "majority" of women undergoing a hysterectomy or uterine fibroid removal. The agency also called for boxed warnings and two contraindications for power morcellators in their product labels.
Still, some argue that the FDA's oversight of power morcellators points to a bigger problem, as the agency's lenient clearance system allows too many risky devices to hit the market. But the FDA is defending the process, saying that 510(k) clearance allows regulators to balance "innovation and safety," Dr. William Maisel, the agency's chief scientist, told the WSJ last year.
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Lawmakers Ask GAO to Investigate Power Morcellators
Aug 11, 2015 | MedScape
By Robert Lowes
Twelve members of Congress asked a federal watchdog agency last week to investigate why the US Food and Drug Administration (FDA) took so long to warn that power morcellators may spread unseen cancers in the course of removing uterine fibroids.
"Hundreds, if not thousands, of women in America are dead" because of these devices, the bipartisan group of lawmakers wrote in an August 7 letter to the US Government Accountability Office (GAO).
The lawmakers also want the GAO to determine whether an expedited FDA process for approving medical devices "sufficiently identified" the cancer risk before power morcellators entered the marketplace.
The 12 members of Congress include Rep. Michael Fitzpatrick (R-PA), Rep. Louise Slaughter (D-NY), and Rep. Ralph Abraham, MD (R-LA).
First approved in 1991, morcellators shred uterine tissue for easy removal through laparoscopic incisions. The FDA recommended in April 2014 that surgeons stop using the devices for hysterectomy or myomectomy in most women with uterine fibroids. It estimated that 1 in 350 women undergoing these procedures for fibroid removal have an unsuspected uterine cancer. Six months later, the agency added a boxed warning to the devices saying that they may spread occult cancer and "decrease the long-term survival of patients."
The healthcare industry has been retreating from the use of power morcellators ever since. One manufacturer, Johnson & Johnson, has voluntarily withdrawn its morcellators from the market, and several major insurers have dropped or restricted coverage of the procedure. As a result, fewer surgeons are morcellating uterine tissue, according to America's Health Insurance Plans.
Courting of Congress Pays Off
The recent scrutiny of power morcellators began in early 2014 after anesthesiologist Amy Reed, MD, PhD, underwent a hysterectomy for fibroid removal in late 2013 and later discovered that the procedure led to the upstaging of an occult tumor. Dr Reed and her husband, cardiothoracic surgeon Hooman Noorchashm, MD, PhD, have vigorously campaigned for the ban of power morcellators and reform of the FDA approval process, called 510(k), that brought the devices to market. Under 510(k), a manufacturer need only establish that its product is substantially the same as a device already approved by the agency. Dr Reed and Dr Noorchashm say this expedited process endangers patients because it lacks premarket safety testing and mandatory postmarket monitoring for adverse events.
The physician couple has courted various members of Congress to join their cause. With the request for a GAO investigation, their efforts have apparently paid off.
The 12 lawmakers who petitioned the GAO noted that studies going back to 1990 have reported that the risk for women having occult uterine cancer was anywhere from 1 in 200 to 1 in 462.
"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-ten thousand," the lawmakers wrote. "How did they get it so wrong for so long?"
Besides requesting a study of the FDA's delayed response to the risk associated with power morcellators and the possible failings of its 510(k) process, the 12 members of Congress asked the GAO to determine the following:
Whether power morcellator manufacturers, importers, user facilities, and the FDA followed adverse-event reporting regulations to safeguard patients;
What activities or training the morcellator manufacturers provided to clinicians, and what medical society standards apply to learning how to use the devices;
What steps the FDA is taking to decide whether power morcellators should remain on the market.
The GAO does not automatically undertake every investigation requested by Congress. "We typically look at such things as whether data needed would be available, whether there are any legal obstacles, whether an Inspector General's Office already has work under way, as well as several other factors," said GAO spokesperson Chuck Young. It usually takes a few weeks for the agency to decide whether to launch a study, according to Young.
In an interview with Medscape Medical News, Dr Noorchashm acknowledged that a GAO inquiry is not guaranteed. "They probably will investigate," he said. "But there's no guarantee that the Congress will act on a GAO investigation."
"A lot of people have died," said Dr Noorchashm. "The legislation [that established the FDA approval process] is broken. We're asking for a root-cause analysis."
His wife, Dr Reed, underwent cytoreduction and hyperthermic intraperitoneal therapy followed by six rounds of systemic chemotherapy after her upstaged uterine cancer was discovered in 2013. Subsequent MRI and CT scans could not find any cancer, and she returned to work. In February, she had a second operation along with radiation therapy after the cancer resurfaced behind her left kidney, impinging on her spine and the second lumbar nerve.
Dr Noorchashm said his wife experienced a second reoccurrence of the cancer in June, this time near her thoracic spine, leading to more radiation therapy.
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FDA's Handling of Morcellators Gets Scrutiny from Congress
Aug 11, 2015 | Qmed
By Nancy Crotti
A dozen members of Congress have asked the federal government to investigate FDA over its regulation of power morcellators.
It turns out that the devices, used for 24 years in the U.S. to slice up tissue during laparoscopic hysterectomies and myomectomies, can also potentially spread cancer in women.
Rep. Mike Fitzpatrick (R-PA), Rep. Louise Slaughter (D-NY), and a bipartisan group of lawmakers sent a letter last week to the U.S. Government Accountability Office, asking the GAO to scrutinize FDA’s past performance onmorcellators.
Congress wants to know why FDA ever approved power morcellators, according to the letter. The writers asked GAO to consider the following:
Did FDA’s reliance on 510(k) approval policies and procedures sufficiently identify risks of adverse events before it allowed the laparoscopic power morcellator to enter the market?
Were the medical device reporting regulations (21 CFR 803) appropriately followed to protect patient safety?
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?
What steps is FDA taking after issuing a warning about the dangers of the devices to determine whether they are safe to remain on the market?
FDA warned last year that the spinning blades of the once-popular devices could spread an undetectable uterine sarcoma in the abdomen and pelvis. The FBI is reportedly investigating what Johnson & Johnson officials knew about the dangers of power morcellators in spreading cancer when they sold the device.
Johnson & Johnson’s Ethicon subsidiary pulled its morcellators from the market last year, including the GynecareMorcellex tissue morcellator, Morcellex Sigma tissue morcellator, and the Gynecare X-tract tissue morcellator.J&J was the largest manufacturer of the device.
FDA has approved at least 10 power morcellators for sale in the past 24 years, according to a report in the Wall Street Journal. The agency did not respond to the newspaper’s request for comment.
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Power Morcellators are Killing Women: DOJ Finally Investigates
Aug 11, 2015 | Ring of Fire
By KJ McElrath
The laproscopic power morcellator is just the latest in a long line of medical devices that have wound up doing far more harm than good – and that were given rapid and ill-advised approval by the US Food and Drug Administration (FDA). That same federal agency finally issued a warning in late November of 2014 – but only after thousands of women died unnecessarily from what was supposed to be a minor procedure. No actual warning has been issued, however, and many morcellators are still in use. Last week, twelve members of Congress from both parties signed a letter to the Government Accountability Office (GAO) demanding an investigation.
Morcellators, which have been in use for almost a quarter of a century, were designed to simplify hysterectomies by tearing uterine tissues into small bits in order to remove them with a laparoscope (this is sometimes known as “keyhole surgery”). It was touted as a minimally invasive procedure that would reduce hysterectomy recovery time from five days to two. In the process, the device shreds up pre-cancerous cells that are hidden within benign fibroid tissues. This can wind up spreading the cells throughout the body.
As evidence of the dangers became increasingly apparent, physicians began speaking out, and the legal industry began filing lawsuits. Johnson & Johnson, a major manufacturer of morcellators, stopped production and began pulling the devices off the market. Hospitals have curtailed the use of morcellators, and the health insurance industry is calling for greater restrictions on their use. The FDA itself estimated that as many as 1 in 350 women may have pre-cancerous cells concealed inside fibroid tissues. However, it was only after members of Congress began applying pressure that the FDA finally issued an “advisory,” calling for a “black box warning.”
Now, after months of unanswered questions, lawmakers are going over the FDA’s head.
A GAO investigation is certain to shed new light on the FDA’s questionable “510(k) Pre-Approval” process, by which many morcellators from various medical device manufacturers have been approved for use on patients. This “streamlined” process was intended to encourage innovation by making it easier and faster for the health care products industry to bring new medications and devices to market. It will also bring scrutiny to FDA claims that the hidden cancer risks were extremely low, in contradiction to studies going back several years indicating serious concerns.
One thing is almost certain: money was a factor – and not only for medical device manufacturers. Gynecologists also claimed the risks were low – possibly because reduction of surgery time and patient recovery periods saves hospitals on expenditures. It’s another aspect of a profit-driven system in which patient well-being takes a back seat to the corporate bottom line.
Although the GAO has received the request, it may take weeks, or even months, before any action is taken. The review process takes into consideration legal issues, the inspector general’s current workload and whether or not additional information may be required. Attorney Brandon Bogle, who is handling morcellator litigation for the Levin Papantonio law firm, says: “it’s absolutely beyond belief that a company would market and continue to recommend the use of a product that is unreasonably upstaging uterine cancer. This is how depraved corporate America has become.”
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Government Accountability Office Asked to Investigate FDA’s Handling of Surgical Tool’s Risks
Aug 12, 2015 | News Inferno
By F.A. Kelley
Twelve members of Congress have asked the Government Accountability Office (GAO) to investigate why a device used in gynecologic surgery was marketed for two decades before safety warnings were issued by the Food and Drug Administration (FDA).
The power morcellator allows fibroid surgeries and hysterectomies to be done through small incisions rather than large abdominal incisions, but the device can also spread and worsen undetected uterine cancer, Philly.com reports.
The morcellator’s rapidly spinning blades cut bulky growths or the uterus itself into pieces that can be removed through tiny incisions. But dangerous cancers that cannot be detected prior to surgery can be spread in the woman’s abdomen and this significantly reduces a woman’s long-term chance of survival, according to the Wall Street Journal.
Dr. Amy Reed, an anesthesiologist, who experienced the spread of such a cancer, and her husband, heart surgeon Hooman Noorchashm, have been campaigning for a ban on the power morcellator. Reed has recently been treated for a second recurrence of uterine leiomyosarcoma, according to Philly.com.
Their couple’s campaign prompted an FDA review of the device. Last year the FDA warned of the power morcellator risk, using a new type of directive called “immediately in effect guidance.” Since the warning, hospitals and insurers have sharply curtailed use of the device and some manufacturers, including Johnson & Johnson’s Ethicon division, have taken the device off the market. The FDA said morcellators should be avoided in women who are at or near menopause or in patients whose tissue can be removed intact through the vagina or via a small abdominal incision. Morcellators should never be used, the FDA said, when the tissue is known or suspected to be cancerous.
The FDA estimates that up to one in 350 women undergoing hysterectomy might have a hidden cancer that could be spread by the morcellator. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said there is “no reliable way” to determine if a uterine fibroid is cancerous prior to removal. When the device came on the market in 1993, the risk was estimated to be one in 10,000, Philly.com reports. In their August 7 letter to the GAO, the members of Congress asked, “How did they get it so wrong for so long?” “We respectfully request that you investigate the root cause failure that ultimately led to the FDA’s black box warning on . . . morcellators in November 2014.”
Rep. Mike Fitzpatrick of Pennsylvania, lead signer of the letter, has joined Reed and Noorchashm in pushing for broad changes in the medical-device approval process. Rep. Louise Slaughter of New York and Rosa DeLauro of Connecticut are also among the letter’s signers. GAO spokesman Chuck Young said the GAO would decide whether to investigate based on factors including the availability of data, potential legal obstacles, and investigations that may be underway, Philly.com reports.
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