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Morcellation Media Monitoring 2/17/2015
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How Suspect Device Got Surgeon Group’s Blessing
Feb 17, 2015 | Wall Street Journal
By By Joseph Walker and Jennifer Levitz
Last May, as controversy mounted over a surgical device called the power morcellator, a professional association for surgeons issued a report defending the tool. A month earlier, the U.S. Food and Drug Administration had warned the device risked spreading cancer in surgeries such as hysterectomies. But the May report, from the AAGL—formerly known as the American Association of Gynecologic Laparoscopists—said morcellation “remains safe when performed by experienced, high-volume surgeons.” -
The AAGL and Morcellators
Feb 16, 2015 | Wall Street Journal Blog
By Jennifer Levitz
The AAGL–formerly known as American Association of Gynecologic Laparoscopists–faces increased public attention because of the controversy over a device called the power morcellator. -
Noorchashm on Morcellation, Patient Safety and Ethics
Feb 13, 2015 | YouTube
By Dr. Hooman Noorchashm
**Note: Dr. Hooman Noorchashm posted a video on his personal YouTube page of his lecture at Thomas Jefferson Medical College in Philadelphia, PA. The lecture focused on morcellation and the FDA's role in patient safety and ethics. The video of the lecture is available at https://www.youtube.com/watch?v=iI382zgwGOo ** -
Power Morcellators are Dangerous and Spread a Rare and Deadly Form of Cancer
Feb 13, 2015 | Lister Frost Injury Lawyers
Power morcellators are widely used as a minimally-invasive procedure in opposition to a surgical hysterectomy or myomectomy to remove the uterus laparascopically. The power morcellator is a small-bladed instrument that cuts the uterus into small pieces so that those pieces can be extracted. When the power morcellator cuts the uterus, it also cuts the sarcomas, thereby spreading the sarcomas to the abdominal cavity. Because no reliable method exists to distinguish a fibroid tumor from a sarcoma, the FDA has stated that 1 in 350 women have unsuspected and undiagnosed uterine sarcoma. Further, the FDA has estimated that the power morcellator spreads the cancer in up to 65% of the cases. -
Cancer Victim Files Morcellator Lawsuit Against Karl Storz
Feb 13, 2015 | Top Class Actions
By Ashley Vanover
A Michigan woman who was diagnosed with stage-4 bone and breast cancer has filed a lawsuit against Karl Storz Inc., the manufacturer of a power morcellator that allegedly spread cancer during her hysterectomy. -
Morcellator Cancer Lawsuit Spreads
Feb 12, 2015 | Citizens Report
An increasing number of lawsuits are being filed against the manufactures of a device used in a surgical technique known as power morcellation – a procedure to perform hysterectomies on women. The technique allows for an easier removal of a woman’s uterus than was ever previously possible. The device was introduced in 1993 and has become popular with doctors performing hysterectomies. The controversy over the procedure has only recently come to light following many morcellator lawsuits and many women are calling on the FDA to ban the devices.
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How Suspect Device Got Surgeon Group’s Blessing
Feb 17, 2015 | Wall Street Journal
By By Joseph Walker and Jennifer Levitz
Last May, as controversy mounted over a surgical device called the power morcellator, a professional association for surgeons issued a report defending the tool.
A month earlier, the U.S. Food and Drug Administration had warned the device risked spreading cancer in surgeries such as hysterectomies. But the May report, from the AAGL—formerly known as the American Association of Gynecologic Laparoscopists—said morcellation “remains safe when performed by experienced, high-volume surgeons.”
Doctors read the report closely for guidance on use of morcellators, which cut up and remove tissue through small incisions. What they didn’t know: An AAGL executive officer who received consulting fees from a morcellator maker had weighed in before publication.
The officer, New York surgeon Arnold Advincula, joined the AAGL board’s final discussions of the report, raising concerns among some in the group’s leadership, according to documents reviewed by The Wall Street Journal. That involvement violated conflict-of-interest policies, said Ceana Nezhat, the association’s president at the time, in a May 7 email to its executive director and medical director.
“Given the importance of COI surrounding this topic,” he wrote, referring to conflicts of interest, “and the potential press involvement in dissecting COIs of our board members in relation to morcellation, I am shocked the organization would allow their own policies to be ‘flexible.’ ”
In responses emailed through an AAGL spokeswoman, Dr. Advincula says he can’t comment on confidential board discussions. Dr. Nezhat declines to comment.
The AAGL spokeswoman says: “It is inevitable there is sometimes going to be conflicting and different points of view,” adding that AAGL ”should and does listen to all points of view before it reaches its formal position and guidance to our 7,500 members.” She declines to comment on internal documents.
The morcellator debate began in late 2013, when the Journal reported evidence that more women than previously thought have undetected cancer that morcellators can spread. Dozens of cases have emerged since then of women whose cancers quickly worsened after morcellation.
After its April 2014 warning, the FDA in November said doctors shouldn’t use morcellators on most women. Many hospitals have stopped using them. Johnson & Johnson , the largest maker, left the market.
In July, Andrew Brill, a former AAGL president, stepped down from an FDA panel evaluating the tools’ risks after the Journal disclosed he had done paid consulting for a morcellator maker. Dr. Brill didn’t respond to inquiries.
The AAGL had begun strengthening its conflict-of-interest provisions in 2013, when it adopted a policy forbidding executive-committee members from paid work for drug or device companies. Dr. Advincula and other incumbents on the committee were exempted under a grandfather clause Dr. Advincula lobbied for, say people familiar with the exemption.
Dr. Advincula, asked about the grandfather clause, says through the spokeswoman that board decisions “were the result of input from many board members.”
Dr. Advincula, chief of gynecological surgery at Columbia University Medical Center, has held leadership positions in the AAGL since 2012 and has been its president since December.
His 2014 disclosure on Columbia’s website reports he received at least $50,000 for speaking and other services in the prior 12 months from Blue Endo, a morcellator seller.
Dr. Advincula says through the spokeswoman that his consulting relates to sharing his clinical expertise and to collaborating with scientists and engineers. Blue Endo, of Lenexa, Kan., didn’t respond to inquiries.
AAGL’s conflict-of-interest policy played into the May 2014 report. In March, the association appointed a task force of 13 doctors to review scientific literature on morcellators and write a report with their findings and recommendations for how the tools should be used. The task force included only doctors with no financial ties to morcellator companies, the AAGL says.
The board held a May 6 conference call to discuss, edit and vote on the report the task force produced, documents viewed by the Journal show. Dr. Advincula, then vice president, had earlier urged AAGL to defend morcellators. “We need to be very decisive about where we stand and not be afraid to disagree with FDA if we believe mechanical powered morcellation has a place,” he emailed board members on April 18.
In the May call, Dr. Nezhat, who had financial ties with another morcellator maker, recused himself from discussing or voting on the report, according to conference minutes. Citing his authority as president under AAGL’s conflict-of-interest rules, he requested that Dr. Advincula not discuss the report because of his Blue Endo ties, the minutes show.
Dr. Advincula discussed the report but didn’t vote, according to the minutes, which don’t detail his comments. The board approved the report during the call.
The published report concluded that “all current methods of tissue extraction should remain available.” It also suggested doctors consider alternatives to morcellation in older women.
The report influenced how doctors viewed morcellators. Ricardo Estape, medical director of the Center for Robotic Surgery at Baptist Health South Florida, says he used it to help persuade hospital administrators to continue offering morcellation.
After concerns over the morcellator’s risks erupted, Baptist Health had wanted to stop using the tool, he says. “I said, ‘This is a group of physicians who do a lot of these procedures and they’re the ones you need to be listening to.’”
An official at Baptist Health says it convened experts to consider information from many sources and continues morcellation with steps including careful patient selection, informed consent and diagnostic steps.
After the May vote, Dr. Nezhat emailed AAGL’s board that the published report was misleading in stating that the board approved it with “no commercial, proprietary, or financial interest in the products or companies described in the report.”
“Unfortunately, Dr. Advincula did not recuse himself from the discussion and the minutes will reflect such, contrary to the statement released with the report,” he emailed the board May 9. “In hindsight, had we elected to follow zero tolerance regarding COI with no grandfather clause, as I suggested, we would not have this current problem.”
In a June email, Dr. Advincula told the board that during the May 6 call he encouraged the “board to spend time focusing on the conclusions but no input was made by me as to what the conclusions would be.”
The association today says morcellation with “appropriate informed consent should remain available to appropriately screened, low risk women.”
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Feb 16, 2015 | Wall Street Journal Blog
By Jennifer Levitz
The AAGL–formerly known as American Association of Gynecologic Laparoscopists–faces increased public attention because of the controversy over a device called the power morcellator. The Food and Drug Administration says the tool can spread hidden cancer, but AAGL has been a staunch defender of the device. AAGL, which trains doctors in tiny-incision surgeries, has historically had corporate partnerships. But it has also adopted new conflict-of-interest policies as the medical field has faced calls for more transparency. These policies have caused tension in the group’s leadership, The Wall Street Journal reports.
What is AAGL?
The AAGL is a medical society that promotes minimally invasive gynecologic surgery. Established in 1971, it has 7,500 members worldwide. It also issues position papers on the safety and effectiveness of procedures and techniques. The AAGL helps fund, with assistance from corporate grants, educational activities and fellowships in minimally invasive gynecology, according to its website.
What kind of influence do medical societies have?
Doctors rely on medical societies like the AAGL to provide unbiased advice on crucial issues affecting medicine–from patient safety to training guidelines. Insurers closely read the groups’ guidelines when deciding which procedures to cover. The public looks to medical societies to provide disinterested and unbiased advice.
What is the AAGL’s position on morcellation?
The AAGL has remained a vocal defender of the morcellator, which is used to cut up uterine fibroids or the uterus itself so the tissue can be removed through small incisions in minimally invasive procedures. The association today says morcellation with “appropriate informed consent should remain available to appropriately screened, low risk women.” The U.S. Food and Drug Administration has warned doctors against using the device, saying the tool risks spreading a hidden cancer in some women.
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Noorchashm on Morcellation, Patient Safety and Ethics
Feb 13, 2015 | YouTube
By Dr. Hooman Noorchashm
**Note: Dr. Hooman Noorchashm posted a video on his personal YouTube page of his lecture at Thomas Jefferson Medical College in Philadelphia, PA. The lecture focused on morcellation and the FDA's role in patient safety and ethics. The video of the lecture is available at https://www.youtube.com/watch?v=iI382zgwGOo **
Hooman Noorchashm MD, PhD presenting at a medical ethics lecture attended by Medical Student at theThomas Jefferson Medical College in Philadelphia, PA.
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Power Morcellators are Dangerous and Spread a Rare and Deadly Form of Cancer
Feb 13, 2015 | Lister Frost Injury Lawyers
Power morcellators are widely used as a minimally-invasive procedure in opposition to a surgical hysterectomy or myomectomy to remove the uterus laparascopically. The power morcellator is a small-bladed instrument that cuts the uterus into small pieces so that those pieces can be extracted. When the power morcellator cuts the uterus, it also cuts the sarcomas, thereby spreading the sarcomas to the abdominal cavity. Because no reliable method exists to distinguish a fibroid tumor from a sarcoma, the FDA has stated that 1 in 350 women have unsuspected and undiagnosed uterine sarcoma. Further, the FDA has estimated that the power morcellator spreads the cancer in up to 65% of the cases.
FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids… Procedure poses risk of spreading undetected cancerous tissue in women with unsuspected cancer
Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, 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.
(Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication, April 17, 2014)Approximately 25,000 Women Have Been Diagnosed With Leiomyosarcoma Following a Power Morcellator ProcedureThere have been medical conferences on the subject of mortality rates and power morcellators. Physicians are speaking out in opposition to their use because no clinical trials were done on the product, and now their patients who are diagnosed with leiomyosarcoma, stage 1, have a 60% life expectancy rate after 5 years; leiomyosarcoma, stage 3 have a 22% life expectancy rate and only a 15% life expectancy rate with a diagnosis of leiomyosarcoma, stage 4. The mortality rate outweighs the benefit of the minimally-invasive procedure.Johnson & Johnson Has Suspended Sales of Their Power Morcellator
There has been a significant amount of pressure put on morcellator manufacturers, both publicly by cancer victims and through warnings by the FDA to withdraw the power morcellator from the market. Johnson & Johnson, after the public bashing by victims, the stern warning by the FDA and also the filing of hundreds of cancer lawsuits, has withdrawn their power morcellator products from the market.
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Cancer Victim Files Morcellator Lawsuit Against Karl Storz
Feb 13, 2015 | Top Class Actions
By Ashley Vanover
A Michigan woman who was diagnosed with stage-4 bone and breast cancer has filed a lawsuit against Karl Storz Inc., the manufacturer of a power morcellator that allegedly spread cancer during her hysterectomy.
The power morcellator lawsuit was filed by Denise W. in the U.S. District Court for the Eastern District of Michigan on Jan. 26. The lawsuit alleges that thepower morcellator manufacturing company failed to provide adequate warnings to patients and doctors about the risk of cancer being spread during hysterectomy procedures using the Storz Rotocut G1 morcellator.
A Storz Rotocut G1 power morcellator was used in Denise’s surgery in June 2011, when she had a hysterectomy to treat uterine fibroids. The morcellator was used to slice up tissues in her uterus, making them easier to remove through small incisions in her abdomen.
In July 2014, while she was hospitalized for spinal surgery, doctors found late-stage cancer had metastasized in her body. The power morcellator lawsuit blames the spread of cancer on the morcellator.
Last year, the U.S. Food and Drug Administration (FDA) added a “Black Box” warning that morcellators can spread undiagnosed cancer, greatly worsening a patient’s prognosis. According to the morcellation lawsuit, Denise must now endure extensive medical treatments, including radiation therapy.
“As a result of the use of the Rotocut G1 power morcellator, Plaintiff developed Stage 4 bone and breast cancer, and has had to undergo extensive and intensive therapies for the treatment and management of her advanced-stage cancer,” the power morcellator lawsuit states. “This treatment includes daily hormone medications, regular injections of medications by her physicians and multiple ten-week rounds of radiation therapy.”
Power morcellators are medical devices used during laparoscopic hysterectomy and uterine surgery in order to reduce recovery time and limit the risk of surgical complications. However, serious concerns have emerged recently about the risk of power morcellation causing the spread of undiagnosed cancer cells contained within the uterus.FDA Warns Against Morcellation
The FDA’s announcement warns against morcellation based on data that suggests risks of spreading undetected cancerous tissue into areas outside of the uterus. According to the FDA, approximately one in 350 women who receive treatment for uterine fibroids have a rare form of cancer known as uterine sarcoma. There is no way to determine if a fibroid is cancerous before removal.
When power morcellation is used to treat women with undetected uterine sarcoma, there is a risk that cancerous tissue might spread. According to the FDA, this can significantly worsen chances of long-term survival.Power Morcellation Lawsuits
This morcellation cancer lawsuit joins thousands of similar complaints from women throughout the United States in recent years alleging that power morcellator manufacturers, like Karl Storz, failed to furnish sufficient warnings concerning the cancer risks to patients and doctors.
Power morcellators have been used in about 50,000 procedures each year. The FDA issued stronger warnings in December 2014 against the use of the devices after an advisory panel concluded that there was no safe way to use them, but has stopped short of banning them.
Denise is seeking compensation for her pain and suffering, medical and hospital expenses and punitive damages for Karl Storz’s alleged reckless disregard for public safety. The filed complaint indicates a demand for a jury trial for this case.
The Power Morcellation Lawsuit is Case No. 4:15-cv-10352-TGB-APP, in the U.S. District Court Southern for the Eastern District of Michigan.
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Morcellator Cancer Lawsuit Spreads
Feb 12, 2015 | Citizens Report
An increasing number of lawsuits are being filed against the manufactures of a device used in a surgical technique known as power morcellation – a procedure to perform hysterectomies on women. The technique allows for an easier removal of a woman’s uterus than was ever previously possible. The device was introduced in 1993 and has become popular with doctors performing hysterectomies. The controversy over the procedure has only recently come to light following many morcellator lawsuits and many women are calling on the FDA to ban the devices.
The main risk involved in using power morcellation to remove the uterus is the spread of leimysarcoma cancer, a highly aggressive form of cancer found in the uterus. This form of cancer has been known to spread to both the abdomen and pelvis. Numerous deaths have been attributed to leimyosarcoma cancer. It is often not tested for prior to performing the surgery and can lie dormant without symptoms before the morcellation is performed. Many women have claimed that they were never informed of the great risk that comes with the use of a Gynecare Morcellator. Because of this, Morcellation hysterectomy cancer lawsuits are on the rise.
Morecellation leimyosarcoma recently killed a women in New York two years after a power morecellation procedure was performed. On January 26, 2015, Dr. Amy Reed published a massive critique detailing the severe failings of the FDA in limiting the use of the power morcellation. Dr. Reed was diagnosed with leimyosarcoma cancer after receiving a hysterectomy in 2013. She worries that many lobbyists have prevented morecellator cancer lawsuits from receiving the public attention they deserve.
“Because these women were harmed by ‘life-saving devices'; bearing a seal of FDA authorization – and because their cancers were spread by our own doctors using an unsafe practice that is claimed to ‘benefit the majority’ – our federal government and its agency stands lethargic and ambivalent, ” said Dr. Reed in an article from Philly.com. This is a scary prospect for many women who could be having power morcellation surgery without being informed of the serious risks of morcellation cancer the procedure poses.
A team of Canadian researchers also published a study that found that power morcellation poses dire health risks for women receiving hysterectomies. Morcellated cancer lawsuits will continue to rise if these risks are not addressed. The Canadian study found that many women with leimyosarcoma cancer do not show any symptoms before the morcellator surgery is done. This lack of symptoms leads many doctors to operate without the knowledge that cancer could be spread. The study found that around one percent of women undergoing the surgery had leimyosarcoma cancer. This is a small number, but it differs greatly from the FDA’s current estimate. A large amount of these women later went on to file a leimyosarcoma lawsuit.
In November 2014, the FDA announced it would require doctors to give patients a warning about the use of power morcellators. They also issued a safety alert for women that may be undergoing power morcellator surgery. The number of morcellator cancer lawsuits continues to grow. Hopefully the FDA’s attempts and studies will reduce the number of cases of leimyosarcoma cancer and save lives. Many fear the FDA’s actions are not enough.Women Who’ve Suffered Power Morcellation Cancer Side Effects
Women who developed Uterine Cancer, Stomach Cancer or Leiomyosarcoma (LMS) after undergoing Fibroid Removal or a Hysterectomy may be eligible for legal compensation. Their lawsuits are against the power morcellator manufacturers for designing an instrument to be used in an unsafe manner.
Women who have had this cancer side effect are urged to consult with an attorney that has low fees and no risk. If you’ve been the victim, then Click here to receive your free case evaluation.
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