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Morcellation Media Monitoring 06/1/2015
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Extended KYW Clip
May 30, 2015 | KYW (Philadelphia, PA)
By Stephanie Stahl
Click here to view clip: http://beta.criticalmention.com/app/#clip/view?14032142/token/3a36203e-fa50-4819-8c9e-783b64b04c0d This longer version of KYW's interview with Dr. Amy Reed and Dr. Hooman Noorchashm, that originally aired on May 27, also ran on four CBS affiliates. Transcript: Is the FDA doing enough to protect patients from potentially dangerous medical devices? Two Philadelphia area doctors say no, as a mother fights for her life. -
WBTV Clip
May 30, 2015 | WBTV (Charlotte, NC)
Click here to view clip: http://beta.criticalmention.com/app/#clip/view?14032215/token/3a36203e-fa50-4819-8c9e-783b64b04c0d Transcript: We first told you about Dr. Amy Reed who has cancer last year. Now the mother of six and her husband's efforts have reportedly helped spark an FBI probe in what Johnson & Johnson knew about the medical device and when it learned it might spread cancer in some women. -
Doctor with cancer raises alarm about medical device
May 29, 2015 | CBS News Online
Is the FDA doing enough to protect patients from potentially dangerous medical devices? Two Philadelphia area doctors say no. They're fighting to prevent more tragedies, while living through their own medical nightmare. -
FBI investigating if hysterectomy danger was properly reported, doctor says
May 29, 2015 | NJ.com
By Kathleen O'Brien
The Federal Bureau of Investigation is looking into whether the medical community neglected to report potentially fatal side-effects of a hysterectomy surgical tool, according to a doctor who says he has been interviewed by the agency. -
5 things to know about FBI investigation into Johnson & Johnson cancer device
May 29, 2015 | Atlanta Journal Constitution
One doctor said she tested negative for cancer before a hysterectomy, but months later doctors found a rare form... The FBI is now investigating what Johnson & Johnson -- the largest manufacturer of the device -- knew before it yanked the tool off the market last year. -
FBI starts Investigating Medical Device linked to Uterine Cancer
Jun 1, 2015 | West Texas News
By Leah Gardiner
According to reports of Wall Street Journal, the Federal Bureau of Investigation (FBI) has begun investigating a surgical gynecological tool after receiving complaints that the tool spreads uterine cancer in women during a procedure. -
The Investigation into whether Johnson & Johnson Knew about their Harmful Uterine Device
May 29, 2015 | Science Times
By Rachel K Wentz
Johnson & Johns is under investigation by the FBI for possible prior knowledge about dangers linked to one of their medical devices, the laparoscopic power morcellator, which is supposed to provide a minimally invasive alternative to hysterectomies and removal of fibroid tumors, but in reality, may have been spreading dangerous forms of cancers among its patients. -
FBI Probes Who Knew What and When in Power Morcellation Imbroglio
May 29, 2015 | Cancer Letter
By Matthew Bin Han Ong
The Federal Bureau of Investigation 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. -
J&J Under FBI Scrutiny Following Reports That Uterine Device Could Spread Cancer
May 29, 2015 | Tech Times
By Jan Dizon
The Federal Bureau of Investigation (FBI) is investigating the Johnson and Johnson (J&J) company over their possible knowledge that their uterine surgery device, the laparoscopic power morcellator, used in procedures for hysterectomies and removing fibroids in minimally invasive surgeries with faster recovery times, may have been spreading rare and malignant cancers in patients. -
FBI Investigating Johnson & Johnson For Cancer-Spreading Surgical Device
May 29, 2015 | Headline & Global News
By Julie Sabino
The FBI is conducting an investigation to determine the extent of Johnson & Johnson’s knowledge of a surgical device’s hazards prior to announcing its recall last year. -
FBI Enters Uterine Morcellator Debacle
May 29, 2015 | NEJM Journal Watch
By Amy Orciari Herman
The FBI is inLL3pC.dpufvestigating uterine power morcellators, including whether their largest manufacturer — Johnson & Johnson — knew almost a decade ago that they might cause undiagnosed cancer to spread, the Wall Street Journal reports. -
FBI Investigating Morcellators
May 30, 2015 | Medical Device and Diagnostic Industry
By Marie Thibault
Laparoscopic power morcellators continue to be in the spotlight—and that scrutinizing light may be getting harsher. The Wall Street Journal reported this week that the FBI is examining morcellators, which have been known to spread or upstage gynecological cancers in women. -
DCGI urged to ban Power Morcellator used in hysterectomy as it causes cancer
Jun 1, 2015 | Pharmabiz.com (India)
By Peethaambaran Kunnathoor
In a letter sent to Dr G N Singh, the drugs controller general of India, the professor of pharmacy at the Birla Institute of Technology in Ranchi and former chairman of the Hospital Pharmacists Association, Dr Roop Narayan Gupta, wanted him to ban the medical device, Power Morcellator, used in hysterectomy or uterus removal as studies show that its use leads to dissemination of malignant tissue.
Morcellation
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May 30, 2015 | KYW (Philadelphia, PA)
By Stephanie Stahl
This clip also ran on:
WOWK (CBS) Charleston, WV
KFVS (CBS) Paducah, KY
KFDA (CBS) Amarillo, TX
WBTW (CBS) Myrtle Beach, SC
Transcript: Is the FDA doing enough to protect patients from potentially dangerous medical devices? Two Philadelphia area doctors say no, as a mother fights for her life. They're fighting to prevent more tragedies, while living through their own. Stephanie Stahl reports from Philadelphia. Amy Reed is on a mission, trying to save other families, from the agony hers is enduring. The 42-year-old has six children and a deadly cancer. She says her prognosis is not good. Amy and her husband Hooman Norchashm are both doctors who feel patients' lives are in to Amy, as a patient, will happen to others. Dr. Noorchashm says, "I'm worried every day, it's like having a gun to your head." Back in 2013 Amy had what was supposed to be a routine operation. a device called a morcellator was used to shred fibroid tumors, so they could be easily remed. Doctors didn't know before the operation that the fibroids were cancerous. The shredding ended up inadvertently spreading the cancer. Dr. Reed says, "This type of cancer it's like ink, once you spill it you can't just go back and undo it.. I had no idea that they used this type of technique." Just recently Aetna the country's third largest insurer said it's ending coverage for most procedures using morcellators, and many surgeons have stopped using the device. a year ago, when morcellators were first investigated, Amy had been through multiple surgeries and rounds of radiation and chemotherapy. She recently had a recurrence, a tumor in her spine. When asked what she tells her children, Amy said, "Having kid forces you to be very forthcoming. You say cancer and they say well will it kill you and you say i don't know." While hoping t find a way to keep Amy alive, the Bucks County doctors and others want the FDA to devices are safe. The FDA says, "The vast majority of devices perform well .. in some cases identified.. when this occurs the FDA carefully assesses the issue and takes action to protect the public health based on scientific data." For now, Amy and her husband are spending as much time as they can with their children, the youngest is only two. That was Stephanie Stahl reporting.
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May 30, 2015 | WBTV (Charlotte, NC)
Transcript: We first told you about Dr. Amy Reed who has cancer last year. Now the mother of six and her husband's efforts have reportedly helped spark an FBI probe in what Johnson & Johnson knew about the medical device and when it learned it might spread cancer in some women. >> This type of cancer I said it is like ink, once you spil it, you can't undo it. >> A doctor used the device on on Reed to shred fibroids. Johnson & Johnson stopped selling them last July. They did not return our message seeking comment and the national office of the FBI didn't, either, but according to the Wall Street Journal, agents have been calling patient and pathologists asking about the morcellators. >> We known for awhile the morcellators do have risk. >> Dr. Peter Weiss, an attending OB/GYN at Providence Hospital in Santa Monica used the morcellator only sparringly, because he is always cautious about new technology. >> Anything that comes out new and sounds wonderful and is exciting, you have to have a little reservation, until you have a little time lag, so you can see what are the risks, what are the benefits. >> Aetna won't cover most procedures involving the morcellator, and many surgeons will not use it. Reed no doubt wishes her doctors had been more skeptical, she says her prognosis, isn't good.
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Doctor with cancer raises alarm about medical device
May 29, 2015 | CBS News Online
Is the FDA doing enough to protect patients from potentially dangerous medical devices? Two Philadelphia area doctors say no. They're fighting to prevent more tragedies, while living through their own medical nightmare.
42-year-old Dr. Amy Reed and her husband, Dr. Hooman Noorchashm, have been fighting their battle since Reed was diagnosed with cancer in 2013. CBS Philly's Stephanie Stahl has been following their story for a year.
Reed's cancer was found after an operation to remove uterine fibroid tumors. Surgeons used adevice called a power morcellator to shred the fibroid tissue so it could be easily removed through a small incision. But the shredding ended up inadvertently spreading cancer that hadn't been detected.
One of the device makers, Johnson & Johnson, pulled its morcellators off the market last year after the FDA issued a safety communication warning doctors about the risk. The FDA did not order a recall, saying the device could be appropriate for a small number of women.
Reed and Noorchashm say more should have been done to protect patients, and they have spoken with FBI investigators about their concerns.
"This is a violation of federal law that has led to the loss of life, so I think that is what got the FBI's attention," Noorchashm told CBS Philly.
Earlier this week, the Wall Street Journal reported that the FBI is looking into what Johnson & Johnson knew about the device's risks. Problems were reportedly first brought to the company's attention in 2006.
Reed says if action had been taken earlier, her situation might have been prevented -- "not only mine but hundreds of other women. That's what's so maddening."
Since her diagnosis, Reed has been through multiple surgeries and rounds of radiation and chemotherapy. She recently had a recurrence, a tumor in her spine.
When asked what she tells her six children, she replied, "Having kids forces you to be very forthcoming. You say 'cancer' and they say 'well, will it kill you?' And you say 'I don't know.'"
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FBI investigating if hysterectomy danger was properly reported, doctor says
May 29, 2015 | NJ.com
By Kathleen O'Brien
The Federal Bureau of Investigation is looking into whether the medical community neglected to report potentially fatal side-effects of a hysterectomy surgical tool, according to a doctor who says he has been interviewed by the agency.
Hooman Noorchashm, a thoracic surgeon who has crusaded relentlessly against the device since its use in his wife's routine hysterectomy spread her cancer, said he has been interviewed several times by agents out of the FBI's Newark office.
The main manufacturer of the surgical power tool, called a morcellator, is Ethicon, the Somerville-based division of Johnson & Johnson.
A spokesman for the company said it had not been contacted by the FBI.
The device is a power shaver on the end of a thin tube that is inserted through a tiny incision into the uterus to mince and suction out tissue. This form of laparoscopic surgery has been popular with women because of the reduced scarring and recovery time compared to a conventional hysterectomy.
The problem – which turned out to be much more common than previously realized – was that undetectable cancer cells could be splattered throughout the abdominal cavity by the device. What at the onset of surgery was a Stage 1 cancer became a Stage 4 cancer at its conclusion.
The U.S. Food and Drug Administration last year issued a warning against use the device for most hysterectomies, saying the risks were simply too high.
In response, Johnson & Johnson suspended sales of its morcellator.
"In July 2014, we voluntarily withdrew all of the Ethicon devices, and Ethicon morcellation devices remain off the market. We are the only manufacturer of these devices to have taken such action," the company said in a statement.
Noorchashm said he reached out to the FBI last fall, urging the agency to look into whether doctors, hospitals and manufacturers had failed to report any fatal surgical outcomes to the FDA, as the agency's regulations require.
"If someone violates the law and people die because of it, is that a crime? You tell me," he said. He and his wife, who continues to battle Stage 4 leiomyosarcoma, moved from Boston back to Philadelphia last year to be near family. He is now affiliated with Thomas Jefferson University Hospital.
The FBI's press office in Newark said it was the agency's policy to neither confirm nor deny the existence of any investigation.
Noorchashm said the FBI had also interviewed a retired Pennsylvania pathologist who has said he became concerned about an unusual number of "upstaged" cancers. The man has said publicly that he contacted Ethicon as early as 2006 with his concerns.
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5 things to know about FBI investigation into Johnson & Johnson cancer device
May 29, 2015 | Atlanta Journal Constitution
One doctor said she tested negative for cancer before a hysterectomy, but months later doctors found a rare form.
“No point in time did anyone ever say, ‘Well you know because you had it morcellated, that worsens your prognosis.’ That's something we discovered on our own,” patient Dr. Amy Reed said.
The FBI is now investigating what Johnson & Johnson -- the largest manufacturer of the device -- knew before it yanked the tool off the market last year.
The FBI investigation comes after the FDA warned doctors should not use the device on most women.
Many hospitals across the country said they have stopped or cut back on using it.
Here are five things to know about Morecellators:
1. What is it?
It’s a medical device used in the treatment of women diagnosed with symptomatic fibroids. While fibroids are benign growths, they can cause symptoms that include heavy uterine bleeding, pelvic pain and infertility in many women. In these cases, fibroids may be treated with a surgical procedure called myomectomy, which removes the fibroid masses from the uterus, or hysterectomy, a procedure that removes the entire uterus.
2. How many are performed?
About 60,000 of these procedures are performed every year, estimated Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health.
3. When did doctors start using them?
The FDA approved the first power morcellator for use in 1995, Maisel said. A non-power version of the morcellator received FDA approval in 1991.
4. When did they recognize the risks?
The medical community has been aware of the risk of cancer spread during power morcellation since the device came onto the market, but "the magnitude of the risk appears to be higher than what was appreciated in the clinical community," Maisel said.
5. How many cases?
The FDA estimates that about one in 350 women undergoing a hysterectomy or fibroid removal has an unsuspected type of cancer called uterine sarcoma.
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FBI starts Investigating Medical Device linked to Uterine Cancer
Jun 1, 2015 | West Texas News
By Leah Gardiner
According to reports of Wall Street Journal, the Federal Bureau of Investigation (FBI) has begun investigating a surgical gynecological tool after receiving complaints that the tool spreads uterine cancer in women during a procedure.
According to the investigation by FBI, the pharmaceutical company Johnson & Johnson, the largest manufacturer of the power morcellator, was familiar about the risk of the device and didn't warn customers and physicians. As per the reports, the device was pulled off in 2014, but some other morcellator manufacturers continued selling the device.
A spokeswoman from the FBI, New Jersey office, did not disclose anything about the investigation. On the other side, a spokesperson for Johnson & Johnson's Ethicon division said that the company has not been contacted by FBI regarding the device.
The Wall Street Journal contacted the three individuals who were questioned by the FBI office in Newark about the morcellator device. An anesthesiologist, Dr. Amy Reed, has been among the people contacted by the FBI. Reed underwent a hysterectomy for fibroid removal about two years ago just to find out that the morcellator had made her cancer worse. Currently, Reed and her husband have been protesting to ban the device to save women's lives.
Sarah Robinson, a physician assistant in Los Altos, was also contacted by the FBI about two months ago. While talking to the Wall Street Journal, Robinson said she was testified at a Food and Drug Administration hearing on the device. According to Robinson, she also created a list of ladies families who were supporting the ban of morcellator device. She sent a list of about 386 people to FBI.
The investigation by FBI followed a warning that was issued by FDA in November 2014. The warning said, "The device shouldn't be used on the vast majority of women. One in 350 who underwent the procedure had an unsuspected cancer sarcoma." The agency also called for a 'black-box' warning on the tool.
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The Investigation into whether Johnson & Johnson Knew about their Harmful Uterine Device
May 29, 2015 | Science Times
By Rachel K Wentz
Johnson & Johns is under investigation by the FBI for possible prior knowledge about dangers linked to one of their medical devices, the laparoscopic power morcellator, which is supposed to provide a minimally invasive alternative to hysterectomies and removal of fibroid tumors, but in reality, may have been spreading dangerous forms of cancers among its patients.
The tool in questions contains small spinning blades that cut tissue into small pieces so that the tissue can be removed via suction through small incisions on the patient's abdomen. This laparoscopic technique provides a simpler means of performing surgeries, such as hysterectomies, which traditionally required lengthy recovery times due to the opening of the belly.
The problem with the morcellator, however, is that those same little blades that dice up normal tissue and fibroids can spread malignant cells if undetected cancers are present. The investigation centers on how long Johnson & Johnson has known about the potential dangers.
With the investigation ongoing, details from the FBI have been scarce, but it appears complaints from medical personnel about the potential dangers of the morcellator have been ongoing for years. By law, manufacturers, doctors, and hospitals are required to notify the FDA of any potential harmful effects of medical products. Physicians involved in the investigation claim they notified Johnson & Johnson as far back as 2006 about the dangers of using the morcellator on women at high risk for cancer.
The FDA released communications concerning the device in April of 2014, laying out potential dangers.
At the time of the report, the FDA stated that approximately 1 in 350 women undergoing hysterectomy or myomectomy (fibroid removal) for the treatment of fibroids is found to have an unsuspected uterine sarcoma. They warn that there is no reliable method for predicting or testing whether a woman with fibroids may have uterine sarcoma.
They gave a stark warning that using a power morcellator in women with unsuspected uterine sarcoma risks spreading the cancerous tissue within the abdomen and pelvis, which significantly worsens a patient's long-term survival.
They also provided guidelines for contraindications, such as women who are peri- or post-menopausal or candidates for en bloc tissue removal, which make up the majority of patients undergoing hysterectomy or myomectomy.
Johnson & Johnson removed morcellators from the market in July of 2014. As the investigation plays out, their culpability concerning prior knowledge about the dangers of their product should come to light.
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FBI Probes Who Knew What and When in Power Morcellation Imbroglio
May 29, 2015 | Cancer Letter
By Matthew Bin Han Ong
The Federal Bureau of Investigation 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.
According to the Wall Street Journal, the FBI’s Newark, N.J. office interviewed three people, including Robert Lamparter, a retired pathologist who alerted Ethicon, a J&J subsidiary, about potential problems with morcellators in 2006.
A full account of Lamparter’s 2006 complaint can be found at the Pittsburgh Business Times, which reported on the whistleblower case in May 2014.
FBI agents also interviewed Amy Reed, the doctor who led the campaign against power morcellation, as well as Sarah Robinson, a physician assistant in Los Altos, Calif., who told the WSJ she sent an FBI agent a list of 386 names of patients and their families who may have been harmed by the device.
It’s not publicly known whether a formal investigation has been launched. The FBI declined to comment, in response to a previous inquiry from The Cancer Letter, on the “existence or nonexistence” of an investigation (The Cancer Letter, April 10).
J&J officials told the WSJ that they were not aware of an FBI investigation. The company pulled its power morcellators from the market in July 2014, after the FDA issued a warning, and after an FDA advisory panel expressed low confidence in power morcellation as a treatment for uterine fibroids (The Cancer Letter, Aug. 1, 2014).
The FBI may be looking into whether J&J had violated federal law by neglecting to report adverse events, Hooman Noorchashm, Reed's husband, said previously to this reporter (The Cancer Letter, April 10). Noorchashm is a cardiac surgeon at the Thomas Jefferson University Hospital.
Reed and Noorchashm’s interview with The Cancer Letter appeared on the ABC News coverage of the FBI investigation May 27.
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J&J Under FBI Scrutiny Following Reports That Uterine Device Could Spread Cancer
May 29, 2015 | Tech Times
By Jan Dizon
The Federal Bureau of Investigation (FBI) is investigating the Johnson and Johnson (J&J) company over their possible knowledge that their uterine surgery device, the laparoscopic power morcellator, used in procedures for hysterectomies and removing fibroids in minimally invasive surgeries with faster recovery times, may have been spreading rare and malignant cancers in patients.
Although the reports do not indicate how far the FBI is into the investigation, as early as last year, J&J already started pulling the devices off the market and requesting doctors who were using it to return the devices.
According to a report by the Wall Street Journal, three people have already been interviewed in relation to the investigation, but J&J has yet to be contacted and have also denied any knowledge of the investigation.
Allegations against J&J infer that the company knew of the risks associated with its laparoscopic tool already back in 2006. The power morcellator apparently had a high chance of spreading uterine cancer in patients who underwent surgery using the device.
The tool grinds fibroid tissues in the uterus and removes them via a vacuum and a small opening. The same tool is also used for hysterectomy procedures, removing the tissue in the same tube which require less recovery times than traditional procedures.
However, cancerous fibroid tissues left undetected also spread during the procedure can result in more aggressive and even fatal from of sarcoma.
According to Sean Tracey, a personal injury and product defect attorney from the law firm Tracey & Fox, the news of the investigation against J&J is welcome and has been a long time coming.
"If the FBI's investigation concludes that J&J knew about these serious risks posed by its own product, and chose to ignore those risks from 2006 until April 2014, it will be crushing to those families to know that their situation could have been avoided. They deserve justice," he said.
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FBI Investigating Johnson & Johnson For Cancer-Spreading Surgical Device
May 29, 2015 | Headline & Global News
By Julie Sabino
The FBI is conducting an investigation to determine the extent of Johnson & Johnson’s knowledge of a surgical device’s hazards prior to announcing its recall last year.
The U.S. Federal Bureau of Investigation (FBI) is reportedly investigating a Johnson & Johnson surgical device that has been linked to the spreading of cancer in women.
The American health care giant announced a recall of uterine surgery tools last year following reports that the tools could cause cancer. The Ethicon unit of the company reached out to hospitals asking them to return a line of devices used in hysterectomies and uterine surgeries. The action followed the U.S. Food and Drug Administration (FDA) advisory in April 2014 that discouraged doctors from using morcellators, as it poses a risk in spreading cancerous tissues. Morcellators are commonly used in laparoscopic operations for fibroid removal in the uterus, a procedure that calls for the extraction of the entire uterus.
During that time, speculations rose that Johnson & Johnson promptly announced the recall to avoid lawsuits and bad public relations. The company denied the allegation.
Sources told The Wall Street Journal on Thursday that the FBI is conducting an investigation to determine the extent of Johnson & Johnson's knowledge of the surgical device's hazards prior to announcing the recall. People familiar with the investigation said that the FBI has interviewed at least three people in the past few months to get information.
One of the people interviewed, Robert Lamparter, a former pathologist at Evangelical Community Hospital in Lewisburg, Pa., said that he talked to the FBI on May 12 about how he alerted the company about the potential risks of the surgical device in 2006. The Wall Street Journal was able to obtain copies of the emails and letters related to the issue.
Johnson & Johnson spokesman Matthew Johnson confirmed the alert and clarified that the company did not ignore the warning. They used the information to revise the instructions of using the device.
The FBI's Newark, N.J., office, which oversees the investigation, and Johnson & Johnson both declined to comment on the report.
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FBI Enters Uterine Morcellator Debacle
May 29, 2015 | NEJM Journal Watch
By Amy Orciari Herman
The FBI is investigating uterine power morcellators, including whether their largest manufacturer — Johnson & Johnson — knew almost a decade ago that they might cause undiagnosed cancer to spread, the Wall Street Journal reports.
The devices, used laparoscopically to cut fibroids into small pieces for removal, can cause undetected uterine cancer to disperse throughout the abdomen and pelvis. In 2014, the FDA found that roughly 1 in 350 women undergoing hysterectomy or myomectomy for fibroids has undiagnosed uterine sarcoma. Johnson & Johnson pulled its morcellators from the market in July.
Now, the Wall Street Journal reports that the FBI has recently interviewed three people connected to the devices: a pathologist who warned Johnson & Johnson about the potential for cancer spread in 2006, a woman whose cancer became worse after undergoing the procedure in 2013, and a physician assistant who has compiled a list of hundreds of people potentially harmed by the devices.
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FBI Investigating Morcellators
May 30, 2015 | Medical Device and Diagnostic Industry
By Marie Thibault
Laparoscopic power morcellators continue to be in the spotlight—and that scrutinizing light may be getting harsher. The Wall Street Journal reported this week that the FBI is examining morcellators, which have been known to spread or upstage gynecological cancers in women.
The device is used to chop up uterine tissue, facilitating removal a patient's uterus through a minimally invasive laparoscopic hysterectomy. Patient advocates say that these small pieces of tissue can be spewed around, and if they contain undetected malignant tissue, can upstage and spread cancer. There has been debate over how commonly this happens, with some disputing FDA's finding that 1 in 350 women undergoing hysterectomies or myomectomies for fibroids has an undetected uterine sarcoma. Some surgeons continued to use morcellators after the issue came to light because they think the benefits of a minimally invasive procedure outweigh the risks. The controversy has been covered heavily by the media since late 2013.
In 2014, FDA published safety communications about power morcellation and maker Johnson & Johnson issued a voluntary recall of its power morcellators. Several health insurers, including Highmark and United Healthcare, have said they will not cover use of morcellators during hysterectomies. A number of health systems and hospitals have stopped performing hysterectomies with morcellation.
According to WSJ, in addition to asking questions about morcellators, the FBI is also reportedly trying to learn what knowledge Johnson & Johnson, a major maker of the devices before a voluntary recall last summer, had about the risks of the device. The WSJ article noted that the FBI's Newark, NJ office declined comment and the a Johnson & Johnson spokesperson said the company did not know about the agency's review.
WSJ's knowledge of the investigation seems to have come from interviews with doctors and patients close to the morcellator debate who say they have been asked by the FBI for details about the issue.
One person who has been contacted by the FBI, according to WSJ, is Dr. Amy Reed. Reed and her husband, Dr. Hooman Noorchashm, have actively advocated for banning power morcellators since Reed had a hysterectomy with the device in late 2013 and soon after, was diagnosed with advanced stage uterine sarcoma. The couple is now also advocating for reform of CDRH and recently penned a column for MD+DI on the topic.
Sarah Salem-Robinson is another patient that has been contacted by FBI, according to WSJ. Salem-Robinson filed a citizen petition with FDA earlier this year asking the agency to ban the devices.
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DCGI urged to ban Power Morcellator used in hysterectomy as it causes cancer
Jun 1, 2015 | Pharmabiz.com (India)
By Peethaambaran Kunnathoor
In a letter sent to Dr G N Singh, the drugs controller general of India, the professor of pharmacy at the Birla Institute of Technology in Ranchi and former chairman of the Hospital Pharmacists Association, Dr Roop Narayan Gupta, wanted him to ban the medical device, Power Morcellator, used in hysterectomy or uterus removal as studies show that its use leads to dissemination of malignant tissue.
Dr Gupta’s letter mentions that there is crystal clear evidence in research studies which reveal that this surgery tool can spread hidden uterus cancer. Considering the study report, the use of the device should be banned in India or restricted with immediate effect.
According to him, the Federal Agency in the US is investigating the case of spread of cancer by the use of this device. A list of 386 cancer related cases has been submitted alone in the US. In India, he argues that, there is no reporting system on such happening. Though the manufacturer of the device (J&J) has withdrawn this tool from the market in July last year, same type of device from other morcellator manufacturers is on sale in the market today.
“The Food and Drugs Control Administration (FDA) in US restricted its use and warned about cancer risk. In the wake of it, several hospitals there have curtailed its use. But in India, the device is used in surgery in several cases. Therefore, the DCGI has been urged to consider a ban on the use of this device in our country”, he said.
A study report reveals that Power Morcellators, the drill-like surgical tools, used to shred and remove tissue in surgeries such as hysterectomies, fibroid removal and other gynecological operations, faced scrutiny in 2013 when several women in US suffered uterine cancer after routine surgeries performed with the devices.
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