Preview Newsletter
Morcellation Media Monitoring 09/24/2015
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“Major postoperative complications” on the rise after morcellation's decline: Truth or false marketing?
Sep 22, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm and Amy J. Reed
A group of gynecologists led by Dr. J.A. Harris, at the University of Michigan recently published a paper about the impact of the FDA warning on post-operative complications following hysterectomy. In this paper the authors concluded that, “the rate of all major surgical complications or hospital re-operations did not change significantly after the date of the FDA communication”. They also concluded that “major surgical complications not including blood transfusions significantly increased after the date of the FDA safety communication, from 2.2% to 2.8% (p=0.015), and the rate of hospital readmission within 30 days also increased from 3.4% to 4.2% (p=0.025).” -
On Fear: Fourteen Ways of Looking at a Black Cat
Sep 24, 2015 | Curve
By Ellis Avery
A lesbian author discovers she has a rare form of cancer and, during treatment, considers getting a pet. -
FDA Morcellation Cancer Warning Prompts Change
Sep 22, 2015 | Top Class Actions
By Joanna Szabo
A Food and Drug Administration warning about the use of laparoscopic power morcellation to treat uterine fibroids led to widespread change about how the devices are used, where they are used and whether insurance will pay for a procedure using them. -
Power Morcellator Devices Under Investigation by GAO
Sep 24, 2015 | Top Class Actions
By Laura Schultz
The U.S. Government Accountability Office is currently investigating the FDA approval of power morcellators and their link to spreading undetected cancers when used during various gynecological surgeries such as hysterectomies and myomectomies. Recently 12 members of congress wrote a letter to the Government Accountability Office asking the agency to investigate power morcellators. -
Ethicon Gynecare Morcellex Lawsuit Filed Over Leiomyosarcoma Cancer Death
Sep 23, 2015 | AboutLawsuits.com
By Irvin Jackson
An Arkansas man has filed a wrongful death lawsuit against Johnson & Johnson and it’s Ethicon subsidiary, alleging that use of the company’s Gynecare Morcellex morcellator during a hysterectomy caused the spread leiomyosarcoma cancer throughout his wife’s body, leading to her death. The complaint (PDF) was filed by Larry Don Powell in the U.S. District Court for the Western District of Arkansas on September 21, over the 2014 death of his wife, Kimberly. -
Southern Med Law Files Two Morcellator Cancer Lawsuits Alleging Ethicon's Device Spread Uterine Cancer
Sep 23, 2015 | Press Release
By Southern Med Law
The power morcellator attorneys at Southern Med Law announce that they have filed two new morcellator cancer lawsuits against Johnson & Johnson's Ethicon, Inc. subsidiary. The power morcellator cancer complaints allege that the company's Gynecare Morcellex power morcellator device promoted the spread and upstaging of leiomyosarcoma uterine cancer when it was used to perform laparoscopic hysterectomies.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
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Sep 22, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm and Amy J. Reed
A group of gynecologists led by Dr. J.A. Harris, at the University of Michigan recently published a paper about the impact of the FDA warning on post-operative complications following hysterectomy. You can read the abstract of this study here.
In this paper the authors concluded that, “the rate of all major surgical complications or hospital re-operations did not change significantly after the date of the FDA communication”. They also concluded that “major surgical complications not including blood transfusions significantly increased after the date of the FDA safety communication, from 2.2% to 2.8% (p=0.015), and the rate of hospital readmission within 30 days also increased from 3.4% to 4.2% (p=0.025).”
In response, the University of Michigan Health System generated a press release stating that since the FDA warning, the incidence of "major postoperative complications" and 30-day hospital readmission rates has increased by up to "27%".
That sounds terribly scary to the casual reader.
You can read the press release from the University of Michigan, here.
The authors relate this seemingly troubling rise in complications to the recent inability of gynecologists to freely use a device known as a power morcellator. Specifically, in April and November 2014, the FDA warned that morcellation was placing up to one in 350 unsuspecting women at risk of having their deadly occult or missed cancers upstaged.
This incidence has recently been confirmed by multiple studies with a range of one in 156 to one in 500, depending on which hospital system or health insurance database is analyzed – this compared to the one in 10,000 incidence previously quoted to women with symptomatic fibroid tumors.
Morcellation was irreversibly damaging lives for over two decades - incredibly, unbeknownst to patients, to the general public or to the Food and Drug Administration. But many gynecologists and GYN specialty organizations knew of it and downplayed it all along.
You can read about this women’s health hazard caused by power morcellators, here. You can watch what morcellation actually is here.
In recent comments to the Philadelphia Inquirer, the Executive Vice President of the American College of Obstetrics and Gynecology (ACOG), Dr. Hal Lawrence, said that he wasn't "surprised" by the Michigan findings - because "it has been well documented that minimally invasive surgery decreases the complication rate, especially for patients with obesity, diabetes or renal failure. We had discussed this with the FDA". You can read the Inquirer article, here.
Dr. Lawrence continues to equate morcellation with "minimally invasive surgery". This is a serious conceptual error by a large number of gynecologists – because it directly translates into patient harm. The act of mincing up tumors inside patients’ abdominal cavities can spread malignant (as well as benign tissues) throughout the abdomen, causing severe and potentially deadly problems.
More than simply a conceptual error, we believe that the gynecological specialty’s attempt to equate morcellation with minimally invasive surgery is a deliberate oversimplification.
You can read a more extensive description of why the choice of words and rhetoric we use to describe problems in medicine matters, here.
So, while the complication and readmission rates may, not surprisingly, be on the rise since the decline of morcellation, we disagree with the gynecological surgeons’ suggestion as the root cause. The Michigan group and ACOG seem to be claiming that their inability to use power morcellators as freely as they did before increases complications simply because it limits their ability to do minimally invasive surgery.
We suggest an alternative explanation for this increase in complication rates: the gynecologists’ limited technical training in general surgical fundamentals. You can read our perspective about the systemic deficit in gynecological training here.
The bottom line is that, without morcellators, many of these surgeons and their support staff are likely to be finding themselves out of their "comfort zone".
We also find it interesting that in comments published in the Inquirer, the authors paradoxically state that their data "may not be statistically significant" regarding all major surgical complications or hospital reoperations!
And why would the authors, allow Michigan’s press office to quote an ominous sounding “27%” rise in complications – particularly when the press release is mostly directed at the lay public? Especially, when the authors are willing to admit that some results may be simply "due to chance".
This is a terrible misrepresentation, which we believe is false marketing.
Dr. Arnold P. Advincula, president of the American Association of Gynecological Laparoscopists (AAGL), seems to be equally inappropriate. In comments to the Inquirer, in one breath he stated that his own institution, Columbia University, no longer uses morcellation and has experienced no increase in complications. But, in another breath, he states that he is "unsurprised" by the Michigan conclusions - that is, assuming the results are not simply "due to chance". Why does Advincula even permit himself to say anything but, “there doesn’t seem to be much of a difference here” and “yes, morcellation has been upstaging cancers and devastating patients’ lives for over 20 years”?
The bottom line is that the Michigan press release is exaggerating a difference that may not even be a real difference – according to its lead author. We are left concluding, that this paper was written to create smoke and fog for the public in a pretty cut and dry scenario.
What we find truly unforgivable in this whole discourse, however, is the gynecological specialty and its leadership's near total inability to consider the ethics of what they have done – not a single gynecological leader has ever acknowledged that many precious women’s lives were robbed for over 20 years because of upstaged cancers.
This specialty appears unable to acknowledge that causing avoidable deadly harm to a minority subset of unsuspecting women with occult cancers of the uterus can never be ethically justified - no matter what the numbers are (one in 350 or one in 8,000).
The simple truth remains that the power morcellator serves as the most powerful contemporary example of professional, corporate and federal regulatory failures colluding to create a menace in women's health - leading to the premature or unnecessary loss of unsuspecting lives.
The battles waged, and lost, by Viviana Ruscitto, Martha Ariri, Brenda Leuzzi, Linda Interlichia and Barbara Leary (among many hundreds of others) attest to the facts for any person or institution with moral clarity.
Do read about these fallen victims with care here and here.
They will not be forgotten.
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On Fear: Fourteen Ways of Looking at a Black Cat
Sep 24, 2015 | Curve
By Ellis Avery
One morning seven years ago I woke up smiling. “I dreamed we had a little black cat named Fumiko,” I told my partner.
“Well, why don’t we have a little black cat named Fumiko?” came the reply.
The dream offered a note of sweetness during a difficult season: I’d spent years laid up with mysterious injuries no doctor could explain, and the latest ones—stress fractures in both feet that refused to heal—had proven especially debilitating. I was spending the winter in two surgical boots.
It was around this time, the beginning of 2009, that I was diagnosed with a rare autoimmune condition called reactive arthritis. Formerly known as Reiter’s syndrome, this disorder can cause crippling inflammation in the joints, blinding inflammation in the eyes, and burning inflammation in the urinary tract. The medical school mnemonic for this type of arthritis, which afflicts no more than 200,000 Americans a year, or .06 percent of the population, is “Can’t see, can’t pee, can’t climb a tree.”
A combination of two immunosuppressants healed my feet within eight months: methotrexate, which in higher doses is a chemo drug, and Humira, one of the most profitable drugs in the history of medicine, which is what’s called a tumor necrosis factor (TNF) blocker. By August 2009, after years stuck indoors, I could take a walk for pleasure. I could stand at a party again, and even dance. I threw away my surgical boots. To keep the arthritis at bay, I had to give myself six shots a month and keep the TNF blocker refrigerated: a small price to pay for the ability to walk.
Unbeknownst to me, in 2009 the FDA released a warning that there had been an increase in a rare cancer called leiomyosarcoma among juvenile and adolescent patients taking TNF blockers like mine. A cancer of the smooth muscle tissues, leiomyosarcoma affects approximately 2,000 Americans a year, just .0006 percent of the population. The onset of cancer, the FDA warning explained, typically occurred within 30 months of beginning use of the medication.
In January 2012, six months after my mother’s death and 35 months after I started taking TNF blockers, I began bleeding more heavily every month and finding drops of pee in my underwear: Both symptoms indicated the presence of a very large uterine fibroid. In April I had surgery for a fibroid the size of a small watermelon, a mass so big the doctor decided to “morcellate” it, removing it in pieces rather than all at once.
One in a thousand fibroid surgeries reveals the fibroid to be, as mine was, malignant. Two pathology reports and three oncological consultations later, it was official: I was diagnosed with uterine leiomyosarcoma. During the hysterectomy that followed the cancer diagnosis, the surgeon discovered that a tumor-crumb left over from the morcellation procedure had implanted itself outside my uterus, on the outer wall of my colon. According to a nomogram drafted by the leading specialists in leiomyosarcoma, taking into consideration my age, the size of the tumor, how quickly its cells divided, and the implanted tumor-crumb, I had a 26 percent chance of being alive in five years. I brought up the 26 percent figure when I met my oncologist, whom I’ll call Dr. Martha Hindsley, one of the authors of the leiomyosarcomanomogram. “If I do radiation or chemo, will this number be higher?”
“No,” she said. “There’s no data to say that radiation or chemotherapy can increase survival rate or prevent recurrence.”
Nonetheless, Dr. Hindsley offered a menu that included both radiation, which she recommended right away, and chemotherapy, which she encouraged me to save for later.
“If neither of these therapies have been proven to increase life expectancy or prevent recurrence, why do them?” I asked.
“Based on my experience, it’s better to do something than nothing.”
“But I am doing something,” I argued. “I’m doing five things. I’m not taking Humira or methotrexate anymore. I’m not producing estrogen the way I did when I had my ovaries. I’m eating a squeaky-clean diet. And maybe this sounds far-fetched, but I’m not mourning my mother anymore. The tumor seems to have started growing not long after she died last year.”
Dr. Hindsley smiled thinly. As far as she was concerned, none of those things constitutedsomething. “Why don’t you make an appointment with the radiation oncologist?”
I had read her work on leiomyosarcoma. I stood my ground. “But I thought you said in an article that in cases like mine, observation was the standard of care.”
“I said that observation was the standard of care for people with tumor contained completely inside the uterus whose tumors are removed intact,” Dr. Hindsley said, correcting me. I had never heard anyone use the word tumor without an a or the before. “You had a morcellation procedure and then an implant outside the uterus. I’d say your tumor has already declared itself. I’m recommending you make an appointment with a radiation oncologist because you’re probably 100 percent likely to have a big recurrence in your pelvis.”
I made the appointment. I spoke to people who had experienced pelvic radiation. I also got a second opinion.
“I wouldn’t say you’re 100 percent likely to have a recurrence in your pelvis,” said the second oncologist. “There’s a not-negligible chance you’ll have a recurrence.” She recommended chemo instead of radiation, explaining that although the side effects of chemo are brutal, the body clears out the drugs eventually, but irradiated tissue never goes back to its original state.
While neither oncologist recommended observation, the second one granted that “Not only is observation your right as a patient, it’s also a medically appropriate choice, given that, as you know,” she said, echoing Dr. Hindsley, “none of the options have been proven to increase life expectancy or prevent recurrence or metastasis.”
Recurrence is local; metastasis is distant: Both are words describing the cancer coming back. But if the disease recurs in my pelvis, there’s still a chance of a surgical cure, albeit one possibly involving a colostomy bag. If it metastasizes someplace else, like my lungs or brain or bones, then, as Dr. Hindsley said mildly, “You will probably die of your disease.”
Walking around my neighborhood that June, I felt my future slam shut, as implacable as a shopkeeper’s gate. I could not face the novel I’d been writing. I told the university where I taught that I wouldn’t be available to work in the fall. My partner and I had been slated to spend the following spring teaching in Paris, but I might have to be in treatment then: We cancelled our plans.
Amid the grim, clotted hours of appointments, phone calls, and online medical research, it occurred to us that, for the first time in years, with no travel plans on the horizon, we could toy with the idea of getting a pet. My partner began to wonder aloud, “Should we just get a cat now? I mean, what’s stopping us?”
“There are dozens of cute black shelter cats on Petfinders.com,” I said helpfully.
“So this is what you’re into behind my back! Pet porn!”
Two weeks of fostering later, it was official: We signed the adoption papers, and a little black cat named Fumiko entered our lives.
As Fumiko began to explore my apartment, I thought about radiation. I did not want to alienate my oncologist, one of the world experts on leiomyosarcoma. But I read and reread the handful of dense articles that have been published on LMS and memorized the bleak statistics. According to the only randomized study on patients with this cancer, getting radiation would decrease the chances of recurrence in my pelvis by only 4 percent, while it might even increase the chance of a metastasis to the lungs. That just didn’t sound good enough, given what I’d be getting for my 4 percent. Extreme fatigue. A permanently changed digestive tract. Damage to the irradiated organs. It’s true, most people who get radiation don’t wind up with a colostomy bag, but then again, most people who take my arthritis drugs don’t get cancer.
And meanwhile, I just kept wondering. Beyond the FDA warning, I couldn’t find any data, not even anecdotal data, on what happened to patients who got this cancer after taking tumor necrosis factor blockers. But not only had I been suppressing my immune system, I had also been taking a drug that specifically blocked my body’s ability to kill tumors. When my arthritic body thought my feet were tumors, that was a good thing, but then when I had an actual tumor to contend with, no one showed up to work. I had still been on the arthritis drugs when the morcellated tumor-crumb sank its roots into my colon wall. If I simply went off the drugs, could my immune system lick this cancer on its own? My tumor had already declared itself, in Dr. Hindsley’s words. But my drug-free immune system hadn’t yet declared itself. From what I understood about cancer—and after all the research I had done, I now understood a fair amount about cancer—we are all constantly generating and killing cancer cells. I doubted my body could kill large visible chunks of tumor on its own, but on a microscopic level? I’d never know if I didn’t try.=
I knew I could die from the consequences of my experiment. But I could suffer the side effects of radiation or chemo and die anyway.
Three anxious, research-filled weeks after Dr. Hindsley recommended radiation, I called her. “I have so much respect for you, and I’m so grateful that you’re my oncologist. But I’ve thought about this long and hard, and I’d like to defer treatment until we get the results of the next scan.”
“That’s wonderful that you’ve come to a decision you feel comfortable with,” she said crisply. “Let’s hope you have good news in October.”
I think I’d been expecting her to argue, to tell me I was making a mistake, to wag a witchy finger, howling, “Mark my words!” But she didn’t. The phone call took less than two minutes. That night, so relieved to have the conversation over, I slept like a baby.
And then the fear began.
Not long after I told Dr. Hindsley I wanted to defer treatment, I began to imagine what would happen if my next CT scan weren’t clear. The scan would be on a Monday. Dr. Hindsley had told me that the next day, Tuesday, she would call with the results, good or bad. The phone would ring, I began to imagine, and she would tell me the bad news. There’s something that looks like it could be tumor here in your pelvis, or in your abdomen, or it’s spread to your lungs.
Can we do surgery? I would ask Dr. Hindsley. If the tumor reappeared in the same spot as before, I’d tell her, Let’s sign me up for radiation as soon after surgery as possible.
Or Dr. Hindsley would say there’d been a metastasis, and I’d ask for chemo. This was what I imagined again and again: Dr. Hindsley calls to say there’s a tumor on the scan, and I tell her,You were right and I was wrong. Going off the arthritis drugs wasn’t enough. We tried my way, and it didn’t work. Now let’s fight this your way.
At first this imagined phone call, what I began to call the fear video, didn’t feel like what it was: an obsessive, fearful fantasy. It felt like a plan I was making, a problem I had to solve: What will you say if the doctor tells you there’s a tumor on the scan? I didn’t notice that it always ended the same way, and that it always made me feel worse.
“I guess you’ll be living from scan to scan,” my sister Amanda said, after reading up on leiomyosarcoma.
“Yes and no,” I said. “If I’m right and the medication caused the cancer, then if the first scan after I stop the drugs is clear, the next one will probably be clear, too. And if I have two years with clear scans, I’m probably out of the woods. What we don’tknow is this: Will the first scan be clear? Was stopping the drugs enough?”
“Yeah,” my sister said quietly. We hadn’t spoken regularly in years, but since the cancer diagnosis, she’d been calling every week. Fumiko the cat, shy at first, had become affectionate, and was curled in the curve of my hip as I spoke on the phone. “Are you scared?” Amanda asked.
“All the time,” I said.
Suddenly, I could hear Amanda’s dogs start to howl through the receiver, so loudly that the cat looked up at the telephone, alarmed, and flattened her ears. “Someone’s setting off fireworks,” my sister explained.
Fumiko gazed up at me with wide green eyes and settled as I stroked her satiny fur. I described her to my sister. “I love it that she follows us around. It’s like she’s our electron and all the places we might find her are her little probability clouds.”
“A Fumiko halo,” my sister said.
“Sometimes I love her so much I just want to squeeze her.”
“I feel the same way about my littlest dog,” my sister said. “I just hold her sometimes and tell her, ‘You are my ray of sunshine.’”
“Why was our mother so down on pets?” I wondered aloud.
“Her loss, man,” my sister said.
I could picture our mother now, face wreathed in cigarette smoke, half-melted chips of ice in a tall glass by her side. “Having a pet is like having a two-year-old,” she was declaiming as she hauled herself up to refill her glass. I could hear the smooth pour of bourbon. The pop of ice. For a moment, I was Fumiko, and my ears were flattening against my head. “A two-year-old who never grows up,” my mother was concluding as she collapsed back into the couch. She was lighting another cigarette, eyes fluttering closed on the deep inhale. She already had all the halo she needed, I realized.
“I’m scared too,” my sister said.
Cancer meta-researcher David Servan-Schreiber was a neuroscientist who, after accidentally discovering he had a brain tumor, made it his life’s work to gather together all the medical research available on things patients can do to fight their cancers. In so doing, he managed to keep his own cancer at bay for 20 years longer than anyone expected.
When I read Servan-Schreiber’s book, Anticancer, I oddly found it easiest to adopt his more punishing recommendations. Making myself walk two miles a day and switching to a sugar-free, flour-free, dairy-free diet wasn’t fun, but it came to me more easily than joining a support group or meditating. But because I pushed myself to do everything Servan-Schreiber recommended, I began attending the free daily meditation sessions offered at a yoga center up the street.
When your mind wanders, books on meditation counsel, try naming what your brain is doing and gently shepherding your attention back to the present. The idea is to get your observing mind to describe your attention, to just sit there and name your mental activity. “Feeling hot. Feeling uncomfortable. Nose itching. Butt itching. Bored. Making a grocery list. Nursing a grudge. Planning. Planning. Remembering. Remembering. Fantasizing about the past. Fantasizing about the future.” And so forth. While following these instructions, I discovered that I went back to the fear video, that imagined phone conversation with Dr. Hindsley, more often than I’d even realized.
Naming the fear video and observing when I played it in my mind felt like accomplishments all by themselves. Soon I realized I was playing the fear video in the shower every single morning. Naked, I found it all too easy to remember I had cancer: I saw my belly, flattening under a sugarless anticancer diet. I saw my long pink surgical scar: a tumor the size of a small watermelon, I remembered the surgeon saying. Cancer, tumor—it was an effortless glide into the fear video. Day after day, I’d get into the shower groggy and come out terrified.
Don’t be afraid, I told myself, trying to press the STOP button when the video began to play. It didn’t work. Nor did reminding myself that going off the arthritis drugs might be enough to keep the cancer at bay.
I couldn’t stop the fear video, but could I pause it? I began singing a long song that required my full attention just before I got into the shower: Tom Lehrer’s version of the periodic table of the elements set to the tune of “I Am the Very Model of a Modern Major-General.”I may have simply been indulging in cheery denial, but the choice to sing felt cannier than that, more like a conscious refusal to slide into the pit of dread: There’s antimony, arsenic, aluminum, seLEENium, hydrogen and oxygen, nitrogen and RHEENium…
One day not long after I began singing in the shower, when I stepped out of the tub, I looked up. There, on top of a door barely two inches thick, stood Fumiko, a black cat silently balancing on a thin strip of wood, eight feet above the ground. “What are you doing up there?” I asked. I sat down on the bed in my towel, and she took a swooping leap toward me. I was so delighted by her daring that for a moment I forgot I had cancer.
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FDA Morcellation Cancer Warning Prompts Change
Sep 22, 2015 | Top Class Actions
By Joanna Szabo
A Food and Drug Administration warning about the use of laparoscopic power morcellation to treat uterine fibroids led to widespread change about how the devices are used, where they are used and whether insurance will pay for a procedure using them.
According to the FDA,power morcellation could potentially spread undetected uterine sarcomas during myomectomies and hysterectomies.
Power morcellation was approved in 1991 to grind up and remove uterine fibroids, or benign tumors within the uterus. Power morcellators use extremely small incisions, which helps patients to recover more quickly and easily.
In the process of removing a structure such as fibroids, a power morcellator can cut up tissue fragments that, unknown to the doctor, are cancerous. These tissue fragments, once cut, are left behind as the fibroid or other structure is removed, and can spread from there to other parts of the body.
In its warning, the FDA estimated that approximately 1 in 352 women who undergo either a hysterectomy or myomectomy for uterine fibroid removal has an unsuspected uterine cancer.
The FDA also estimated that 1 in 498 women undergoing such surgeries has unsuspected leiomyosarcoma. Power morcellation could potentially distribute miniscule pieces of fibroids, which in some cases could be cancerous, throughout the body.
The FDA’s guidance advised companies that manufacture laparoscopic power morcellators to include a warning about the potential risks of cancerous uterine tissue, which could be disseminated throughout pelvic and abdominal cavities during morcellation.
Shortly after the FDA gave its warning, pharmaceutical and medical device manufacturing giant Johnson & Johnson removed its products from the market. Johnson & Johnson was a leading manufacturer of power morcellators.
Some large institutions stopped performing laparoscopic power morcellation altogether. Some health insurance companies no longer cover the cost of hysterectomies that include power morcellation.
While the FDA did recommend a black box warning about power morcellation’s risks and association with potential morcellation cancer, the federal agency did not ban the procedure entirely.
This has resulted in many companies investigating alternative methods of performing power morcellation. The goal for these companies is to maintain the minimally invasive surgery of the power morcellator without the increased cancer and mortality risk.
Medical experts are calling for informed consent from patients about the risks of power morcellation, or alternative procedures going forward.
Many patients have reacted to the warnings from the FDA as well, and have chosen to file power morcellation cancer lawsuits. These lawsuits claim that, had the plaintiffs involved known of the potential risk of cancer, they would not have consented to a power morcellation tool being used on them during surgery.
If you have undergone a surgery involving a power morcellator and have since been diagnosed with cancer, you may be able to file a power morcellation cancer lawsuit.
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Power Morcellator Devices Under Investigation by GAO
Sep 24, 2015 | Top Class Actions
By Laura Schultz
The U.S. Government Accountability Office is currently investigating the FDA approval of power morcellators and their link to spreading undetected cancers when used during various gynecological surgeries such as hysterectomies and myomectomies.
Recently 12 members of congress wrote a letter to the Government Accountability Office asking the agency to investigate power morcellators.
The congressmen and women who signed the letter include representatives from Pennsylvania, New York, Louisiana, California, Connecticut, Illinois, Washington and several other states.
The lawmakers are asking the GAO to consider whether medical device reporting regulations were appropriately followed by the device manufacturers and the FDA, specifically whether federal regulations associated with FDA approval policies sufficiently identify risks of adverse events; and what steps the FDA is now taking to determine whether laparoscopic power morcellators are safe to remain on the market.
The investigation by the GAO comes shortly after the Federal Bureau of Investigation probed into whether Johnson & Johnson, one of the medical device manufacturers, had prior knowledge of the dangers of power morcellators use in gynecological surgeries.
Whether or not an FBI investigation has been initiated is currently unconfirmed.
What are Power Morcellators?
Power morcellators are a type of laparoscopic medical device used by surgeons. Many patients choose to use power morcellators because they allow surgical procedures to be performed in a minimally invasive way.
Laparoscopic surgeries are generally associated with a reduced risk of infection and a shorter recovery time. Unfortunately for many women, the use of power morcellators during gynecological surgeries may cause the spread of aggressive cancer cells.
FDA Power Morcellator Warnings
The U.S. Food and Drug Administration started warning medical professionals and women who are considering gynecological surgeries to avoid the use of power morcellators.
According to the FDA, 1 out of 350 women who undergo a hysterectomy or myomectomy have an undiscovered uterine sarcoma, a type of uterine cancer.
For many patients, at the time of the surgery the cancer cells are in their beginning stages and self contained. Then the power morcellator shreds the tissue in the woman’s uterus causing the cancerous cells to spread throughout the body and exponentially fast rate.
Morcellation Lawsuits
Product liability attorneys are currently looking for potential plaintiffs to bring power morcellator lawsuits against the medical device manufacturers for failing to warn consumers about the dangerous risks associated with these devices.
Potential morcellator plaintiffs include women who were diagnosed with cancer within two years of having gynecological surgery. Gynecological surgeries include myomectomy (removal of fibroids), oophorectomy (removal of ovaries), salpigectomy (removal of the fallopian tubes), and a hysterectomy (the removal of the uterus).
Power morcellator lawsuits may provide successful plaintiffs with compensation to pay for both past and future medical bills and can serve as a small step towards compensating victims for the pain and suffering they have endured due to the medical device.
In some cases, morcellation lawsuits may be brought by family members who have lost loved ones to cancer spread by power morcellators. This is known as a wrongful death lawsuit.
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Ethicon Gynecare Morcellex Lawsuit Filed Over Leiomyosarcoma Cancer Death
Sep 23, 2015 | AboutLawsuits.com
By Irvin Jackson
An Arkansas man has filed a wrongful death lawsuit against Johnson & Johnson and it’s Ethicon subsidiary, alleging that use of the company’s Gynecare Morcellex morcellator during a hysterectomy caused the spread leiomyosarcoma cancer throughout his wife’s body, leading to her death.
The complaint (PDF) was filed by Larry Don Powell in the U.S. District Court for the Western District of Arkansas on September 21, over the 2014 death of his wife, Kimberly.
The Gynecare Morcellex is a type of morcellator used during minimally invasive hysterectomies, allowing doctors to cut up and remove the uterus and uterine fibroids through a small incision in the abdomen. However, the device has been linked to a risk of spreading undiagnosed cancer cells that may be hidden within the uterus, rapidly upstaging aggressive cancerns like leiomyosarcoma.
Kimberly Powell underwent a robotic hysterectomy with morcellation in June 2011. It was only after the surgery that it was discovered that leiomyosarcoma cancer cells were in the shredded tissue, which was spread throughout her body cavity. As a result, the uterine cancer was rapidly upstaged, ultimately resulting in her death less than three years later.
“The leiomyosarcoma cancer tissue in Mrs. Powell would have remained encapsulated bur for the tissue shredding and tissue dissemination of the Gynecare Morcellex,” the lawsuit states. “The device, in cutting and shredding the uterine fibroid, ruptured the capsule containing the cancerous tissue and spread the shredded tissue in Mrs. Powell’s abdominal cavity. That action changed the course and prognosis of the leiomyosarcoma cancer which had been encapsulated, upstaging it and profoundly injuring the patient, leading to her death.”
Powell’s complaint joins a growing number of other power morcellator lawsuits filed against Ethicon and other manufacturers of similar devices used during laparoscopic or robotic hysterectomy procedures. The lawsuits allege that the manufacturers failed to adequately warn about the risk of undiagnosed uterine cancer being spread by morcellation.
Power Morcellator Cancer Litigation
While use of morcellators during minimally invasive hysterectomies has increased in popularity over the past decade, the devices have largely been abandoned in recent years, after doctors learned about the risk of spreading leiomyosarcoma, endometrial stromal sarcoma and other uterine cancers.
Recent estimates suggest that about one out of every 350 women undergoing surgery for symptomatic uterine fibroids may have unsuspected sarcoma contained within their uterus. For these women, power morcellation may disseminate the contained cancer throughout the body, rapidly advancing the leiomyosarcoma or other cancers to a very advanced stage.
The litigation over power morcellators has emerged since the FDA issued warnings about the risks associated with the device in April 2014, where the agency urged doctors to avoid performing the popular, minimally invasive uterine surgery, which an estimated 50,000 women per year have undergone over the past decade.
While the FDA has allowed laparoscopic morcellators to remain on the market, with much stronger warnings about the potential cancer risks, many hospitals have announced that they will no longer perform hysterectomy or uterine fibroid removal procedures with morcellation, indicating that there is no way to justify the risk.
In June, a group of plaintiffs involved in the litigation filed a motion to centralize the power morcellator litigation before one judge in the federal court system, as part of an MDL or multidistrict litigation.
A number of different manufacturers have opposed centralization of the power morcellator cancer lawsuits, arguing that there are too few cases and too many different products involved to justify establishing an MDL.
Johnson & Johnson’s Ethicon unit, which previously sold the majority of morcellators on the market, under the Gynecare Morcellex brand, has also urged the panel to reject the possibility of establishing separate MDLs for each different manufacturer. However, the company removed all Gynecare morcellators from the market in the summer of 2014, indicating that they saw no way to make them safe for women.
The U.S. Judicial Panel on Multidistrict Litigation will hear oral arguments on consolidation at an October 1 hearing.
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Sep 23, 2015 | Press Release
By Southern Med Law
The power morcellator attorneys at Southern Med Law announce that they have filed two new morcellator cancer lawsuits against Johnson & Johnson's Ethicon, Inc. subsidiary. The power morcellator cancer complaints allege that the company's Gynecare Morcellex power morcellator device promoted the spread and upstaging of leiomyosarcoma uterine cancer when it was used to perform laparoscopic hysterectomies.
Power morcellators are surgical tools that to shred, cut and remove uterine tissue and fibroids during minimally-invasive gynecological surgeries. According to a morcellator lawsuit filed in the U.S. District Court, Eastern District of Washington, by Southern Med Law on September 18th, the Gynecare Morcellex device was used in the removal of large uterine fibroids when the Plaintiff underwent a laparoscopic supracervical hysterectomy in December 2012. It was later discovered that leiomyosarcoma cancer was present in her uterine tissue at the time of her surgery. (Case 2:15-cv-00252)
The second lawsuit was filed in the U.S. District Court, Western District of Arkansas, on September 21st on behalf of a widower who lost his spouse to leiomyosarcoma in March 2014. According to his complaint, the Plaintiff's wife had undergone a robotic laparoscopically-assisted hysterectomy and cystoscopy in June 2011, at which time the Gynecare Morcellex device was used to cut, shred and remove much of her uterus. Following the surgery, leiomyosarcoma was discovered to be present in the tissue shredded by the morcellator. (Case 6:15-cv-06100-SOH)
Both morcellator cancer lawsuits allege that leiomyosarcoma cancer tissue present in the women would have remained encapsulated but for the tissue shredding and dissemination caused by the Gynecare Morcellex morcellator. The device ruptured the capsule containing the cancerous tissue and spread the tissue into their abdominal cavities. According to the morcellator cancer lawsuits, that laparoscopic morcellator surgery changed the course and prognosis of the leiomyosarcoma cancer, upstaging it and profoundly injuring the patients, leading to their physical and economic damages.
Power Morcellators And Uterine Cancer
Since April 2014, the U.S. Food & Drug Administration (FDA) has published two morcellator cancer warnings, the first of which discouraged doctors from using the devices due to their potential to disseminate dangerous uterine malignancies. In November 2014, the FDA ordered that a new black box warning be added to the labeling of power morcellators regarding the risk that the devices will spread uterine sarcoma and other cancer cells if they are present at the time of surgery. The agency also cautioned against the use of power morcellators in the majority of women who require myomectomy and hysterectomy. The FDA has estimated that 1 in 352 women with fibroids actually have undiagnosed uterine sarcoma, while 1 in 498 has the more aggressive form of the disease, leiomyosarcoma.
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm, April 17, 2014]
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm, November 24, 2014]
Southern Med Law has been fighting for the rights of alleged morcellator cancer victims even before the FDA acted to warn the public about this potential danger. Among other things, Dr. François Blaudeau, the Firm's founder, serves as Lead Counsel in what was the first power morcellator cancer lawsuit filed in a U.S. court. The case, which was scheduled to go to trial this November in the U.S. District Court, Eastern District of Pennsylvania, was recently settled for an undisclosed amount. (Case No. 5:14-cv-1557, E.D. Pa., Allentown)
As both an attorney and practicing obstetrician/ gynecologist, Dr. Blaudeau's understanding of female reproductive issues, together with his knowledge of the law, allows him to approach power morcellator cancer lawsuits with a unique perspective. If your life has been devastated because of uterine cancer that was allegedly disseminated and upstaged via a power morcellator, please contact Southern Med Law today to learn more about your legal rights. You can arrange for a free, no obligation power morcellator cancer lawsuit review by visiting www.southernmedlaw.com, or by calling the office directly at 205-547-5525.
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