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Morcellation Media Monitoring 05/28/2015

Television Segments Aired Since AM Report

MSNBC Clip
May 28, 2015 | MSNBC
By Tamron Hall

Click here to view clip: http://beta.criticalmention.com/app/#clip/view?14015908/token/c0a24e0b-e25b-4b5a-b6ba-14631da923bc Transcript: Now to a major investigation into a medical device known to spread cancer in women
KCTV5 News Clip
May 28, 2015 | KCTV5 (Kansas City, MO)
By Bonyen Lee

Click here to watch video: http://beta.criticalmention.com/app/#clip/view?14015754/token/c0a24e0b-e25b-4b5a-b6ba-14631da923bc Transcript: The FBI is now investigating makers of the morcellator
KYW Clip
May 28, 2015 | KYW (Philadelphia, PA)
By Stephanie Stahl

Click here to view clip: http://beta.criticalmention.com/app/#clip/view?14015813/token/c0a24e0b-e25b-4b5a-b6ba-14631da923bc Transcript: The FBI is reportedly investigating about who knew what and when about a surgical tool suspected of spreading undetected cancer in women.
WBZ News Clip
| WBZ (Boston, MA)
By Mallika Marshall

Click here to view clip: http://beta.criticalmention.com/app/#clip/view?14015832/token/c0a24e0b-e25b-4b5a-b6ba-14631da923bc Transcript: Tonight the FBI is investigating Johnson & Johnson and a device that was used to treat thousands of woman for a common problem.
ABC News Clip
May 28, 2015 | ABC News
By Marci Gonzalez

The following clip ran 36 local ABC affiliates since the last report, all of which are listed in the Full Text section of the report. Click here to view clip: http://beta.criticalmention.com/app/#clip/view?14012731/token/c0a24e0b-e25b-4b5a-b6ba-14631da923bc Transcript: A medical tool that is supposed to help women in need might be responsible for making the situation much worse.

Print/Online Articles Published Since Midday Report

Johnson & Johnson in FBI's crosshairs over power morcellator
May 28, 2015 | Seeking Alpha
By Douglas W. House

The FBI is investigating what Johnson & Johnson (NYSE:JNJ) knew about the hazards of its laparoscopic power morcellator before it pulled it off the market in July of last year.
FBI Investigating Johnson & Johnson Hysterectomy Device
May 28, 2015 | CBS Boston
By Mallika Marshall

WBZ-TV first introduced you to the Needham mom who developed metastatic cancer after undergoing a morcellation procedure to treat her uterine fibroids.

Television Segments Included in Previous Report

ABC News Clip
May 28, 2015 | ABC News Clip
By Marci Gonzales

Click here to view clip: http://beta.criticalmention.com/app/#clip/view?14012731/token/c0a24e0b-e25b-4b5a-b6ba-14631da923bc Transcript: A medical tool that is supposed to help women in need might be responsible for making the situation much worse.
ABC World News Morcellator Clip
May 27, 2015 | ABC World News
By Mara Schiavocampo

Click here to view clip: http://beta.criticalmention.com/app/#clip/view?14004946/token/56ce7c31-2da5-4b4d-9cbb-61b832448200 Transcript: Tonight, to a major headline now involving women and their health. The FBI is investigating a widely used surgical device suspected of spreading cancer in some women. It's main manufacturer, Johnson & Johnson, eventually pulling it off the market. But tonight, the FBI now asking, who knew what and when?
Good Morning America Clip
May 28, 2015 | ABC
By Mara Schiavocampo

Click here to view clip: http://beta.criticalmention.com/app/#clip/view?14006788/token/c0a24e0b-e25b-4b5a-b6ba-14631da923bc Transcript: A health alert for millions of women treated for a device that authorities say may be responsible for spreading a cancer. The FBI is investigating this device made by Johnson & Johnson and other companies.
News 12 Long Island Clip
May 28, 2015 | News 12 News (Long Island, NY)

Click here to view clip: http://beta.criticalmention.com/app/#clip/view?14006791/token/c0a24e0b-e25b-4b5a-b6ba-14631da923bc Transcript: The FBI reportedly investigating what Johnson & Johnson knew about a surgical device that may actually spread cancer in women.
KOMU 8 News Today Clip
| KOMU 8 News Today (Columbia, MO)

Click here to view clip: http://beta.criticalmention.com/app/#clip/view?14006799/token/c0a24e0b-e25b-4b5a-b6ba-14631da923bc Transcript: Johnson & Johnson is being investigated by the FBI for a surgical device found to spread cancer in women.

Print/Online Articles Included in Previous Report

F.B.I. Investigates Whether Harm From Surgical Power Tool Was Ignored
May 28, 2015 | New York Times
By Denise Grady and Katie Thomas

The Federal Bureau of Investigation has begun looking into whether medical device makers, doctors and hospitals broke the law by failing to report problems linked to a power tool used during gynecologic surgery, according to two people who said they were interviewed by investigators.
FBI Is Investigating Hysterectomy Device Found to Spread Uterine Cancer
May 27, 2015 | Wall Street Journal
By Jennifer Levitz

The FBI is investigating a surgical device that was found to spread cancer in women, including looking into what the largest manufacturer of it, Johnson & Johnson, knew about the tool’s hazards before pulling it off the market last year, according to three people who have been interviewed.
Pharmalot.. Pharmalittle.. Good Morning: We’re Catching up on J&J, AbbVie, Teva and Lots More!!
May 28, 2015 | Wall Street Journal Pharmalot Blog
By Ed Silverman

The FBI is investigating a surgical device that was found to spread cancer in women, including what Johnson & Johnson JNJ +0.31% knew about its hazards before pulling it off the market last year, according to The Wall Street Journal. Over the past several months, FBI agents interviewed a retired pathologist who alerted J&J about potential problems with morcellators in 2006, a doctor who went public after her own cancer was worsened by the tool in 2013, and a California woman who has collected nams of close to 400 patients and relatives who may have been harmed by the tool.
FBI probing what J&J knew about uterine surgery device - WSJ
May 27, 2015 | Reuters
By Ankur Banerjee

The Federal Bureau of Investigation is probing a surgical tool found to spread uterine cancer and what Johnson & Johnson knew about its risks before withdrawing its version of the device last year, the Wall Street Journal reported.
WSJ: FBI investigating J&J morcellator suspected of spreading cancer
May 28, 2015 | Al Jazeera America

The Federal Bureau of Investigation is probing a surgical tool found to spread uterine cancer and what Johnson & Johnson knew about its risks before withdrawing its version of the device last year, the Wall Street Journal reported.
Report: FBI investigating medical device that spread cancer in women
May 27, 2015 | CBS News Online

The FBI reportedly is investigating a medical device that was withdrawn from the market last year after it was found to spread cancer in women. The Wall Street Journal reports investigators are looking into what Johnson & Johnson, the largest manufacturer of the device, knew about the problems.
FBI Investigating Medical Device That Spread Cancer in Some Women
May 28, 2015 | ABC Radio Online

The FBI is investigating whether Johnson and Johnson was aware that a surgical device it manufactured could spread cancer in the women on whom it is used.
Medical device complaint reportedly draws FBI attention
May 28, 2015 | Philadelphia Inquirer
By Marie McCullough

After a surgical device spread an aggressive but undetected uterine cancer inside anesthesiologist Amy Reed in late 2013, she and her husband launched a campaign to ban electric morcellators.
FBI investigating Johnson & Johnson over hysterectomy device pulled from market: report
May 27, 2015 | NY Daily News
By Deborah Hastings

The FBI is questioning makers of a surgical device that can spread cancer cells in female patients, asking Johnson & Johnson officials what the manufacturing giant knew about the tool before yanking it out of service in 2014, according to a new report.
Widowers welcome morcellation investigation
May 28, 2015 | Rochester Democrat & Chronicle
By Patti Singer

Husbands of two Rochester-area women who died after a procedure worsened their undetected uterine cancers welcomed news of a federal investigation into what manufacturers knew about hazards of the device called a power morcellator.
FBI Investigates J&J’s medical device believed to have spread cancer in women
May 28, 2015 | Maine News Online
By Tanya Campbell

The FBI is investigating Johnson and Johnson's surgical device that breaks down growths in the uterus so that they can be easily removed.
FBI investigating J&J for its surgical tool that spreads cancer in women
May 27, 2015 | MedCity News
By Meghana Keshavan

More bad news for the laparoscopic power morcellator. The FBI is now investigating a surgical device that’s been found to spread cancer cells in women, the Wall Street Journal reports.
FBI said to probe devices known to spread cancer in women
May 27, 2015 | Modern Healthcare
By Steven Ross Johnson

Federal investigators are reportedly conducting a probe of medical devices that have been linked to spreading cancer in women.
WSJ: J&J target of FBI probe over power morcellator devices
May 27, 2015 | FierceMedicalDevices
By Emily Wasserman

Johnson & Johnson ($JNJ) is facing more pushback over power morcellator devices used in minimally invasive gynecological procedures, as the FBI investigates how much the company knew about the products' risks before pulling them from the market last year.
Health Highlights: May 28, 2015
May 28, 2015 | HealthDay

Cancer-Spreading Hysterectomy Device Focus of FBI Investigation A hysterectomy device found to spread uterine cancer is the focus of an FBI investigation.
FBI Probing Power Morcellators, WSJ Reports
May 28, 2015 | MedScape Medical News
By Robert Lowes

The FBI is investigating power morcellators, the surgical tool in widespread disfavor because it can spread occult uterine cancers during gynecologic procedures, the Wall Street Journal (WSJ) reported today.
FBI reportedly investigating J&J medical device
May 28, 2015 | Healthcare Packaging
By Michelle Maskaly

The FBI is reportedly investigating a Johnson & Johnson-made hysterectomy device that can spread cancer in female patients, according to multiple news reports.
Johnson & Johnson Laparoscopic Power Morcellator Lawsuits Filed Over Cancer Spread In Women
May 28, 2015 | Inquistr

Lawsuits over a Johnson & Johnson laparoscopic power morcellator has the FBI investigating the surgical device found to be responsibility for spreading cancer in women. It’s also suspected that Johnson & Johnson knew about the device’s hazards prior to yanking it off the market in 2014, according to The Wall Street Journal.
FBI investigating surgical tool suspected of 'spreading cancer in women'
May 28, 2015 | Daily Mail Online (UK)
By Julian Robinson

The FBI is investigating a surgical tool found to spread uterine cancer in women, it has been reported. Pharmaceutical giant Johnson & Johnson said in July last year that it would ask doctors to return the device, which is used to treat growths called fibroids.

Television Segments Aired Since AM Report

MSNBC Clip

May 28, 2015 | MSNBC

By Tamron Hall

Transcript: Now to a major investigation into a medical device known to spread cancer in women. The Wall Street Journal reports the FBI is investigating the device for hysterectomies. The FDA warned it could be dangerous and spread undetected cancer to other parts of the body. Johnson & Johnson pulled it from the market last July, acknowledging the risk. The FBI wants to know how long the company knew about the problem. The Journal reports one scientist says he warned the company about the risks in 2006. Johnson & Johnson tells MSNBC the FBI has not contacted the company. Joining me now is Dr. Amy Reed who underwent the procedure and had cancer spread throughout her abdomen. Thank you for your time. >> Thank you for having me. >> Let me ask you about your health, how are you now? >> I'm doing well today, thank you. Take it day by day.>> Like so many other women, taking it day by day. I have to tell you, when I saw this headline and read the article in the Wall Street Journal, I could not believe what I was reading. This is part of the investigation. Talk me through what happened to you and why you believe it's linked to this medical device. >> Sure. Certainly. So, I underwent a hysterectomy in 2013 for what I was told was a normal fibroid. I was having issues, went to my gynecologist, had a work up, MRI, biopsies, and said this is normal. This is what happens with fibroids. If you want to get over this, you need to have surgery. so, I went and talked to the surgeon. They said we will do this laparoscophy. You will be home in no time and feel fantastic. I underwent the surgery in 2013. Eight days later, I got a phone call. You have cancer. You have sarcoma. I said what does that mean? The gynecologist said I'm not sure. You'll have to talk to an oncologist who specializes in cancer. She says you will likely need another surgery, I'm not sure beyond that. >> You have been interviewed now several times by the FBI over the past few months. Johnson & Johnson released a statement, April 2014, following the health notification, we opted to suspend this device. They go on to say in July, 2014, they voluntarily withdrew all the devices. The FBI does not comment on their investigations. Here you are, a mother, an anesthesiologist and went through a process to save your life, keep you there for your children and you were put at risk. >> Exactly. So, I finished my earlier statement exactly where most people would have been left off with the diagnosis you have cancer. However, my husband and I are both physicians. My husband is a surgeon. We pressed more. We said how was the operation done? Did you get it out in one piece with wide margins, which is considered the only treatment of this cancer? That's when we learned that these tools called morcellators exist and they are used to shred tissue to suck them out of small incisions. We knew almost immediately, if you do this to sarcoma, you have created a very big problem. It is a very aggressive cancer. When you spread it in that fashion, it can grow. When we went in and did further literature searches, the gynecologists published data showing somewhere around 1-300 women have this sarcoma. If you use a morcellator on it, the chance of recurrence is 80%. If it comes back, the medium life expectancy is two years. >> 1 in 350 women according to the FDA stat. I want your reaction from the group who does not want this machine banned. It says converting all hysterectomies to open surgery would result in an annual increase of 17 more women dying of surgery each year and increase in morbidity from open surgery, so they do not want it banned. They believe that there is more good than harm that comes from this procedure. >> So, I think you summarized it really well saying there's more good than harm. That's exactly the argument that they are trying to foster, the notion that it does, most people do find some set of women, myself included. We are not an insignificant subset, do not do fine. This is not good medical practice. Other branches of surgery do not use this tool. It's sloppy medicine. We could go into the root cause of why we think it's the case. Doctors are supposed to treat each and every patient and they have a duty to that one patient to do what's best. You can't use it. It benefits the majority in medicine. That's the oath that we take. In terms of, you know, leading to more death and adverse outcomes, they have asked this question, since they have taken the majority of them off shelves and out of the hands of physicians, has there been an up tick in mortality? The resounding answer has been no. So, you know, while that may have been a theoretical question, I don't think there's any evidence to support that at this case. I think there's this tool, is bad medicine. Therefore, they should stop using it all together. >> We will continue to follow this investigation and the developments there. Thank you for joining us. We greatly appreciate it. Thank you

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KCTV5 News Clip

May 28, 2015 | KCTV5 (Kansas City, MO)

By Bonyen Lee

Transcript: Nearly a month after we told you about an OB/GYN tool causing concerns for women, the FBI is now investigating makers of the morcellator. And a quick warning -- you might find some of the images graphic.KCTV5's Bonyen Lee has the update. 5:05 PM((20:17:30)) "We knew because of our traing was just dead wrong like they should not be doing is practice at all." Anesthesiologist Amy reed went from treating patients to becoming one - after she says her doctor used a morcellator to perform her hysterectomy. A device which uses a blade to shred growths, Reed believes spreads the cancerous growths it's designed to remove. ((Hooman Noorchashm)) "The FDA is essentially approving devices for marketing which have not undergone stringent enough safety testing." Reed and her husband Hooman Noorchashm were some of the firsts to blow the whistle on the device that is now at the center of an FBI investigation. According to the Wall Street Journal - investigators want to know if companies like Johnson & Johnson knew about the dangers before it pulled the device last year. ((Kimberly Swan, gynecologic surgeon Univ. of Kansas)) "The national organizations do continue to support morcellation with appropriately selected patients because they do recognize there is a benefit for our patients." Dr. Kimber Swan at the University of Kansas hospital now uses a bag to contain tissue matter when morcellating fibroids - she says her standard of care will continue to remain the same. "The FBI investigation doesn't have any impact on the current FDA recommendations for morcellation of patients." Bonyen Lee, KCTV5 news. One of the largest makers - Johnson & Johnson - stopped producing the device last year. The company says the FBI had not contacted it for information regarding the investigation.

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KYW Clip

May 28, 2015 | KYW (Philadelphia, PA)

By Stephanie Stahl

Transcript: The FBI is reportedly investigating about who knew what and when about a surgical tool suspected of spreading undetected cancer in women. Authorities are looking into whether medical device makers, doctors, hospitals broke the law by failing to report problems link to that device. Morcellators are used in procedures, they have been linked to several deaths and injuries. Morcellators work by a shredding fibroid that are to be removed but in some patient that is shredding inadvertently spread cancer that had not been detected. Our Stephanie Stahl talked to Amy Reid, who has six children and a deadly cancer that she and her husband says was caused by morcellators. They should never have been used. >> Uour situation might have been prevented. >> Yes, not only mine but hundreds of other women and that is what is so maddening. ... The FBI won't confirm or deny an investigation.

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WBZ News Clip

| WBZ (Boston, MA)

By Mallika Marshall

Transcript: Tonight the FBI is investigating Johnson & Johnson and a device that was used to treat thousands of woman for a common problem. They pulled the device of some patients were diagnosed with cancer, and others died, but the question is did they know the device could spread cancer? >> I had fibroids becoming increasingly problematic after my last pregnancy. >> A year and a half ago, Dr. Amy Reed, an anesthesiologist and mother of six, had a hysterectomy for uterine fibroids at a local hospital. They used a device called a power morcellator which grinds the uterus into pieces so it can be removed through a small hole. Little did Amy or her doctors know, she had cancer hidden in her uterus which was literally spread throughout her belly with the morcellation procedure, turning likely localized disease into stage four metastatic cancer. “They spread cancer all around,” says Amy. “This type of cancer I say is like ink. Once you spill it, you can’t just go back and undo it.” Amy and her husband, Dr. Hooman Norchasm, have been fighting since her diagnosis to get morcellation banned. “The morcellator was in the marketplace for 20 years,” Hooman says. “And it was hurting people at a rate of 1 in 300 or 1 in 350, whatever that magic number is, and no one knew about it. “The FDA didn’t know about it. And these folks would just go home and die,” he adds. Last year the FDA issued strong warnings on the product label and a division of Johnson & Johnson, the largest manufacturer of the device, advised doctors to stop using it and pulled it from the market. Now, theWall Street Journal is reporting that the FBI will investigate what Johnson & Johnson knew about the risks all along. Amy is now 42 years old, and her cancer recently returned. She’s had more surgery and radiation but she and Hooman concerned about the future. “Am I worried? Yes. Daily,” he said. “It’s like having a gun to your head, but I also think that we will beat this thing.”“I think having kids forces you to be very forthcoming and very honest,” says Amy. “They say, ‘What is it?’ ‘Cancer.’ ‘Will it kill you?’ And you say ‘I don’t know, which is the truth.’One of their concerns is that medical devices don’t undergo the same scrutiny as medications in this country, and that the doctors using them don’t always know what the risks are. Though Johnson & Johnson pulled their morcellation device off the market, there are other companies that still make them.

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ABC News Clip

May 28, 2015 | ABC News

By Marci Gonzalez

This clip ran on the following ABC affiliates:
WTEN (ABC) - Albany, NY
WVEC (ABC) - Norfolk, VA
WNC8 (NEWS8) - Washington, DC
KESQ (ABC) - Palm Springs, CA
KEZI (ABC) - Eugene, OR
KOLO (ABC) - Reno, NV
KNTV (NBC) - San Francisco, CA
KABC (ABC) - Los Angeles, CA
KVIA (ABC) - El Paso, TX
KEYT (ABC) - Santa Barbara, CA
KERO (ABC) - Bakersfield, CA
WBRZ (ABC) - Baton Rouge, LA
KHGI (ABC) - Lincoln, NE
WHTM (ABC) - Harrisburg, PA
WKRN (ABC) - Nashville, TN
WZZM (ABC) - Grand Rapids, MI
KSTP (ABC) - Minneapolis-St. Paul, MN
WCJB (ABC) - Gainesville, FL
WGGB (ABC) - Springfield, MA
WJBF (ABC) - Augusta, GA
WMAR (ABC) - Baltimore, MD
WCPO (ABC) - Cincinnati, OH
KSWO (ABC) - Wichita Falls, TX
WJET (ABC) - Erie, PA
WEHT (ABC) - Evansville, IN
WTNH (ABC) - Hartford & New Haven, CT
WFAA (ABC) - Dallas, TX
WTVC (ABC) - Chattanooga, TN
WEWS (ABC) - Cleveland, OH
KAKE (ABC) - Wichita, KS
WHSV (ABC) - Harrisonburg, VA
KSFY (ABC) - Sioux Falls, SD
KCRG (ABC) - Cedar Rapids, IA
WSIL (ABC) - Paducah, KY
KLTV (ABC) - Tyler, TX
Transcript: A medical tool that is supposed to help women in need might be responsible for making the situation much worse. Marci Gonzales has the details on this. a surgical device- once used on tens of thousands of women every year- now suspected of spreading cancer in some cases. The FBI now looking into - "the laparoscopic power morcellator" it's used to treat fibroids or benign uterine tumors which affectup to half of women under 50 - by breaking the fibroids into pieces so they can be more easily removed. But in as many as one in 350 cases cancer is hidden in that fibroid and can be inadvertently spread by the device. The FDA does not have any idea how many people were harmed by this device. But the idea that it happened to anyone is concerning. "We don't know how many people this has happened tobut it is a risk etc" doctor amy reed says - it happened to her the anesthesiologist says she was checked for cancer before a hysterectomy last fallthe results came back negative but then after the morcellation - doctors did find- a rare form of cancer. "At 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." Johnson & Johnson - was the top manufacturer of the device- the FBI now looking into - what they knew - and when the mecal supply powerhouse was first alerted to the possible risk. In 2006 by a pathologist and didn't pull the device off the market until July of last year, doing so voluntarily "due to the continued uncertainty" adding "to date we are the only manufacturer to proactively take this action." The FBI's investigation comes after the FDA warned in November that morcellators should not be used on most women. Many hospitals across the country have reportedly stopped or cut back on their use of the device.

Return to headline | Return to top

Print/Online Articles Published Since Midday Report

Johnson & Johnson in FBI's crosshairs over power morcellator

May 28, 2015 | Seeking Alpha

By Douglas W. House

The FBI is investigating what Johnson & Johnson (NYSE:JNJ) knew about the hazards of its laparoscopic power morcellator before it pulled it off the market in July of last year. The FDA warned the medical community last November that the device, which was used to cut up uterine fibroids for removal through tiny incisions in the abdomen, could increase a woman's risk of cancer. According to the agency, women undergoing fibroid surgery have a one in 350 chance of harboring uterine sarcoma. The cutting action of the morcellator blades could contribute to the spread of the cancer cells to other parts of the body.

The FBI has interviewed a retired pathologist who alerted the company in a letter about the potential risk in 2006 and a California woman who has collected ~400 names of patients and families who may have been harmed by the device.

Company spokesman Matthew Johnson confirmed the pathologist's 2006 letter and added that the firm revised its operating instructions as a result, adding to language already present which cautioned about the potential spread of suspected malignant tissue.

The FBI also interviewed a Pennsylvania anesthesiologist who underwent the procedure in 2013 at a Boston hospital. The hospital acknowledged that it worsened her cancer in addition to another patient the year before.

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FBI Investigating Johnson & Johnson Hysterectomy Device

May 28, 2015 | CBS Boston

By Mallika Marshall

WBZ-TV first introduced you to the Needham mom who developed metastatic cancer after undergoing a morcellation procedure to treat her uterine fibroids.

Due in large part to her and her husband’s campaign to stop the practice, a company that manufactured the device is now being investigated by the Feds.

A year and a half ago, Dr. Amy Reed, an anesthesiologist and mother of six, had a hysterectomy for uterine fibroids at a local hospital. They used a device called a power morcellator which grinds the uterus into pieces so it can be removed through a small hole.

Little did Amy or her doctors know, she had cancer hidden in her uterus which was literally spread throughout her belly with the morcellation procedure, turning likely localized disease into stage four metastatic cancer.

“They spread cancer all around,” says Amy. “This type of cancer I say is like ink. Once you spill it, you can’t just go back and undo it.”

Amy and her husband, Dr. Hooman Norchasm, have been fighting since her diagnosis to get morcellation banned.

“The morcellator was in the marketplace for 20 years,” Hooman says. “And it was hurting people at a rate of 1 in 300 or 1 in 350, whatever that magic number is, and no one knew about it.

“The FDA didn’t know about it. And these folks would just go home and die,” he adds.

Last year the FDA issued strong warnings on the product label and a division of Johnson & Johnson, the largest manufacturer of the device, advised doctors to stop using it and pulled it from the market. Now, theWall Street Journal is reporting that the FBI will investigate what Johnson & Johnson knew about the risks all along.

Amy is now 42 years old, and her cancer recently returned. She’s had more surgery and radiation but she and Hooman concerned about the future.

“Am I worried? Yes. Daily,” he said. “It’s like having a gun to your head, but I also think that we will beat this thing.”

“I think having kids forces you to be very forthcoming and very honest,” says Amy. “They say, ‘What is it?’ ‘Cancer.’ ‘Will it kill you?’ And you say ‘I don’t know, which is the truth.’

One of their concerns is that medical devices don’t undergo the same scrutiny as medications in this country, and that the doctors using them don’t always know what the risks are. Though Johnson & Johnson pulled their morcellation device off the market, there are other companies that still make them.

Return to headline | Return to top

Television Segments Included in Previous Report

ABC News Clip

May 28, 2015 | ABC News Clip

By Marci Gonzales

The clip ran on the following local ABC affiliates:
WTEN (ABC) - Albany, NY
KLKN (ABC) - Lincoln, NE
WHAS (ABC) - Louisville, KY
WTVM (ABC) - Columbus, GA
WJET (ABC) - Erie, PA
WCPO (ABC) - Cincinnati, OH
WKBW (ABC) - Buffalo, NY
WHAM (ABC) - Rochester, NY
WLOX (ABC) - Biloxi, MS
WCJB (ABC) - Gainesville, FL
WGNO (ABC) - New Orleans, LA
WSYR (ABC) - Syracuse, NY

Transcript: A medical tool that is supposed to help women in need might be responsible for making the situation much worse. Marci Gonzales has the details on this. a surgical device- once used on tens of thousands of women every year- now suspected of spreading cancer in some cases. The FBI now looking into - "the laparoscopic power morcellator" it's used to treat fibroids or benign uterine tumors which affectup to half of women under 50 - by breaking the fibroids into pieces so they can be more easily removed. But in as many as one in 350 cases cancer is hidden in that fibroid and can be inadvertently spread by the device. The FDA does not have any idea how many people were harmed by this device. But the idea that it happened to anyone is concerning. "We don't know how many people this has happened tobut it is a risk etc" doctor amy reed says - it happened to her the anesthesiologist says she was checked for cancer before a hysterectomy last fallthe results came back negative but then after the morcellation - doctors did find- a rare form of cancer. "At 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." Johnson & Johnson - was the top manufacturer of the device- the FBI now looking into - what they knew - and when the mecal supply powerhouse was first alerted to the possible risk. In 2006 by a pathologist and didn't pull the device off the market until July of last year, doing so voluntarily "due to the continued uncertainty" adding "to date we are the only manufacturer to proactively take this action." The FBI's investigation comes after the FDA warned in November that morcellators should not be used on most women. Many hospitals across the country have reportedly stopped or cut back on their use of the device.

Return to headline | Return to top
ABC World News Morcellator Clip

May 27, 2015 | ABC World News

By Mara Schiavocampo

The clip ran on the following ABC affiliates:
WZZM (ABC) - Grand Rapids, MI
WTEN (ABC) - Albany, NY
WCTI (ABC) - Greenville, NC

Transcript: Tonight, to a major headline now involving women and their health. The FBI is investigating a widely used surgical device suspected of spreading cancer in some women. It's main manufacturer, Johnson & Johnson, eventually pulling it off the market. But tonight, the FBI now asking, who knew what and when? Here's ABC's Mara Schiavocampo. >> Reporter: Tonight, a medical device that can put women at greater risk of deadly uterine cancer is the subject of an FBI investigation, including what the largest maker of the device, Johnson & Johnson, knew about the risks and when they knew it. Johnson & Johnson first was alerted to the possible risks in 2006 by a pathologist. Soon others in the medical community started sounding the alarm, and Johnson & Johnson removed it from the market last July. The FDA implementing its most serious warning on the device last November. The surgical device, the power morcellator, breaks down growths in the uterus so they can easily be removed. But in up to one in 350 cases, an unknown cancer is hidden in that fibroid. And in these cases, the morcellator can spray those cancer cells within the uterus spreading and potentially worsening the disease. Which is what dr. Amy Reed and her husband say happened in her case. >> if you disrupt the mass, it's like a bee's hive. If you start chopping it up, the bees spill all over the place and you're in trouble. >> Reporter: We reached out to Johnson & Johnson, who told us they have not been contacted by the FBI, adding, so far, they are the only manufacturer to have pulled the device. Others do remain on the market with that FDA blackbox warning. David?

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Good Morning America Clip

May 28, 2015 | ABC

By Mara Schiavocampo

Transcript: A health alert for millions of women treated for a device that authorities say may be responsible for spreading a cancer. The FBI is investigating this device made by Johnson & Johnson and other companies. Mara Schiavocampo has the latest. >> Reporter: The device is called the power morcellator. It's used to treat fibroids or benign uterine cancers. It breaks the fibroids into pieces to more easily be removed. But in 1 of 350 cases, cancer is hidden in those fibroids. In those cases, the tool can spread it. >> At no point in time, did anyone ever say, well, because you had it morcellated, that worsens your prognosis. we discovered that on our own. >> Reporter: Dr. Amy Reed and her husband said she was checked for cancer before a hysterectomy, the results, negative. But after the morcellation done, doctors found she had a rare form of cancer. Johnson & Johnson was first alerted in 2006 by a pathologist and voluntarily pulled the device last July due to the continued uncertainty. Adding “To date, we're the only manufacturer to proactively take this action.” >> They were contacted seven years ago. Why didn't this happen then? Why didn't they speak up then? >> Reporter: In November, the FDA issued a black box warning, its strongest caution, on the device.

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News 12 Long Island Clip

May 28, 2015 | News 12 News (Long Island, NY)

Transcript: The FBI reportedly investigating what Johnson & Johnson knew about a surgical device that may actually spread cancer in women. That's acording to the Wall Street journal. Johnson & Johnson is the largest manufacturer of the tool known as a morcellator. It's used perform hysterectomies. It was pulled from the market last year after the government issued a warning about the device possibly spreading cancerous cells. Johnson and Johnson hasn't commented.

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KOMU 8 News Today Clip

| KOMU 8 News Today (Columbia, MO)

Transcript: Johnson & Johnson is being investigated by the FBI for a surgical device found to spread cancer in women. So far, agents have interviewed a retired pathologist who reportedly alerted the company to problems with a morcellator in 2006. A morcellator is a tool commonly used in performing hysterectomies.

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Print/Online Articles Included in Previous Report

F.B.I. Investigates Whether Harm From Surgical Power Tool Was Ignored

May 28, 2015 | New York Times

By Denise Grady and Katie Thomas

The Federal Bureau of Investigation has begun looking into whether medical device makers, doctors and hospitals broke the law by failing to report problems linked to a power tool used during gynecologic surgery, according to two people who said they were interviewed by investigators.

The tool, called a morcellator, has rapidly spinning blades that cut tissue into pieces that can be removed from the body through the tiny slits made during minimally invasive surgery. Morcellators have often been used in surgery to remove the uterus, but in some women with undetected cancers they have sprayed malignant cells around inside the abdomen like seeds, speeding the progression of the disease.

The inquiries were first reported on Wednesday by The Wall Street Journal, which said the agents worked out of the F.B.I. office in Newark, N.J.

Celeste Danzi, a spokeswoman for the F.B.I.’s Newark office, declined to confirm the inquiry. “We just don’t comment on the existence or nonexistence of any investigation,” she said.

In an interview with The New York Times, Dr. Hooman Noorchashm, whose wife, Dr. Amy Reed, was harmed by the device, confirmed that they had spoken a number of times to an F.B.I. agent from Newark. A retired pathologist from Pennsylvania, Dr. Robert W. Lamparter, also said he had spoken to investigators. Both men declined to name the agent, saying they had been warned that disclosing too much information could interfere with the investigation.

Dr. Reed, 42, an anesthesiologist, had a hysterectomy because of fibroid tumors in her uterus in October 2013 at Brigham and Women’s Hospital in Boston. Fibroids are benign, but they sometimes hide cancer. A biopsyafter Dr. Reed’s surgery found a hidden sarcoma, an aggressive type of cancer. The tumor spread, resulting in advanced Stage 4 cancer. Dr. Reed underwent numerous rounds of chemotherapy and radical surgery, but the cancer recurred in March of this year, near her spine, requiring still more surgery.

The couple, who have six children, have conducted a ceaseless nationwide campaign to ban morcellation. Gynecology groups have resisted, saying that sarcomas are uncommon and that morcellation makes surgery less invasive and safer for the majority of women.

In November, the Food and Drug Administration said that morcellators should no longer be used in “the vast majority” of women. But the agency did not take the devices off the market or ban their use.

Dr. Noorchashm said he contacted an agent from the Newark F.B.I. office last fall, because he suspected that morcellator manufacturers and some doctors and hospitals using the devices had violated a federal law requiring that adverse events be reported to the F.D.A. He said that he and his wife spoke with the agent a number of times over a few months, and that the F.B.I. seemed increasingly interested.

Dr. Lamparter said that he had also recently spoken to the F.B.I., and that the conversation had focused on his 2006 correspondence with Ethicon, the unit of Johnson & Johnson that sold power morcellators. At that time, he warned Ethicon of the potential for the morcellators to spread undetected cancer, according to email correspondence he provided to The Times and other news outlets. Johnson & Johnson withdrew its morcellators from the market last July.
Johnson & Johnson has said that after Dr. Lamparter raised his concerns, it added new language to the instructions for use of the device, and that the company had already recommended that, in patients where a cancer was suspected, doctors should use a special bag to remove the tissue.

In a telephone interview Wednesday, Dr. Lamparter said that he considered the change a “legal fig leaf” and that the gynecologists at his hospital, Evangelical Community Hospital in Lewisburg, Penn., reported that the training they received from the company in using the device did not substantially change after he raised his alarm.

Dr. Lamparter said he initially believed that the morcellator could still be used, but not on women at high risk for cancer. However, he added, “I’ve come to believe that the morcellator, as it is used now, is just a bad idea.”

Ernie Knewitz, a Johnson & Johnson spokesman, said it was unaware of any investigation.

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FBI Is Investigating Hysterectomy Device Found to Spread Uterine Cancer

May 27, 2015 | Wall Street Journal

By Jennifer Levitz

The FBI is investigating a surgical device that was found to spread cancer in women, including looking into what the largest manufacturer of it, Johnson & Johnson, knew about the tool’s hazards before pulling it off the market last year, according to three people who have been interviewed.

It is unclear what stage the inquiry is in. The Federal Bureau of Investigation’s Newark, N.J., office, which is overseeing the investigation according to the three people interviewed, declined to comment. A J&J spokesman said the New Jersey-based medical company isn’t aware of an investigation into the device, called a laparoscopic power morcellator.

Over the past several months, FBI agents have interviewed a retired pathologist who alerted J&J about potential problems with morcellators in 2006, a doctor who went public after her own cancer was worsened by the tool in 2013, and a California woman who has collected names of close to 400 patients and families of patients who may have been harmed by the tool, these people said.

The probe comes after the U.S. Food and Drug Administration warned in November that morcellators shouldn’t be used on the vast majority of women.

Many hospitals and the nation’s largest health plans either have curtailed use of morcellators or are considering limits.

Previously used in tens of thousands of minimally invasive procedures a year, power morcellators cut up benign uterine growths known as fibroids so the tissue can be removed through tiny incisions. The device is mostly used in hysterectomies.

The FDA warned in April 2014 that women undergoing fibroid surgery have a 1 in 350 chance of harboring dangerous uterine sarcoma that can’t be reliably detected before the operation. Morcellators can spread the malignancy and worsen the outcome, the FDA said. In November, the FDA called for a “black-box” warning—its strongest caution—on the tool.

J&J withdrew the tools from the market last July. Devices from other morcellator manufacturers remain on sale.

Robert Lamparter, a former pathologist at Evangelical Community Hospital in Lewisburg, Pa., said the FBI interviewed him on May 12 about his 2006 correspondence with the J&J subsidiary that sold morcellators.

Dr. Lamparter contacted the company’s Ethicon division after he began noticing more morcellated specimens in his lab, according to emails and letters reviewed by The Wall Street Journal. He wrote that he was concerned about several issues, including the potential for an undetected cancer to be inadvertently spread by the surgical instrument.

Dr. Lamparter wrote in a February 2006 email to David Robinson, then an Ethicon medical director, that at his small hospital, gynecologists were surprised by an unexpected malignancy at least once a year, for a “1/150 to 1/300 chance that a uterus will have an unexpected malignancy.”

“If a morcellation is done, the patient’s survival is jeopardized,” Dr. Lamparter wrote. He didn’t identify a specific case of this happening.

J&J spokesman Matthew Johnson confirmed the 2006 correspondence with Dr. Lamparter on Tuesday and said the doctor’s concerns led the company to revise the instructions for use of the device.

The new language included a line saying that if cancer is present, use of the morcellator “may lead to dissemination of malignant tissue,” Dr. Robinson wrote Dr. Lamparter in April 2006.

The company’s instructions had already recommended that doctors who suspected or know of malignant tissue should use a “tissue extraction bag”—a bag used to pull tissue from the body—with the device.

Dr. Robinson, who is retired from Ethicon, couldn’t be reached for comment.

Ethicon morcellators “have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue,” Mr. Johnson said in a statement to the Journal.

Mr. Johnson said the company is “continually assessing the totality of the available data and information—including peer-reviewed studies and scientific literature, as well as physician feedback—related to our products.”

Other people said their conversations with the FBI didn’t center on J&J or other manufacturers.

Amy Reed, a 42-year-old Pennsylvania anesthesiologist who has been vocal about her worsened cancer after she underwent a hysterectomy with a morcellator at a Boston hospital in 2013, said the FBI has interviewed her several times over the past few months about her case.

The hospital where she had the procedure has acknowledged it worsened Dr. Reed’s cancer and that the device had spread malignancy in another patient in 2012.

Sarah Robinson, a physician assistant in Los Altos, Calif., said she was contacted by the FBI about two months ago. Ms. Robinson, who testified at an FDA hearing on the morcellator, has collected a list of women and families of women who believe their cancer was worsened by the device. Ms. Robinson said she sent an FBI agent a list of 386 names, which includes herself, on April 3.

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Pharmalot.. Pharmalittle.. Good Morning: We’re Catching up on J&J, AbbVie, Teva and Lots More!!

May 28, 2015 | Wall Street Journal Pharmalot Blog

By Ed Silverman

Good morning, everyone, and how are you today? The sun is trying to peek through a muggy haze descending this morning on the Pharmalot campus, where our officials mascots are lounging about and assorted birds and bugs can be heard in the distance. As for us, we are immersed in our usual routine of foraging for interesting items and brewing cups of stimulation. It is, after all, another busy day. No doubt, it is the same for you. So here are some tidbits to help you along. Hope today proves successful and keep in touch…

The FBI is investigating a surgical device that was found to spread cancer in women, including what Johnson & Johnson JNJ +0.31% knew about its hazards before pulling it off the market last year, according to The Wall Street Journal. Over the past several months, FBI agents interviewed a retired pathologist who alerted J&J about potential problems with morcellators in 2006, a doctor who went public after her own cancer was worsened by the tool in 2013, and a California woman who has collected nams of close to 400 patients and relatives who may have been harmed by the tool.

People with HIV should be put on antiretroviral drugs as soon as they learn they are infected, federal health officials said in announcing they were halting the largest ever clinical trial of early treatment because its benefits were already so clear, The New York Times tells us. The study was stopped more than a year early because preliminary data already showed that those who got treatment immediately were 53% less likely to die during the trial or develop AIDS or a serious illness than those who waited.

A St. Louis jury awarded a Minnesota girl $23 million in punitive damages after deciding that Abbott Laboratories ABT +0.84%’ anti-epileptic drug Depakote was to blame for her birth defects, The St. Louis Post-Dispatch writes. The verdict follows the same jury’s decision to award the 12-year-old plaintiff, Maddison Schmidt, $15 million in compensatory damages. In total, the jury awarded $38 million to Schmidt, after finding that her birth defects, including spina bifida, were the result of her mother taking Depakote while pregnant. AbbVie ABBV +1.90%, however, is financially responsible.

New data to be released this weekend should help deepen the understanding of how broadly new drugs that unleash the body’s immune system to fight cancer can be used, Reuters reports. Results from key clinical trials will be presented at the annual meeting of the American Society of Clinical Oncology and will include studies aimed at defining ahead of time which patients are likely to benefit. At the forefront will be rival drugs from Bristol-Myers Squibb BMY +1.33% and Merck designed to block a protein known as PD-1 that tumors use to evade the body’s immune system.

Teva Pharmaceutical is close to a settlement valued around $1 billion to resolve government allegations its Cephalon subsidiary paid generic drug makers to delay competing versions of the sleep-disorder drug Provigil, according to The Wall Street Journal. The settlement with the U.S. Federal Trade Commission, which could be announced soon, comes ahead of trial proceedings scheduled to begin June 1 in a Philadelphia federal court. The agreement will be a milestone in the FTC’s long-running campaign to stop pay-to-delay settlements.

A lawyer seeking to free two chimpanzees from a state university told a judge Wednesday that their confinement for research purposes is akin to slavery, the involuntary detention of mentally ill people and imprisonment, the Associated Presssays. Steven Wise, an attorney with the Nonhuman Rights Project, argued Hercules and Leo are “autonomous and self-determining beings” who should be granted a writ of habeas corpus and be moved from Stony Brook University on Long Island to a sanctuary in Florida.
Teva Pharmaceutical TEVA +1.25% bought 1.35% of Mylan Laboratories MYL +2.07% stock on the open market, putting pressure on its rival to accept a takeover offer, Bloomberg News reports.

The FDA approved new irritable bowel syndrome drugs from Actavis and Valeant Pharmaceuticals VRX.T +1.59%, validating big investments both companies made to acquire the products, according to Reuters.

Rep. Billy Long (R-Mo.) introduced a bill that would require the FDA to update social media regulations and let drug makers add prescribing information via hyperlinks,Medical Marketing Media says.

Gilead Sciences GILD +2.39% plans to invest another $100 million to add a manufacturing facility to its campus in Edmonton, where about 300 people are employed, The Edmonton Journal writes.

Retrophin agRTRX +11.83%reed to sell a rare pediatric priority review voucher meant to speed drug approval to Sanofi SAN.FR +2.76% for $245 million in cash, just three months after acquiring the voucher as part of a deal to buy Asklepion Pharmaceuticals, says Xconomy.

GlobeImmune GBIM -51.33% and Gilead Sciences suffered a setback after their new hepatitis B vaccine missed its mid-stage trial target, according to Pharma Times.

GlaxoSmithKline GSK.LN +1.73% and the plaintiffs firm leading dozens of thalidomide-injury suits against the drug maker are squabbling over an attorney-client privilege issue before a federal appeals court, The Legal Intelligencer reports.

Novartis NOVN.VX +1.66% is eliminating up to 100 positions from various locations around the U.S. through a voluntary retirement program, a spokeswoman confirms.

Zogenix saZGNX +5.76%ys that fenfluramine, which was once used to fight obesity before it was taken off the market, may help treat a rare disease that causes severe seizures in young children, Reuters reports.

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FBI probing what J&J knew about uterine surgery device - WSJ

May 27, 2015 | Reuters

By Ankur Banerjee

The Federal Bureau of Investigation is probing a surgical tool found to spread uterine cancer and what Johnson & Johnson knew about its risks before withdrawing its version of the device last year, the Wall Street Journal reported.

J&J said in July that it would ask doctors to return the device, called laparoscopic power morcellator, which is used to treat uterine growths called fibroids.

It is unclear what stage the inquiry is in, the Journal reported, citing three people who have been interviewed. (on.wsj.com/1ExNqbU)

A J&J spokesman said the company has not been contacted by the FBI regarding its Ethicon morcellation devices.

The U.S. Food and Drug Administration tightened its guidelines on the use of a uterine surgical technique in November, saying it has been linked to the spread of a rare type of cancer.

This came after the agency issued an alert in April last year discouraging the use of the devices to remove fibroids.

The devices are used to slice fibroid and uterine tissue into small pieces inside the body, allowing it to be removed through a small opening. The procedure is designed to shorten recovery time and reduce wound-site infections.

Yet the technique can cause injury to local tissues and organs and spread unsuspected malignant tissue to places outside the uterus.

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WSJ: FBI investigating J&J morcellator suspected of spreading cancer

May 28, 2015 | Al Jazeera America

The Federal Bureau of Investigation is probing a surgical tool found to spread uterine cancer and what Johnson & Johnson knew about its risks before withdrawing its version of the device last year, the Wall Street Journal reported.

J&J said in July that it would ask doctors to return the device, called a laparoscopic power morcellator, which is used to treat uterine growths called fibroids.

It is unclear what stage the inquiry is in, the Journal reported, citing three people who have been interviewed. But the agency has interviewed a retired pathologist who spoke to J&J in 2006 about potential problems with morcellators, a doctor who came forward after her own cancer was exacerbated by the tool and a California woman who collected the names of hundreds of patients who may have been harmed by the tool, the newspaper said.

A J&J spokesman said the company has not been contacted by the FBI regarding its Ethicon morcellation devices.

The U.S. Food and Drug Administration tightened its guidelines on the use of a uterine surgical technique in November, saying it has been linked to the spread of a rare type of cancer.

This came after the agency issued an alert in April last year discouraging the use of the devices to remove fibroids, warning that an estimated that 1 in 350 U.S. women who undergo fibroid procedures each year have a form of cancer called uterine sarcoma.

The devices are used to slice fibroid and uterine tissue into small pieces inside the body, allowing it to be removed through a small opening. The procedure is designed to shorten recovery time and reduce wound-site infections.

Yet the technique can cause injury to local tissues and organs and spread unsuspected malignant tissue to places outside the uterus.

UnitedCare, the nation’s largest health insurer, announced in February that it would place stricter controls on its coverage of hysterectomies amid concerns about laparoscopic surgeries and the spread of undetected cancer.

As of April 6, the insurer requires physicians to obtain authorization before carrying out laparoscopic “keyhole” surgeries and the removal of the uterus via the abdomen, and won’t approve coverage unless they are deemed to be medically necessary.

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Report: FBI investigating medical device that spread cancer in women

May 27, 2015 | CBS News Online

The FBI reportedly is investigating a medical device that was withdrawn from the market last year after it was found to spread cancer in women. The Wall Street Journal reports investigators are looking into what Johnson & Johnson, the largest manufacturer of the device, knew about the problems.

The device, known as a laparoscopic power morcellator, was used by surgeons during certain minimally-invasive hysterectomy procedures or to remove uterine fibroids. The morcellator ground up tissue so it could easily be removed through tiny incisions. But when the device was used on women who had undiscovered uterine sarcoma cancer, it had the effect of spreading cancerous tissue throughout the abdomen and pelvis.

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."In November, the FDA required a strong new warning on the product label.

Ethicon, a division of Johnson & Johnson that made the devices, advised doctors to stop using them and withdrew them from the market, although models made by other companies remain available.

Prior to that, about 60,000 such procedures were performed every year, estimated Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health.

Asked about the investigation, J&J/Ethicon told CBS News they have not been contacted by the FBI regarding morcellation devices.

But at least one of the affected patients has been interviewed by the FBI about her case. Dr. Amy Reed, an anesthesiologist and mother of six, became an outspoken critic of the devices after she 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.

Reed's husband, Dr. Hooman Noorchashm, told CBS News the couple had reached out to the FBI starting in late 2013 and "finally, agents in New Jersey listened." He said they were interviewed last October and again recently about their concerns.

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FBI Investigating Medical Device That Spread Cancer in Some Women

May 28, 2015 | ABC Radio Online

The FBI is investigating whether Johnson and Johnson was aware that a surgical device it manufactured could spread cancer in the women on whom it is used.

Johnson and Johnson is one of the leading manufacturers of the power morcellator — a surgical device that breaks down growths in the uterus so that they can be easily removed. However, in as many as one out of every 350 cases, an unknown cancer is hidden within growths, and the device could potentially worsen the condition.

Johnson and Johnson may have been alerted to to the risks as early as 2006. The company didn’t remove the device from the market, however, until July 2014. In November of that year, the U.S. Food and Drug Administration implemented its most serious warning on the device.

In that FDA warning, the agency noted that the device could “significantly [worsen] the patient’s long-term survival.”

The agency urged against the use of power morcellators.

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Medical device complaint reportedly draws FBI attention

May 28, 2015 | Philadelphia Inquirer

By Marie McCullough

After a surgical device spread an aggressive but undetected uterine cancer inside anesthesiologist Amy Reed in late 2013, she and her husband launched a campaign to ban electric morcellators.

Now, the Federal Bureau of Investigation has gotten involved, according to Reed's husband, Philadelphia cardiologist Hooman Noorchashm, and Sarah Robinson, a California woman whose cancer was also worsened by the device. Both said Wednesday that they have been interviewed by FBI agents, and believe the FBI is looking into whether manufacturers failed to report deaths and serious injuries to the Food and Drug Administration, as required by federal law.

"I had been trying to get the FBI's attention for a very long time," said Noorchashm, a heart surgeon at Thomas Jefferson University Hospital. "The FBI's questions surrounded how much the company knew and, despite knowing, how it continued marketing" the device.

Celeste Danzi, spokeswoman for the FBI in Newark, N.J., said the agency does not confirm or deny the existence of an investigation, which becomes public only if criminal charges are filed.

Johnson & Johnson, the New Brunswick, N.J., maker of the leading morcellator, has not been contacted by the FBI regarding its product, said Matthew Johnson, spokesman for the company's Ethicon division.
He said the device's usage instructions "have always included cautions . . . about the potential spread of malignant or suspected malignant tissue." He noted that J&J voluntarily withdrew the morcellator from the market last July, after the FDA issued new safety warnings.

In April 2014, the FDA warned that women undergoing surgery to remove uterine fibroids - benign growths that can cause bleeding and pain - have a 1 in 350 chance of a hidden cancer, leiomyosarcoma, that preoperative tests can't reliably detect. Before Reed's campaign, the complication was believed to be ultrarare, perhaps 1 in 10,000 women.
Reed had a hysterectomy with morcellation in October 2013 in Boston, where the couple then lived and practiced medicine. Tens of thousands of other women have been treated with the electric device since the first one was marketed in 1993.

Gynecological medical groups say morcellators still have benefits in certain cases, because the electric blade enables tissue to be dissected and removed through small abdominal incisions, reducing recovery time and surgical complications. Nonetheless, leading hospitals and large health plans have restricted or abandoned use of the device over the last year.

Noorchashm said he and his wife have been interviewed by the FBI several times since December.

Robinson, a physician assistant now on disability in Los Altos because of her cancer, said she was interviewed by the FBI about two months ago. She provided the agency a list she has compiled of nearly 400 women who believe their cancers were worsened by power morcellation.

"I think the issue here is that, not only was there a problem with the morcellator that harmed many women, but the FDA has a requirement that manufacturers must report such cases," she said Wednesday. "None were reported until Hooman and I" helped women submit their information to the FDA.

The push for an FDA ban also led Robert Lamparter, a retired pathologist at Evangelical Community Hospital in Lewisburg, Pa., to go public with 2006 correspondence in which he warned Johnson & Johnson's Ethicon subsidiary of the danger of morcellating an undetected cancer - a danger that became apparent to him in his own small hospital.

Lamparter could not be reached for comment Wednesday. But he, too, was interviewed by the FBI, according to Noorchashm. A year ago, Lamparter allowed Noorchashm to share the pathologist's e-mails and letters with the journalists, lawmakers, regulators, and others on Noorchashm's vast e-mail list.

"This morning I had a meeting with my former colleague, Dr. Lawrence Ginsburg, medical director at Evangelical Community Hospital, and presented my dilemma - openly report the information and hopefully save some lives, or stay silent and protect my hospital and friends," Lamparter wrote last May in an e-mail Noorchashm shared. "He was supportive of my decision for disclosure, much to my relief!"

Johnson, the Ethicon spokesman, said Lamparter "contacted the company in 2006 seeking advice on ways to collect and evaluate endometrial specimens following morcellation. His questions prompted Ethicon to revise the precautions contained in the device's instructions for use.

After her leiomyosarcoma diagnosis in October 2013, Reed, now 42, underwent massive surgery and chemotherapy. Still, the cancer recurred early this year, requiring surgery to remove part of her spinal column, followed by radiation. She is now at home in Bucks County with the couple's six children, but plans to return to her job at the Hospital of the University of Pennsylvania next month.

She and Noorchashm have expanded their campaign to push for an overhaul of part of the medical device regulation system, which has been faulted by experts - including the influential Institute of Medicine - for allowing many devices to come to market without being tested for safety or effectiveness.

"The Congress has to change the legislation," Noorchashm said.

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FBI investigating Johnson & Johnson over hysterectomy device pulled from market: report

May 27, 2015 | NY Daily News

By Deborah Hastings

The FBI is questioning makers of a surgical device that can spread cancer cells in female patients, asking Johnson & Johnson officials what the manufacturing giant knew about the tool before yanking it out of service in 2014, according to a new report.

The FBI's Newark, N.J., office is overseeing the probe, the Wall Street Journalreported Wednesday. Johnson & Johnson, a multinational medical company based in New Brunswick, declined comment to the paper.

The device, called a laparoscopic power morcellator, was pulled from the market last year after the FDA recommended not using the surgical tool because it can spread cancerous tissues and cells.

The laparoscopic instrument was a minimally invasive tool for removing fibroids and conducting hysterectomies by chopping the tissues into small pieces that could be removed without major surgery.
For women with certain underlying conditions, the FDA said, the device could actually spread cancer into the abdomen and pelvis.

Three people have been questioned so far in the FBI investigation, the paper said.

They included a retired pathologist who alerted the medical company in 2006 about problems with the instrument and a woman who has gathered a list of nearly 400 patients and their families who may have suffered from the device.

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Widowers welcome morcellation investigation

May 28, 2015 | Rochester Democrat & Chronicle

By Patti Singer

Husbands of two Rochester-area women who died after a procedure worsened their undetected uterine cancers welcomed news of a federal investigation into what manufacturers knew about hazards of the device called a power morcellator.

"Any government investigation by any agency that brings more light to the matter would be a positive or a good thing," said Jim Leary of Greece, whose wife, Barbara, died in September 2013.

"I'm glad to see anybody exploring this in more depth," said Frank Interlichia of Brighton, whose wife, Linda, died in October 2014. "This way the issue isn't going to be forgotten."

A third area woman, Brenda Leuzzi of Perinton, also died in October 2014.

The Wall Street Journal reported Wednesday that the Federal Bureau of Investigation was looking into what Johnson & Johnson, which had been the largest manufacturer of laparoscopic power morcellators, knew about its potential to spread tissue.

According to the Wall Street Journal, the FBI interviewed a pathologist who had corresponded with J&J in 2006. The newspaper also reported that the FBI contacted two women who underwent minimally invasive gynecologic surgery with power morcellation and who later were found to have cancer.

Power morcellation was frequently used in minimally invasive surgery for fibroids, which are presumed to be benign growths. The morcellator devices use high-speed blades to cut tissue so it can be removed through small incisions. However, the determination of cancer is made by a pathologist after surgery. With no way to know for sure that tissue is benign, power morcellators can send cancer throughout the abdominal cavity.

The problem began receiving attention in late 2013, after a doctor in Boston underwent minimally invasive gynecologic surgery with power morcellation and later learned an undetected cancer had been spread. She and her husband began a national campaign to publicize the risk of the procedure.

The Food and Drug Administration, which regulates surgical devices, issued a safety advisory in April, and Rochester hospitals stopped doing power morcellation. J&J recalled the devices in July. The FDA issued a sterner, "black box" warning in November. But it did not ban the device.

At that time, Leary and Interlichia said the FDA decision was weak.

They expressed optimism at the prospect of the FBI investigation.

"I think it will shed more light on the dangers of morcellation and bring more public awareness of the issue," Leary said. "I hope if they do start an investigation, they do it complete and thorough, and wherever it leads them, I hope they follow through with everything and don't get caught up in corporate politics and corporate greed, money over life and safety."

Interlichia said he assumed the FBI would not be investigating unless it had some evidence.

"The fact that it's risen to this level, it certainly doesn't help anybody who's been affected, but it can help more women in the future," he said. "I'm all for it."

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FBI Investigates J&J’s medical device believed to have spread cancer in women

May 28, 2015 | Maine News Online

By Tanya Campbell

The FBI is investigating Johnson and Johnson's surgical device that breaks down growths in the uterus so that they can be easily removed.

The federal officials are probing whether the company already knew that the device known as a laparoscopic power morcellator could spread cancer in women who used it. It was withdrawn from the market last year.

The device was used by surgeons during certain minimally-invasive hysterectomy procedures or to remove uterine fibroids. It grounds up tissue so that it could easily be removed through tiny incisions.

A warning was issued by the US FDA about the cancer risk in April 2014. It said that morcellation could worsen the patient's likelihood of long-term survival. The FDA implemented its most serious warning on the device in November.

The medical device is being made by Ethicon, a division of Johnson & Johnson. It urged doctors to stop its use. When J&J/Ethicon was asked about the investigation it told CBS News they have not been contacted by the FBI regarding morcellation devices.

However, the FBI has interviewed at least one of the affected patients, Dr. Amy Reed, who is an anesthesiologist and mother of six. She underwent a hysterectomy with a morcellator at Boston's Brigham and Women's Hospital in
2013. Follow-up testing showed that she had cancer that had spread through her abdomen.

Reed's husband, Dr. Hooman Noorchashm, said that they reached out to the FBI in late 2013. The agents and in New Jersey finally listened to them. They were interviewed last October about their concerns.

J&J may have been alerted about the risks as early as 2006. However, it didn't remove the device from the market till July 2014.

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FBI investigating J&J for its surgical tool that spreads cancer in women

May 27, 2015 | MedCity News

By Meghana Keshavan

More bad news for the laparoscopic power morcellator.

The FBI is now investigating a surgical device that’s been found to spread cancer cells in women, the Wall Street Journal reports.

This adds to a call for tightening regulations around reusable medical devices from both U.S. insurers and U.S. regulators – particularly apt since the recentUCLA superbug scare.

The morcellator was pulled from the market last year, but investigators are examining how much Johnson & Johnson – the device’s largest manufacturer – knew about the dangers of the tool. The WSJ writes:

Over the past several months, FBI agents have interviewed a retired pathologist who alerted J&J about potential problems with morcellators in 2006, a doctor who went public after her own cancer was worsened by the tool in 2013, and a California woman who has collected names of close to 400 patients and families of patients who may have been harmed by the tool, these people said.

The probe comes after the U.S. Food and Drug Administration warned in Novemberthat morcellators shouldn’t be used on the vast majority of women.

The device’s use has been drastically cut since news of its hazards have emerged – hospitals are either discontinuing or reevaluating their use in patients.

Beforehand, however, it was used in thousands of patients with benign uterine growths and in hysterectomies – the morcellator cut up tissue so it could be extracted in a minimally invasive manner. But in the process, if that tissue were cancerous, it’d spread further within a woman’s abdomen. The WSJ continues:

The FDA warned in April 2014 that women undergoing fibroid surgery have a 1 in 350 chance of harboring dangerous uterine sarcoma that can’t be reliably detected before the operation. Morcellators can spread the malignancy and worsen the outcome, the FDA said. In November, the FDA called for a “black-box” warning—its strongest caution—on the tool.

Notably, morcellators “have alwaysincluded cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue,” J&J spokesman Matthew Johnson said in a statement to the WSJ.

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FBI said to probe devices known to spread cancer in women

May 27, 2015 | Modern Healthcare

By Steven Ross Johnson

Federal investigators are reportedly conducting a probe of medical devices that have been linked to spreading cancer in women.

The Wall Street Journal reports that the FBI is investigating what Johnson & Johnson, at one time the largest manufacturer of laparoscopic power morcellators, knew about the dangers associated with their use before pulling them from the market in 2014.

A spokesman for the FBI's Newark, N.J., office declined to comment Wednesday afternoon and would neither confirm nor deny the existence of an investigation.

A Johnson & Johnson spokesman said the company has not been contacted by the agency regarding an investigation and had no knowledge of any probe.

Until a few years ago, power morcellators were commonly used to cut up and laparoscopically remove fibroids formed in the uterus. Last April the Food and Drug Administration issued a safety communication that warned the devices should not be used in women undergoing hysterectomy or myomectomy procedures because they could spread previously undetected uterine sarcoma, which the agency estimated were found in 1 in 350 cases.

Use of the morcellators for such procedures has gone down steadily among healthcare providers since reports of their adverse effects.

“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 warned. “For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

The agency updated its guidance on power morcellators last November, specifically warning that the use of such devices for laparoscopic uterine procedures carried the risk of spreading cancer.

The Wall Street Journal reported that it was unclear what stage the investigation had reached and whether the probe is specifically targeting Johnson & Johnson or any other makers of morcellators.

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WSJ: J&J target of FBI probe over power morcellator devices

May 27, 2015 | FierceMedicalDevices

By Emily Wasserman

Johnson & Johnson ($JNJ) is facing more pushback over power morcellator devices used in minimally invasive gynecological procedures, as the FBI investigates how much the company knew about the products' risks before pulling them from the market last year.

The Federal Bureau of Investigation's Newark, NJ, office is heading up the investigation, asking patients and physicians about J&J's knowledge of morcellators' potential hazards, three people interviewed by the agency told The Wall Street Journal. J&J is staying mum on the probe, saying it is not aware of an investigation into power morcellator devices, according to the WSJ story. The FBI's Newark, NJ-based office declined to comment to the newspaper.

Over the past several months, FBI agents interviewed Dr. Robert Lamparter, a former pathologist at Lewisburg, PA-based Evangelical Community Hospital, about his 2006 correspondence with J&J's Ethicon subsidiary about its power morcellator devices. Lamparter reportedly told Dr. David Robinson, Ethicon's medical director at the time, that he was concerned with several issues including the risk of spreading undetected cancer with the devices. But Lamparter never cited a specific case of this happening, the WSJ reports.

J&J acknowledged its correspondence with Lamparter, saying his concerns spurred the company to revise its instructions for the device. And Ethicon morcellators "have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue," J&J spokesman Matthew Johnson told the WSJ.

Still, the FBI probe does not bode well for the company as it continues to deal with the fallout over related products. In April 2014, J&J suspended sales of its morcellator devices after the FDA warned of risks associated with the tools. In July 2014, J&J pulled its morcellator devices from the global market in light of more public and regulatory pushback.

Meanwhile, the FDA is weighing in on the devices' safety through updated guidance. In November, the agency slapped power morcellators with a "black-box" warning--its strongest caution--recommending against using the tools in the "majority" of women undergoing a hysterectomy for the removal of uterine fibroids. But the FDA has stopped short of banning morcellators altogether, saying the devices' benefits may outweigh the risks in some women.

- read the WSJ story (sub. req.)

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Health Highlights: May 28, 2015

May 28, 2015 | HealthDay

Health Highlights: May 28, 2015

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Cancer-Spreading Hysterectomy Device Focus of FBI Investigation

A hysterectomy device found to spread uterine cancer is the focus of an FBI investigation.

Among other things, the agency wants to know what Johnson & Johnson -- the largest manufacturer of the surgical tool called a laparoscopic power morcellator -- knew about the device's potential risks before halting sales last year, according to three people who have been interviewed by the FBI, the Wall Street Journal reported.

Last November, the U.S. Food and Drug Administration warned that morcellators shouldn't be used on most women.

The FBI declined to comment about the probe and a Johnson & Johnson spokesman said the company isn't aware of an investigation into the device, WSJ reported.

People interviewed by the FBI include a retired pathologist who informed Johnson & Johnson about potential problems with the morcellator in 2006, a doctor whose uterine cancer was worsened by the tool, and a woman who has gathered the names of nearly 400 patients and family members of patients who may have been harmed by the morcellator.

The device -- which was used in tens of thousands of procedures a year, mainly hysterectomies -- cuts up benign uterine growths called fibroids so the tissue can be removed through tiny incisions, WSJ reported.

However, morcellators can put patients at risk by spreading undetected uterine cancer, according to the FDA.
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Live Anthrax Spores Sent Accidentally to U.S. Labs

The Pentagon accidentally shipped live anthrax spores to government and commercial laboratories in at least nine states and one overseas location, the U.S. Centers for Disease Control and Prevention said Wednesday.

All of the labs had expected to receive dead anthrax spores for testing purposes, theAssociated Press reported.

"At this time, we do not suspect any risk to the general public," CDC spokeswoman Kathy Harben told the wire service.

The U.S. government has confirmed that one lab in Maryland received live spores. Officials suspect, but have not yet confirmed, that anthrax samples sent to labs in eight other states also contained live spores, the Associated Press reported.

The other eight states were Texas, Wisconsin, Delaware, New Jersey, Tennessee, New York, California and Virginia, the wire service said.

Another anthrax sample from the same batch was sent to a U.S. military laboratory at Osan air base in South Korea; no personnel there have shown signs of exposure, he said, and the sample was destroyed, according to the AP.

Shipment of the samples has been halted until an investigation has been completed, officials told the AP.

Contact with anthrax spores can cause severe illness. Harben said that all samples involved in the investigation will be securely transferred to the CDC or other laboratories for further testing.

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FBI Probing Power Morcellators, WSJ Reports

May 28, 2015 | MedScape Medical News

By Robert Lowes

The FBI is investigating power morcellators, the surgical tool in widespread disfavor because it can spread occult uterine cancers during gynecologic procedures, the Wall Street Journal (WSJ) reported today.

The WSJ quoted three individuals who said they had been questioned by the FBI over the past several months about morcellators, which are used to shred uterine tissue for easy removal through laparascopic incisions. One of the sources was Amy Reed, MD, an anesthesiologist who underwent a hysterectomy for fibroid removal in 2013 only to discover that morcellation had upstaged an occult uterine cancer. Dr Reed and her husband Hooman Noorchashm, MD, have campaigned to ban the use of the devices to save women’s lives.

In an interview with Medscape Medical News, Dr Noorchashm said that he began asking the FBI in late 2013 to investigate the failure of morcellator manufacturers and healthcare providers to report adverse events such as his wife’s upstaged cancer — and the deaths of other women who had been treated with a morcellator — to the US Food and Drug Administration, a requirement of federal law. The investigation commenced, he said, once the FBI office in Newark, New Jersey, started to take the case seriously last fall.

Another person interviewed by the FBI, the WSJ said, was a pathologist who said he warned one manufacturer of power morcellators, the Ethicon division of Johnson & Johnson’s (J&J), in 2006 about the danger of dispersing occult cancer. A J&J spokesperson told the WSJ that it revised the instructions for its power morcellators to include a statement about this risk.

J&J announced in July 2014 that it was voluntarily withdrawing its power morcellators from the worldwide market after the FDA warned three months earlier that the devices could upstage occult cancer. The agency said at the time that 1 in 350 women undergoing hysterectomy or myomectomy for fibroid removal has an unsuspected uterine sarcoma. Other morcellator manufacturers have kept their products on the market.

The third person contacted by the FBI was a physician assistant in California who had a cancer upstaged after power morcellation, according to the WSJ. She gave the agency a list of names of other women and families of women who experienced what she did. Many women on the list died as a result.

Dr Noorchashm told Medscape Medical News that he introduced the FBI to the pathologist and physician assistant.

A spokesperson for the FBI Newark’s office said she could not confirm or deny whether it was conducting an investigation or not. A spokesperson for J&J’s Ethicon division said the company had not been contacted by the FBI regarding the morcellators it once marketed.

Since Dr Reed’s medical case first made headlines in early 2014, the healthcare industry has been retreating from the use of power morcellators, which now bear an FDA-mandated boxed warning about the risk of dispersing occult cancer. Several major health insurers have withdrawn or restricted coverage of morcellation, and fewer surgeons are using the device, according to America’s Health Insurance Plans.

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FBI reportedly investigating J&J medical device

May 28, 2015 | Healthcare Packaging

By Michelle Maskaly

The FBI is reportedly investigating a Johnson & Johnson-made hysterectomy device that can spread cancer in female patients, according to multiple news reports.

Originally reported in the Wall Street Journal, a FBI office in New Jersey is allegedly looking into what the company may have known about the laparoscopic power morcellator.

The agency is, "looking into what the largest manufacturer of it, Johnson & Johnson, knew about the tools and hazards before pulling it off the market last year, according to people who have been interviewed by the agency," according to the Wall Street Journal report.

Last year the FDA pulled the laparoscopic power morcellator, a minimally invasive medical device that is used during hysterectomies, off the market because of the cancer risks.

The FBI declined to comment on the matter to the Wall Street Journal, and told The New York Times for their story, "we just don’t comment on the existence or nonexistence of any investigation."

Johnson & Johnson has told several news outlets, including the New York Daily News, they are not aware of an investigation.

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Johnson & Johnson Laparoscopic Power Morcellator Lawsuits Filed Over Cancer Spread In Women

May 28, 2015 | Inquistr

Lawsuits over a Johnson & Johnson laparoscopic power morcellator has the FBI investigating the surgical device found to be responsibility for spreading cancer in women. It’s also suspected that Johnson & Johnson knew about the device’s hazards prior to yanking it off the market in 2014, according to The Wall Street Journal.

The Federal Bureau of Investigation’s Newark office in New Jersey is overseeing the investigation.

All of this began after the FDA warned last November that morcellators shouldn’t be used on a majority of women. The Johnson & Johnson laparoscopic power morcellator was used in thousands of minimally invasive procedures each year. The device eliminated benign uterine growths — known as “fibroids” — so that tissue could be removed through very small incisions. This practice was widely used in hysterectomies.

It was reported that that 1 in 350 women undergoing fibroid surgery had a chance of harboring dangerous uterine sarcoma that “can’t be reliably detected before the operation.” Instead, morcellators can spread the malignancy and make the outcome worse, the FDA claimed. The FDA called for its strongest warning on the device, known as a “black-box.” Later on, Johnson & Johnson took the tools off the market, but other mocellator manufacturers kept theirs on sale.

Robert Lamparter is a former pathologist at Evangelical Community Hospital in Lewisburg, Pennsylvania and spoke with the FBI interviewed about his 2006 correspondence with the Johnson & Johnson subsidiary that sold the power morcellators. He wrote about his concern regarding several issues, which didn’t exclude the potential for an “undetected cancer to be inadvertently spread by the surgical instrument.”

Lamparter’s small hospital performed 292 hysterectomies the previous year and gynecologists discovered an unexpected malignancy at least once a year after that. This led to suspicion of the device even further.

J&J spokesman, Matthew Johnson, said the company is “continually assessing the totality of the available data and information—including peer-reviewed studies and scientific literature, as well as physician feedback—related to our products.”

Johnson also confirmed the 2006 correspondence with Dr. Lamparter prompted the company to revise the instructions for the laparoscopic power morcellator.

About Lawsuits includes the facts in its report that numerous women of uterine fibroid morcellation lawsuits are now “being pursued on behalf of individuals diagnosed with leiomyosarcoma, endometrial stromal sarcoma or other cancers spread following a hysterectomy or myomectomy performed laparoscopically or through robotic surgery.

“Plaintiffs allege that as they were originally designed and sold, power morcellators are unreasonably dangerous.”

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FBI investigating surgical tool suspected of 'spreading cancer in women'

May 28, 2015 | Daily Mail Online (UK)

By Julian Robinson

The FBI is investigating a surgical tool found to spread uterine cancer in women, it has been reported.

Pharmaceutical giant Johnson & Johnson said in July last year that it would ask doctors to return the device, which is used to treat growths called fibroids.

But investigators are now reportedly probing what the US firm knew about the risks of the laparoscopic power morcellator before withdrawing its version of the device.

A J&J spokesman said the company has not been contacted by the FBI regarding its Ethicon morcellation devices. The firm is the largest producer of the device, according to the Wall Street Journal.

The U.S. Food and Drug Administration tightened its guidelines on the use of a uterine surgical technique in November, saying it has been linked to the spread of a rare type of cancer.

This came after the agency issued an alert in April last year discouraging the use of the devices to remove fibroids.

The tool is used to slice fibroid and uterine tissue into small pieces inside the body, allowing it to be removed through a small opening.

The procedure is designed to shorten recovery time and reduce wound-site infections.

Yet the technique can cause injury to local tissues and organs and spread unsuspected malignant tissue to places outside the uterus.

According to CBS News, at least one of the affected patients has been questioned about her case by FBI agents.

Dr Amy Reed underwent a hysterectomy with a morcellator in Boston two years ago, but tests afterwards revealed she had cancer that had spread across her abdomen, the website reports.

Her husband Dr Hooman Noorchashm told CBS News how they had contacted the FBI in 2013 and were interviewed last fall and again recently.

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