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Morcellation Media Monitoring 10/8/2015
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Warning For Women Over Medical Device
Oct 7, 2015 | NBC Houston Clip
By Haley Hernandez
Video Clip here: http://beta.criticalmention.com/app/#clip/view?16624474/token/f2029cba-5276-43b2-ae67-44c89c7dc581 Rough Transcript: It's a device doctors have used thousands of time to help women get relief from painful fibroids. but now there's a serious warning. >> women are being diagnosed with cancer months after the procedures. 11:15 PM haley hernandez is here to explain the surgery. >> reporter: that's right. this is the device. it's used to treat uterine fibroids and the f.d.a. says that one in 350 women undergoing treatment of fibroids is found to have an unsuspected cancer. and this device may end up spreading cancer during the procedure. 39-year-old april johnson is in a battle for her life. -
Treatment for fibroids suspected of spreading cancer
Oct 7, 2015 | NBC Houston
By Haley Hernandez
The Food and Drug Administration said 1 in 350 women undergoing a hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected cancer. They said there is a risk that using a morcellator to remove them will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. -
Investigation Launched into FDA Morcellator Approval Process
Oct 6, 2015 | Top Class Actions
By Ashley Vanover
A bipartisan team of lawmakers is calling on the U.S. Government Accountability Office (GAO) to find out why it took the Food and Drug Administration (FDA) decades to realize that power morcellators pose serious cancer-spreading risks for women undergoing hysterectomies. -
Dr. Reed Speaks Out On Behalf Of Power Morcellator Lawsuit Plaintiffs
Oct 8, 2015 | The Legal Herald
By Laurence Banville
Dr. Reed and her husband, Dr. Hooman Noorchashm, have approached the FBI and GAO regarding power morcellator regulations. In 2013, Dr. Amy Reed was diagnosed with uterine cancer following an operation to remove her uterine fibroids. She and her husband, Dr. Hooman Noorchashm, believe that her cancer was upstaged and spread by the power morcellator used during her procedure. Since her diagnosis, they have both dedicated their time to speaking out against morcellation during gynecological surgeries and warning other women of the risks. -
Power Morcellator Lawsuit Update: Manufacturing Companies Fight MDL
Oct 7, 2015 | Press Release
By Tracey & Fox
Tracey & Fox has reported that four power morcellator manufacturing companies have filed briefs arguing against the consolidation of all morcellator lawsuits, and have also presented their arguments before the U.S. Judicial Panel on MultiDistrict Litigation. -
Following Power Morcellator Lawsuit FDA Convenes Panel To Review Device
Oct 5, 2015 | Press Release
By Tracey & Fox
Tracey & Fox has commented on the panel convened by the U.S. Food and Drug Administration to review the risks associated with the use of a power morcellator. -
Another Power Morcellator Lawsuit Plaintiff Dies
Oct 6, 2015 | Press Release
By Tracey & Fox
Tracey & Fox has announced that another morcellator lawsuit plaintiff has passed away. The plaintiff filed her lawsuit on April 7th, 2015 in the United States District Court Northern District of Georgia Atlanta Division under case number 1:15-cv-01046-ODE. She died just twelve days later on April 19th, 2015. -
Judicial Panel Discusses Consolidation Of Power Morcellator Lawsuits
Oct 7, 2015 | Righting Injustice
By Jennifer Walker-Journey
The U.S. Judicial Panel on Multidistrict Litigation is meeting this week to determine whether it would be beneficial to consolidate lawsuitsinvolving similar allegations against the manufactures of power morcellators, medical devices used to perform some gynecological procedures including hysterectomies and uterine fibroid removal. The lawsuits allege that the devices can spread undiagnosed uterine cancer, worsening a woman’s odds of survival.
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Warning For Women Over Medical Device
Oct 7, 2015 | NBC Houston Clip
By Haley Hernandez
Video Clip here: http://beta.criticalmention.com/app/#clip/view?16624474/token/f2029cba-5276-43b2-ae67-44c89c7dc581
Rough Transcript It's a device doctors have used thousands of time to help women get relief from painful fibroids. but now there's a serious warning.
>> women are being diagnosed with cancer months after the procedures. 11:15 PM haley hernandez is here to explain the surgery.
>> reporter: that's right. this is the device. it's used to treat uterine fibroids and the f.d.a. says that one in 350 women undergoing treatment of fibroids is found to have an unsuspected cancer. and this device may end up spreading cancer during the procedure. 39-year-old april johnson is in a battle for her life.
>> weak, tired, sometimes i would be sick and i couldn't get out of bed.
>> reporter: it started when she went to the doctor suffering from something many women experience, pain caused by uterine fibroids.
>> i was anemic from it.
>> reporter: april's doctor suggested she have a hysterectomy. this device was supposed to leave a smaller scar.
>> it was pretty much this is what we're going to do. it's easy, recovery time is easier.
11:16 PM>> reporter: it works by shredding the fibroids inside the uterus, but the results have been devastating for women across the country who say it left behind tissue. tissue that in some cases was cancerous. and that the device spread the cancerous cells.
>> i represent about 50 women right now and all of my cases are similar in that none of these companies did any testing before they took this to ma joorkt sean tracy is suing companies selling the device.
>> literally hundreds and hundreds of women have died and they have no idea whether they were more -- their families have no idea. they just know that their wife or mother or daughter is dead.
>> reporter: april was diagnosed with a rare form of uterine cancer just a month after her procedure.
>> i was not using -- if they had not used this and just took 11:17 PMthe uterus, i would not have this. it spread to my abdomen al wall.
>> reporter: the f.d.a. issued a warning in 2014 for these devices. it states they may spread cancer and decrease the long-term survival of patients and should not be used for removal of uterine tissue containing suspected fibroids in certain patients. johnson & johnson pulled the device from the market just weeks later. but four other manufacturers still sell it and it's still being used by doctors.
>> i mean, how anybody would ever think it was a good idea to go in there with essentially a mini food processor and blend up and scatter cancer cells over a woman's abdomen is beyond me! i mean, it's -- it's unbelievable.
>> reporter: in a statement to channel 2, johnson & johnson wrote, we will defend ourselves in the lawsuits that have been filed against us. we sympathize with any women and their families who have suffered the spread of a preexisting malignancy following surgical treatment.
>> i have children. i have to think about. if something was to happen -- somebody would happen to me tomorrow, where does that leave myner teen-year-old.
>> reporter: i asked -- my 13-year-old.
>> reporter: i asked several hospital physical they've ever used this device. md anderson says it has never used it, but the woman's hospital of texas used it until the warning was issued last year.
>> so for women who are going in to have fibroids removed, what should they ask their doctor?
>> reporter: you need to ask if the device is being used. we couldn't check with every doctor in every facility, but if you ask them that that should help you narrow it down. and you can weigh your pros and cons from. next ask if the device that's being used would leave tissue behind and what risk that is would pose. we put the full f.d.a warning on click2houston.com/health.
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Treatment for fibroids suspected of spreading cancer
Oct 7, 2015 | NBC Houston
By Haley Hernandez
The Food and Drug Administration said 1 in 350 women undergoing a hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected cancer. They said there is a risk that using a morcellator to remove them will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.
April Johnson, 39, is in a battle for her life.
“(I'm) weak (and) tired. Sometimes I would be sick to the point to where I couldn't even get out of bed,” Johnson said.
It started in 2014 when the mother of two went to the doctor, suffering from something many women experience -- pain caused by uterine fibroids.
“To the point I was anemic from it,” she said.
Johnson's’ doctor recommended she have a procedure to remove the fibroids and end her pain. Using a morcellator was supposed to be less invasive and leave a smaller scar.
“It was pretty much a, 'This is what we're going to do, it's easier, the recovery time is easier,’” Johnson said.
The morcellator works by shredding the fibroids inside the uterus, but the results have been devastating for women across the country who say it left tissue behind, tissue that in some cases was cancerous, and the morcellator spread those cancerous cells.
“I represent 50 women right now and all of my cases are similar in that none of these companies did any testing before they took this to market. They didn't do any animal testing, they did no human testing,” said Sean Tracey, a Houston attorney suing companies selling the morcellator, including Johnson & Johnson’s Ethicon.
“Literally hundreds and hundreds of women have died and they have no idea whether they were morcellators. Their families don't know,” he said. “They just know that their wife, or mother or daughter is dead.”
Johnson was diagnosed with a rare form of uterine cancer just a month after her procedure.
“If they would have not used the morcellator, and just took the uterus, I wouldn't have had to go through chemo, because when they used the morcellator, it spread to my abdominal wall,” she said.
In April 2014, the FDA issued what's known as a black box warning for morcellator devices.
The warning states, "When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
Johnson & Johnson pulled the morcellator from the market just weeks later, but four other manufacturers still sell it and it's still used by doctors.
“In retrospect, this is so obviously a disaster. I mean, how anybody would ever think it's a good idea to go in there with essentially a mini-food processor and blend up and scatter cancer cells over a woman's abdomen is beyond me. It's unbelievable,” Tracey said.
In a statement to KPRC 2 News, Johnson & Johnson wrote, "Our powered morcellation devices always have carried a warning about the potential spread of cancerous tissue. As the medical community’s understanding of the risk of undiagnosed malignancies prior to uterine surgery evolved last year, we elected to suspend sales and then to voluntarily withdraw our morcellator devices from the marketplace. We remain the only manufacturer to have taken these proactive steps. Because Ethicon acted appropriately and responsibly at all times in relation to our morcellation devices, we will defend ourselves in the lawsuits that have been filed against us. We sympathize with any women and their families who may have suffered the spread of a pre-existing malignancy following surgical treatment for gynecologic conditions.”
Like many patients, Johnson didn't think to ask too many questions about the specific device used in her procedure, but with other devices like the morcellator still used in surgeries, women undergoing a hysterectomy need to ask their doctors how the procedure will be done.
“I have children that I have to think about," Johnson said. "If something was to happen, I mean, God please, hope it don't, but if something was to happen to me tomorrow, where does that leave my 13-year-old?”
Anyone who is looking at treatment options for fibroids should ask if a power morcellator is being used in the surgery. Then ask if the device being used will leave tissue behind and the possible risk that poses.
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Investigation Launched into FDA Morcellator Approval Process
Oct 6, 2015 | Top Class Actions
By Ashley Vanover
A bipartisan team of lawmakers is calling on the U.S. Government Accountability Office (GAO) to find out why it took the Food and Drug Administration (FDA) decades to realize that power morcellators pose serious cancer-spreading risks for women undergoing hysterectomies.
The Wall Street Journal is reporting that twelve members of Congress sent a letter demanding an investigation of the FDA’s approval and monitoring of morcellators.
At least 10 power morcellators were approved in the last 24 years. However, it was not until “decades after some studies were already pointing to a serious problem” that the FDA realized the risk of spreading cancer was much higher than expected.
According to the letter reviewed by the WSJ:
“The FDA, the medical device industry, and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-10,000 . . . How did they get it wrong for so long?”
Power Morcellation Cancer
In the general population, about one in 10,000 women has undiagnosed uterine cancer. However, women who choose to have a hysterectomy are not the general population — they are usually choosing to have a hysterectomy to treat pain, bleeding, large fibroids, or other symptoms that could also be cancer.
For women being treated with a morcellator during a hysterectomy, about 1 in 350 has undiagnosed cancer. Unfortunately, there is no way of knowing whether a fibroid is actually cancer until after the hysterectomy.
In November 2014, the FDA issued a Safety Communication to warn that morcellators should not be used on the “vast majority” of women. However, no recalls were issued and many manufacturers continue to sell the controversial medical devices.
FDA Under Scrutiny for Morcellator Approval Process
For the FDA, medical devices fall into one of three categories: Low-risk products (think tongue depressor) see little regulatory oversight for obvious reasons; High-risk devices, like implantable products, are scrutinized with the same caution reserved for pharmaceutical drugs, including large-scale clinical trials and sometimes years of medical board review.
But power morcellators fall into the middle-ground of moderate-risk devices. Apparently more dangerous than a low risk product, but less dangerous than something implanted inside the body, moderate-risk devices are eligible for the 501(k) clearance process.
501(k) is a sort of “fast track” approval process. If a device manufacturer can demonstrate that its new product operates similarly to a pre-existing device, it can be cleared for market without any need for new safety testing. In other words, manufacturers don’t need to demonstrate the safety of their products, even if they’re being cleared for completely new uses.
However, in April 2014, the U.S. Food & Drug Administration (FDA) warned that morcellators could “significantly worsen . . . the patient’s likelihood of long-term survival.” Last November, the agency required manufacturers to include a black box warning on the labeling of their morcellators, leaving many to wonder how the devices were allowed to be fast-tracked for approval.
Despite these recent events, the FDA is adamant that the 510(k) process is fair and safe.
Dangers and Risks of Power Morcellators
Morcellators are used during minimally-invasive gynecological procedures, such as hysterectomy surgeries and fibroid removal. The device pulverizes tissue so it can be removed through tiny incisions. However, when morcellators are used on women who have undetected uterine sarcoma cancer, they can spread cancerous tissue throughout the abdomen and pelvis.
As the significant dangers of power morcellation gain further attention, public scrutiny has been thrown far and wide.
Under increasing pressure, many insurance companies have opted to limit coverage for procedures involving the dangerous devices. At least one power morcellator manufacturer, Johnson & Johnson’s Ethicon subsidiary, has seen fit to pull its products from the market and many health insurers refusing coverage for power morcellation surgeries.
Individual doctors and hospitals have not escaped criticism either, with several patients filing personal injury lawsuits against both device manufacturers and the surgeons who chose to use power morcellators.
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Dr. Reed Speaks Out On Behalf Of Power Morcellator Lawsuit Plaintiffs
Oct 8, 2015 | The Legal Herald
By Laurence Banville
Dr. Reed and her husband speak out against power morcellators
Dr. Reed and her husband, Dr. Hooman Noorchashm, have approached the FBI and GAO regarding power morcellator regulations. In 2013, Dr. Amy Reed was diagnosed with uterine cancer following an operation to remove her uterine fibroids. She and her husband, Dr. Hooman Noorchashm, believe that her cancer was upstaged and spread by the power morcellator used during her procedure. Since her diagnosis, they have both dedicated their time to speaking out against morcellation during gynecological surgeries and warning other women of the risks.
FBI InterviewDr. Reed even reached out to the Federal Bureau of Investigations regarding her concerns and has reported that agents in New Jersey have interviewed her twice. She and her husband also spoke with members of Congress, and convinced twelve of them to sign a letter requesting that the U.S. Government Accountability Office investigate the U.S. Food and Drug Administration’s 501(k) approval process.
The FDA first granted approval for the power morcellator in 1991 under the 501(k). This allowed morcellator manufacturers to put the device on the market without performing any safety testing because they claimed the tool was “substantially equivalent” to a previously approved surgical tool. However, the FDA ended up warning against the use of the morcellator when they released a safety warning in April 2014.
GAO’s DecisionThe GAO has responded to the letter from Congress, agreeing to investigate the 501(k) process and determine if the FDA should continue to approve new devices in this manner. It will be several months before the investigation begins.
The Problems With The MorcellatorMany are wondering why the FDA approved the morcellator for use in the first place. The FDA claims that even though the surgical tool has been used for decades, it wasn’t until 2013 that they became aware of the risks.
The biggest risk associated with morcellation is for women who are undergoing hysterectomies or myomectomies to treat uterine fibroids. While the majority of fibroids are benign, the FDA has determined that nearly 1 in 350 women undergoing these procedures also has undiagnosed uterine cancer. If the morcellator is used, it might disseminate cancer cells throughout the abdominal cavity and upstage the cancer. In the past two years, over 30 women and their families have filed lawsuits against power morcellator manufacturers, all alleging that a morcellator spread their undetected uterine cancer. -
Power Morcellator Lawsuit Update: Manufacturing Companies Fight MDL
Oct 7, 2015 | Press Release
By Tracey & Fox
Tracey & Fox has reported that four power morcellator manufacturing companies have filed briefs arguing against the consolidation of all morcellator lawsuits, and have also presented their arguments before the U.S. Judicial Panel on MultiDistrict Litigation.
On October 1st, the panel heard arguments from both the plaintiffs and the defendants in the power morcellator debate. Four companies, Johnson & Johnson, Karl Storz GmbH, Richard Wolf GmbH, and Gyrus ACMI all argued that consolidating the lawsuits would not be a good decision.
The defendants are arguing several points. They argue that because of the number of manufacturing companies involved, the differences between the power morcellators used, and the numerous kinds of uterine and ovarian cancer named, a MDL would confuse the issue instead of streamlining the process.
Morcellators are surgical tools that have been approved for use by the U.S. Food and Drug Administration for several decades. The tool made it through a 501(k) approval process, which allows device manufacturers to forgo safety testing if they can prove the tool is “substantially equivalent” to a previously approved device.
In a shocking move, the FDA released a safety warning in April 2014, which it later updated in November 2014, urging doctors to reconsider the use of the morcellator during gynecological surgeries. The updated warning states, “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 long-term survival.” The FDA then estimated that around 1 in 350 women who undergo a hysterectomy or myomectomy has undiagnosed uterine cancer.
Each of the lawsuits filed against a morcellator company alleges that when the tool was used during a gynecological surgery, the cutting jaws of the tool disseminated undetected uterine cancer to other areas of the body cavity. Nine of the women have passed away from uterine cancer during the course of litigation, and their families have continued to pursue the lawsuit on their behalf.
Only one of the more than 30 cases has reached settlement, the very first lawsuit which as filed in the U.S. District Court for the Eastern District of Pennsylvania under case number 5:14-cv-1557 on March 14th, 2014. The case was set to go to trial on November 3rd, 2015, but it was announced in July that the plaintiff had agreed to a settlement of an undisclosed amount.
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Following Power Morcellator Lawsuit FDA Convenes Panel To Review Device
Oct 5, 2015 | Press Release
By Tracey & Fox
Tracey & Fox has commented on the panel convened by the U.S. Food and Drug Administration to review the risks associated with the use of a power morcellator.
A few months prior, the FDA had released a safety warning indicating that they had determined that there was a possible serious risk associated with the morcellator. The warning stated that if the power morcellator was used during a gynecological surgery, and the patient had undetected uterine cancer, the device might spread the cancer to other areas of the body. From July 10th - 11th, the FDA’s Obstetrics and Gynecology Devices Panel met to “seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data.”
The panel findings were ultimately inconclusive, although the panel suggested that surgeons use every available resource to diagnose uterine cancer prior to surgery.
Many were outraged by the FDA’s failure to ban the use of the power morcellator, including Dr. Amy Reed who has been speaking out against the morcellator since 2013. Dr. Reed alleges that her own uterine cancer was spread and upstaged by the power morcellator and, as a result, she has had to undergo extensive chemotherapy and radiation treatments. In her shock after the panel’s announcement, she suggested that the gynecologists on the panel should be held criminally liable for defending the morcellator.
Since the public has been made aware of the dangers of the morcellator nearly 30 lawsuits have been filed against multiple manufacturing companies. Each case alleges that the use of a morcellator during a hysterectomy or myomectomy spread undiagnosed uterine cancer. Each plaintiff has had to undergo chemotherapy treatments and, in some cases, the plaintiff has passed away leaving loved ones behind.
Following the panel’s decision, Johnson & Johnson announced that they were voluntarily withdrawing all of their morcellators from the market, and sent a letter urging doctors around the globe to return the device. At this time, none of the other manufacturers have withdrawn their products.
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Another Power Morcellator Lawsuit Plaintiff Dies
Oct 6, 2015 | Press Release
By Tracey & Fox
Tracey & Fox has announced that another morcellator lawsuit plaintiff has passed away.
The plaintiff filed her lawsuit on April 7th, 2015 in the United States District Court Northern District of Georgia Atlanta Division under case number 1:15-cv-01046-ODE. She died just twelve days later on April 19th, 2015.
Her complaint, like many others, alleges that the use of a power morcellator during her total laparoscopic hysterectomy spread undetected uterine cancer. Her surgery was performed on January 20th, 2011, at Piedmont Hospital in Atlanta, GA. Prior to her surgery, she underwent routine testing which did not give any indication she had cancer. However, her pathology report showed evidence of endometrial stromal sarcoma and leiomyosarcoma.
Her husband has pursued the lawsuit against Johnson & Johnson, the makers of the morcellator used during her surgery, on her behalf. On June 18th, 2015, he joined five other plaintiffs in filing a motion before the United States Judicial Panel on MultiDistrict Litigation, requesting all morcellator lawsuits be consolidated in the U.S. District Court for the District of Kansas under the Hon. Kathryn H. Vratil.
In the last two years, the public and the medical community were made aware of the risks associated with morcellation during a gynecological surgery. The U.S. Food and Drug Administration published a safety warning on April 17, 2014, indicating that if the morcellator was used to cut through uterine fibroids which encapsulated uterine cancer, the morcellator could potentially spread the cancer to other areas of the body.
Following this warning, Johnson & Johnson decided to voluntarily withdraw all of their morcellators from the market, and mailed a letter globally to countless surgeons, requesting that they stop using the device and return it until further safety studies could be performed.
Many have questioned why it took so long for the associated risks to be discovered considering the morcellator has been used by surgeons for over two decades. Recently, it was announced that the U.S. Government Accountability Office had agreed to investigate the process through which the FDA approved the morcellator. This could potentially bring big changes to the FDA’s approval process called a 501(k), which does not require safety testing if a device can be shown to be “substantially equivalent” to a previously approved device.
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Judicial Panel Discusses Consolidation Of Power Morcellator Lawsuits
Oct 7, 2015 | Righting Injustice
By Jennifer Walker-Journey
The U.S. Judicial Panel on Multidistrict Litigation is meeting this week to determine whether it would be beneficial to consolidate lawsuitsinvolving similar allegations against the manufactures of power morcellators, medical devices used to perform some gynecological procedures including hysterectomies and uterine fibroid removal. The lawsuits allege that the devices can spread undiagnosed uterine cancer, worsening a woman’s odds of survival.
The consolidation of lawsuits under one single judge, known as amultidistrict litigation, or MDL, was requested by plaintiffs who have already filed lawsuits against power morcellator manufacturers.
MDLs are generally sought to streamline early trial proceedings when several lawsuits with similar allegations have been waged against a defendant or defendants. Each lawsuitremains an individual lawsuit in the event a settlement is not reached, in which case the lawsuit would be remanded back to its original court.
Plaintiffs have requested the power morcellator MDL be located in the U.S. District Court in Kansas.
Power morcellators are surgical tools that are fitted with a tube-like blade that shreds uterine growths or entire uteruses within the uterine cavity and removes the pieces of tissue through a small incision in the abdomen. The procedures have been used for two decades, but in recent years advocates have argued that the devices can toss bits of cancerous tissue throughout the abdominal cavity, making the disease more difficult to treat.
Some uterine cancers, including uterine sarcoma, are difficult to diagnose before tissue is removed. About 1 in 350 women have uterine cancer and are at risk of cancer spread if they undergo power morcellation procedures.
Last fall, the Food and Drug Administration (FDA) recommended that power morcellators not be used in most women due to the risk of cancer spreading and worsening.
Lawsuits continue to be filed against the manufacturers of power morcellators by women injured by the devices and their family members.
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