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Morcellation Media Monitoring 11/19/2015
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J&J Says There Were No Reportable Morcellation Events; Whistleblower Disagrees—and Produces Letters
Nov 18, 2015 | The Cancer Letter
By Matthew Bin Han Ong
Johnson & Johnson officials said the company was unaware of any reportable adverse events resulting from the use of power morcellators prior to 2013. “[J&J subsidiary] Ethicon was not aware of any reportable events related to morcellators and the possibility of upstaged cancer prior to December 2013,” a company spokesman said to The Cancer Letter. “Since that time, we have filed reports with the FDA for all reportable events that have come to our attention.” -
FDA: Federal Law Requires Reporting of Morcellation Adverse Events, But None Were Brought to Agency’s Attention For 8 Years
Nov 18, 2015 | The Cancer Letter
FDA officials said the agency didn’t receive any reports of adverse outcomes resulting from power morcellation prior to December 2013. “Of note, prior to December, the FDA had received no MDRs specifically on cancer and upstaging/dissemination,” the agency said in response to questions from The Cancer Letter. “Since then, the agency has become aware of about two dozen that have discussed ‘cancer’ and ‘upstaging or dissemination’ as of November 2014. All of these reports pertained to procedures that took place prior to December 2013.” -
Power Morcellation OK for Younger Patients, Study Suggests
Nov 17, 2015 | Top Class Actions
By Paul Tassin
A new study suggests that power morcellation might still be a reasonably safe method of uterine fibroid surgery, but only for younger patients. The study addresses the risk that using power morcellation for hysterectomy or uterine fibroid surgery may inadvertently spread cancer that went undetected prior to the surgery. -
Power Morcellator Lawsuit Alleges Tool Contributed To Death Of LA Woman
Nov 19, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a wrongful death lawsuit which has been filed against laparoscopic power morcellator manufacturer Ethicon, (a subsidiary of Johnson & Johnson). The lawsuit was filed in Los Angeles, California by the family of a woman who has passed away due to uterine cancer which they allege was spread and upstaged by the morcellator during a surgery to remove painful uterine fibroids. -
Power Morcellator Lawsuit Surge Spurs Congress Letter To G.A.O.
Nov 17, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on details first announced by the Wall Street Journal, indicating that twelve members of Congress had issued a letter to the United States Government Accountability Office in August which requested that the agency investigate laparoscopic power morcellators. The device has been surrounded by much recent controversy as mounting lawsuits allege that it can spread uterine cancer in women undergoing gynecological surgeries, such as hysterectomies and myomectomies. -
Power Morcellator Lawsuit Claims Tool Caused Upstaged, Aggressive Cancer
Nov 17, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports today on another lawsuit which has been filed against Gyrus Acmi LP, regarding the power morcellator tool they manufacture. This suit joins many others filed against various power morcellator manufacturers from across the nation in the current multidistrict litigation. In this filed complaint, the plaintiff alleges that the morcellator device used for her gynecological surgery exposed and spread cancer cells throughout her body, even outside of the uterine walls. Details in the complaint indicate that post-surgery, the woman was suddenly diagnosed with widespread and upstaged cancer. She alleges that she has been told the cancer will greatly reduce her possibility of survival.
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Full Text of Stories Below
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J&J Says There Were No Reportable Morcellation Events; Whistleblower Disagrees—and Produces Letters
Nov 18, 2015 | The Cancer Letter
By Matthew Bin Han Ong
Johnson & Johnson officials said the company was unaware of any reportable adverse events resulting from the use of power morcellators prior to 2013.
“[J&J subsidiary] Ethicon was not aware of any reportable events related to morcellators and the possibility of upstaged cancer prior to December 2013,” a company spokesman said to The Cancer Letter. “Since that time, we have filed reports with the FDA for all reportable events that have come to our attention.”
Ethicon responded to The Cancer Letter’s questions after the Nov. 17 hearing by the Subcommittee on Health, where Rep. Tim Murphy (R-Pa.) noted that the company had received a report about the dangers of power morcellators.
FDA issued an advisory April 2014 discouraging the use of power morcellation, stating that one in 350 women who undergo hysterectomy or myomectomy for fibroids have an unsuspected uterine sarcoma.
J&J requested withdrawal of morcellators in July 2014, after an FDA panel expressed low confidence in the devices for use in hysterectomies and myomectomies (The Cancer Letter, July 25, 2014).
At the congressional hearing, Murphy said J&J was informed of similar estimates as early as 2006, when Robert Lamparter, a pathologist from central Pennsylvania, alerted J&J officials to the risk of the device spreading undetected uterine sarcoma.
“Dr. Lamparter did contact the company in 2006 seeking advice on ways to collect and evaluate endometrial specimens following morcellation,” Ethicon said in a statement to The Cancer Letter. “Because Dr. Lamparter did not report an actual experience with a patient, his communication was handled as a complaint, and was not reportable as an MDR.”
FDA officials said the agency didn’t receive any reports of adverse outcomes resulting from power morcellation prior to December 2013.
Lamparter, 64, a retired pathologist who practiced at Evangelical Community Hospital in Lewisburg, Pa., for 28 years, said that J&J is not telling the whole truth.
“Technically, they’re saying that I didn’t report it as a patient whose cancer was spread, so technically, they didn’t lie,” Lamparter said to The Cancer Letter. “But they’re implying that I didn’t tell them, and that’s not the truth.
“I’m sort of an accidental whistleblower. I didn’t go out with an ax to grind, but I do feel strongly that the company has tried to hide this from people, and I’m glad to see that somebody like Dr. Hooman Noorchashm is bringing this to the forefront.
“I think what they’re going to try to do in laying out a legal strategy is, ‘This didn’t meet the standards for a reportable event, so we’re clear,’” Lamparter said. “That’s how they are going to try to defend themselves.”
Lamparter’s 2006 correspondence with Ethicon is posted here.
"I Hope You Reconsider"
Lamparter said he first reported the issue as a “near-miss” case—a patient who was scheduled for power morcellation, but ultimately wasn’t subjected to the procedure.
“We had a patient who was saved by her guardian angel,” Lamparter said. “It was a situation where an operation was started as a morcellation. The doctor couldn’t do it as a laparoscopic surgery because of adhesions, so they elected to do it open. When they took the uterus out, there was a cancer there, and had they morcellated it, that cancer would’ve been spread.
“Now, we knew theoretically this was a possibility prior to this index case, but as we had this near-miss case, we felt that we had enough information that we could mention this to the company. It’s no longer a hypothetical—we had a near miss.”
Lamparter initially brought his concerns to David Robinson, the medical director of Ethicon Women’s Health and Urology at the time.
“My conversations with Ethicon started as, ‘How do we solve this problem? The way our gynecologists were using the device, we couldn’t find the endometrium to document the status of the inner lining of the uterus,’ Lamparter said. “That’s how the conversation began, and during that conversation, we had our near-miss case, and that gave me the opportunity to tell Dr. Robinson about it.”
Lamparter said he sent several emails to Robinson “until [Robinson] understood the significance of what I was telling.”
“We recently had a patient with an unexpected malignancy who almost had a morcellization [sic], save that she was saved from inappropriate morcellization by adhesions,” Lamparter wrote in a February 2006 email to Robinson. “We have had a good endometrial biopsy six months prior to the procedure. After we found a carcinoma in the endometrium after hysterectomy, we reviewed the endometrial biopsy and found no malignancy.
“If this woman had had a morcellization, her tumor would have been seeded into the peritoneum. We pathologists might not have even found it, until it had metastasized if she had a morcellization. Or, we might have documented benign endometrium, because that what’s was covering the majority of the endometrial cavity.
“At least one missed malignancy after morcellization has been reported in the literature: 1997 American Journal of Obstetrics and Gynecology, ‘Recurrence of unclassifiable uterine cancer after modified laparoscopic hysterectomy with morcellation by A. Schneider.”
Lamparter said Robinson forwarded his report to Ethicon’s World Wide Customer Quality Department. Ethicon classified Lamparter’s concerns as pertaining to an “off-label use.”
“I got a nonsensical letter back from Lori Pasternack, who was the representative of that committee,” Lamparter said. “That wasn’t my inquiry, about how to use it off label.
“They never really responded to why we couldn’t find the endometrium. By trial and error, we eventually did figure out what happened, and why that was—it was the technique our surgeons were using, which they apparently weren’t well taught at the training center on how to use this thing. Once we changed the technique, we began to find the endometrium.”
Ethicon reviewed the correspondence between Lamparter and Robinson and informed Lamparter that the company was ending the investigation.
“You reported to our Medical Director that you have experienced difficulty of examining the endometrium of uteri that have undergone morcellation by our morcellator device,” Ethicon’s Pasternack wrote in a May 2006 email to Lamparter. “Your concern is that you fear missing an endometrial cancer.
“The morcellator device is indicated to remove tissue, and it is not indicted [sic] for sample gathering or preparation. Therefore, your concern is in regards to an off-label use.”
Enclosed with Pasternack’s letter was a copy of Ethicon’s power morcellator user manual.
Lamparter replied, asking Ethicon to “reconsider” his report and inform the gynecology community of the risks.
“In about 1/300 hysterectomies at our hospital, we discover an endometrial carcinoma that was unexpected at the time of surgery,” Lamparter wrote. “To recommend to the gynecologist users that it important to evaluate the endometrium for cancer prior to performing morcellation is such a simple solution that I find it difficult to understand why Ethicon-Gynecare hasn’t made the recommendation.
“It doesn’t cost the company anything to make the recommendation, and it’s cheap insurance for all the involved parties. Trying to put myself in your shoes, the only reason I can see for the company’s stance is that others haven’t reported the problem yet.
“My speculation in that regard is that the literature hasn’t yet been written on this topic, so nobody knows to knock on your door at this time. Time will tell.
“If your letter to me was written in haste, I hope you reconsider.”
Lamparter said he did not receive a response.
Lamparter: I Don’t Think J&J Looked
Lamparter said J&J’s statement that the company was not “aware of…the possibility of upstaged cancer prior to December 2013” ignores his past correspondence with Ethicon.
“In that letter to Lori Pasternack, I pointed out this thing would seed tumor on the peritoneum and upstage the cancer,” Lamparter said. “They’ve had two opportunities to act—I told Dr. Robinson, and I told the person who is the representative of J&J’s World Wide Customer Quality counsel that they have a problem.
“If you have a cancer that is hidden in the uterus and it’s at a much lower stage and you seed that, it metastasizes and is considered to be a much higher stage. So they did know that this procedure could upstage the cancer. They knew that in 2006.
“I can understand that they would be skeptical of some local yokel in a community hospital telling this, but they could at least investigate and look over their shoulder and see that the statistics show risk way too high compared to what we think it is.
“I can understand their inclination to just give me a polite letter and blow me off, but you know, when somebody is telling you something like that, you should at least look. And I don’t think they looked, because if they had, they would’ve found it.
“In the beginning, I thought it was just a matter of educating the doctors to be more careful in patient selection. As time went on, it became apparent that it wouldn’t make any difference. They would still accidentally morcellate cancers in about one in 300 times.
“I’m not the only person who had a patient that had morcellated cancer. Over time, we had between four and seven patients with morcellated malignancies at our hospital.
“We were a 95-bed hospital, now, you multiply the number of hospitals with many more hospital beds—and more active gynecology services than we had—around the country.
“J&J had to have known, because there were other patients having problems.”
The full text of Ethicon’s statement follows:
First, we sympathize with the women and their families who may have suffered the spread of a malignancy following surgical treatment for gynecologic conditions, and continue to collaborate with the medical community in efforts to potentially reduce the risk in the future and to better enable physicians and patients to understand the risks and limitations ahead of their surgery.
As the medical community’s understanding of the risk of undiagnosed malignancies prior to uterine surgery evolved in 2014, we elected to suspend sales and then to voluntarily withdraw our powered morcellation devices from the marketplace. We remain the only manufacturer to have taken these steps.
Ethicon files Medical Device Reports (MDRs) on our products with the FDA in a timely manner once information is received or noticed by the company indicating that reporting is appropriate under FDA guidelines.
Ethicon was not aware of any reportable events related to morcellators and the possibility of upstaged cancer prior to December 2013. Since that time, we have filed reports with the FDA for all reportable events that have come to our attention, even when it was unclear whether one of our devices was involved.
We take our reporting responsibilities seriously, and have filed reports related to morcellation devices even when we were unable to confirm that the device used was manufactured by Ethicon.
Nearly all of the reports we have filed were not the result of reports made directly to Ethicon, but based on information from news articles and lawsuits following increased public attention to this issue beginning in the fall of 2013. Ethicon morcellation devices have always included cautions in their instructions for use (IFU) about the potential spread of cancerous tissue.
We highly value the feedback we receive from physicians and we are continually assessing the totality of the available data and information related to our products, including peer-reviewed studies and scientific literature, as well as physician feedback.
Dr. Lamparter did contact the company in 2006 seeking advice on ways to collect and evaluate endometrial specimens following morcellation. Because Dr. Lamparter did not report an actual experience with a patient, his communication was handled as a complaint, and was not reportable as an MDR.
His questions, along with other medical consultation at that time, prompted Ethicon to revise the precautions contained in the device’s IFU to address the issue of the preoperative pathologic evaluation of the endometrium to minimize the risk of inadvertent morcellation of an occult malignancy.
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Nov 18, 2015 | The Cancer Letter
FDA officials said the agency didn’t receive any reports of adverse outcomes resulting from power morcellation prior to December 2013.
“Of note, prior to December, the FDA had received no MDRs specifically on cancer and upstaging/dissemination,” the agency said in response to questions from The Cancer Letter. “Since then, the agency has become aware of about two dozen that have discussed ‘cancer’ and ‘upstaging or dissemination’ as of November 2014. All of these reports pertained to procedures that took place prior to December 2013.”
Robert Lamparter, a retired pathologist, alerted Ethicon, a Johnson & Johnson subsidiary, about potential problems with morcellators in 2006. The Pittsburgh Business Times reported on the whistleblower case in May 2014.
A full account of Lamparter’s 2006 complaint is published here.
According to an FDA advisory in April 2014, one in 350 women with undergoing hysterectomy for the treatment of is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.
Two women—Erica Kaitz and Amy Reed—underwent power morcellation performed at Brigham & Women’s Hospital in 2012 and 2013, respectively. Kaitz died on Dec. 7, 2013 from metastatic leiomyosarcoma, and Reed recently underwent surgery for a third recurrence (The Cancer Letter, Nov. 26, 2014, Nov. 3, 2015).
Responding to similar questions from Rep. Mike Fitzpatrick (R-Pa.), FDA said it disagrees with the 2011recommendations from the Institute of Medicine, which called for an overhaul of the agency’s 510(k) process for clearing devices (The Cancer Letter, July 4, 2014).
“The Institute of Medicine made eight recommendations to FDA, one of which was that FDA should design a new system for the review of Class II devices,” FDA wrote to Fitzpatrick. “While FDA does not agree with IOM’s recommendation to create a new system, we do believe that we can make improvements to the current system and we have worked to do so over the past four years.”
FDA responded to questions from Matthew Ong, a reporter with The Cancer Letter.
Matthew Ong: Knowing what we know now, should the power morcellator have gone through more rigorous testing before it was cleared for the market?
FDA: Having more rigorous testing of morcellators before clearance likely would not have addressed the issue of spreading unsuspected cancer through morcellation, because uterine sarcomas are a rare type of cancer; the rate of unsuspected uterine sarcoma in women undergoing hysterectomy or myomectomy for the treatment of uterine fibroids is about 1 in 350.
Even a large clinical trial involving hundreds of patients would have been unlikely to detect these events. After the risks of power morcellators spreading unsuspected cancer became known, the FDA took several steps to reduce the risk of spreading unsuspected cancer by laparoscopic power morcellation during fibroid surgery, including asking manufacturers to add a boxed warning to product labels specifying:
1) Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or are candidates for en bloc tissue removal, e.g. through the vagina or mini-laparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
2) Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
The contraindications cover a majority of women who would undergo morcellation during myomectomy or hysterectomy. This should help to reduce the use of the device in patients at greatest risk.
The FDA has also asked manufacturers to include the following boxed warning in their product labeling: Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
MO: Are there any lessons to be learned at FDA from the power morcellation case?
FDA: Any device cleared or approved for marketing carries a certain element of risk that must be weighed against potential benefits offered to patients. FDA believes there is an opportunity for manufacturers to develop products that may further reduce this risk of spreading existing cancer.
Better diagnostics aimed at detecting uterine cancer as well as containment systems designed specifically for gynecological surgery could be helpful. Experts from our July 2014 panel meeting agreed that innovation in these areas may further address this risk.
The FDA continues to actively work to strengthen its medical device post market surveillance system.
MO: Does FDA have any plans to tighten the medical device clearance process i.e. the 510(k) or to seek additional authority from Congress to do so?
FDA: The 510(k) program works well to determine whether new devices are substantially equivalent to a previously cleared device, meaning that the new device is as safe and effective as its predicate.
We’ve had tens of thousands of good products come on the market through that pathway, and it encourages manufacturers of lower risk devices to make important upgrades to enhance the performance of their device without having to go through the expense of a premarket approval.
FDA does acknowledge that the clearance process can be improved, and we remain open to opportunities to enhance the programs we have whether through a program reform, or if there are appropriate changes that can be made to the law, to new legislation.
MO: How would the 21st Century Cures Act—if passed in its current form—change regulation of medical devices at FDA?
FDA: FDA cannot predict how this legislation will affect device regulation in the future since it is still in transitory stage and has not yet been passed by both houses of Congress or signed into law.
MO: Is it true that manufacturers and user facilities—Johnson & Johnson/Ethicon and Brigham & Women’s Hospital—did not report adverse events resulting from power morcellation as per the Section 803 Title 21 mandate? Does FDA see a need to ensure that user facilities report in a more robust fashion?
FDA: Manufacturers, such as J&J/Ethicon, are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury.
Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office.
User facilities are required to report a suspected medical device-related death to the FDA and the manufacturer within 10 workdays of becoming aware of the event. They must report serious device-related injuries to the manufacturer and to the FDA if the manufacturer is unknown.
With regard to the spread of unsuspected cancer when using laparoscopic power morcellation for hysterectomy or myomectomy in women with symptomatic uterine fibroids, the FDA has clarified that it considers such an event to be reportable as a serious injury.
The FDA has generally focused its enforcement resources on manufacturers—who are required under law to investigate any MDR-reportable complaint they receive—and not on hospitals.
The FDA has found that encouraging more reporting—and more complete reporting—by hospitals/user facilities and physicians, is a good use of the limited resources in this area.
Of note, prior to December, the FDA had received no MDRs specifically on cancer and upstaging/dissemination. Since then, the agency has become aware of about two dozen that have discussed ‘cancer’ and ‘upstaging or dissemination’ as of November 2014. All of these reports pertained to procedures that took place prior to December 2013.
The timing of these reports may be due to the heightened sensitivity and media attention given to the subject in late 2013. The FDA is still analyzing the adverse event data it has received on morcellation.
MO: Is it true that some PMA-approved devices (and/or 510k-cleared devices) are exempt/excluded from civil/product liability litigation because FDA has approved them?
FDA: The FDA does not “exempt” devices from lawsuits. Rather, certain state requirements that apply to medical devices are preempted under section 521 of the Federal Food, Drug, and Cosmetic Act.
Interpreting this provision, the Supreme Court has said that state common law claims relating to approved class III devices generally are preempted. In other words, people injured from a class III, PMA-approved device typically cannot recover damages from device manufacturers for their injuries under state common law theories.
In contrast, the Court has said that such claims are generally not preempted under section 521 when they relate to class I devices.
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Power Morcellation OK for Younger Patients, Study Suggests
Nov 17, 2015 | Top Class Actions
By Paul Tassin
A new study suggests that power morcellation might still be a reasonably safe method of uterine fibroid surgery, but only for younger patients.
The study addresses the risk that using power morcellation for hysterectomy or uterine fibroid surgery may inadvertently spread cancer that went undetected prior to the surgery.
Power morcellators are used in laparoscopic surgery to cut tissue into smaller pieces that can be easily removed. The concern is that power morcellation may also shred cancerous tissue and spread it elsewhere in the abdomen.
Doctors are most concerned that this can happen in cases of undetected leiomyosarcoma, a cancer that is difficult to detect prior to surgery and which also resembles non-cancerous fibroids. This risk of morcellation cancer has received increasing attention in recent years, drawing some decisive responses from the medical community as well as a growing number of morcellation cancer lawsuits.
The study was recently published in the American Journal of Obstetrics and Gynecology. It reviewed the results in 2,356 myomectomies, or surgeries performed to remove uterine fibroids.
The researchers found that unexpected leiomyosarcoma occurred less frequently in patients undergoing myomectomy than in those undergoing hysterectomy. In the myomectomy patients, cancer or potential cancer occurred no more frequently than in 1/1000 cases. This was lower than an estimate of 1/498 published by the FDA.
However, the FDA’s numbers included hysterectomy patients. The researchers commented that hysterectomy patients should be considered separately because they tend to be older and thus have a greater risk of unexpected cancer.
The researchers also noted that banning power morcellators outright could result in an increase in morbidity among younger patients. Since younger patients have a much lower risk of leiomyosarcoma, a less invasive procedure like power morcellation might actually be safer for them than open surgery.
The study’s conclusions echo a warning issued by the FDA in November 2014, advising health care providers not to use power morcellation on patients who are peri- or post-menopausal. The FDA also notes such women constitute the majority of women who undergo hysterectomy or myomectomy.
This study is published during a transitional period in the way the medical community uses power morcellator technology. Some health care providers have ceased to use the device altogether due to safety concerns.
In November 2014, HCA Holdings Inc., the operator of 280 different hospitals in the U.S. and England, voluntarily banned the use of the device. Tenet Healthcare Corp. still uses the devices but restricts their use to patients under age 40.
Some manufacturers have also stopped selling power morcellators outright. Johnson & Johnson’s subsidiary Ethicon, the largest maker of power morcellators, first suspended their sales in April 2014 and then stopped sales altogether in July 2014.
On the civil litigation side, manufacturers began to face morcellation cancer lawsuits in small numbers about a year ago, though that number is expected to grow substantially.
One estimate says that Johnson & Johnson alone may face over 5,000 claims related to morcellation cancer. Other, smaller companies that also make power morcellators include Karl Storz GmbH & Co., Blue Endo, LiNA Medical, and Richard Wolf Medical Instruments Corp.
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Power Morcellator Lawsuit Alleges Tool Contributed To Death Of LA Woman
Nov 19, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a wrongful death lawsuit which has been filed against laparoscopic power morcellator manufacturer Ethicon, (a subsidiary of Johnson & Johnson). The lawsuit was filed in Los Angeles, California by the family of a woman who has passed away due to uterine cancer which they allege was spread and upstaged by the morcellator during a surgery to remove painful uterine fibroids.
The lawsuit details that the women underwent a power morcellation surgery in December of 2012. The morcellator device was inserted into her abdomen through a small incision, where it spun tiny blades around inside to shred uterine fibroid tissue. While doing this, however, the family alleges that the device also uncovered, exposed, and spread cancer cells which were previously hidden while they were contained within the fibroids. Post-surgery, the woman was suddenly diagnosed with metastasized uterine cancer, which proved to be fatal.
After many recent lawsuits allege similar complaints, the United States Food and Drug Administration has also stepped forward to warn women against using the device for gynecological surgeries on uterine fibroids. They have noted that there is a risk of spreading previously undetected uterine sarcomas. Additionally, the FDA estimated that 1 in every 350 women who undergo hysterectomy and myomectomy procedures may have hidden uterine sarcomas. They noted that if these women use power morcellation, there is a risk they will spread cancerous tissues and significantly impair their likelihood of survival.
Lawsuits concerning Ethicon power morcellators have been consolidated to form multidistrict litigation. Initial status conference dates regarding the litigation were just announced earlier this week. As these cases await trial, it is anticipated that new cases will join them. The attorneys at Tracey & Fox are working to ensure that anyone who has undergone power morcellation and has subsequently been diagnosed with cancer is able to explore their legal rights. These individuals may be entitled to compensation. At this time, Tracey & Fox is offering free legal consultations to those involved.
For additional information on power morcellator lawsuits, or to ask questions, please contact Tracey & Fox by calling (713) 322-5375.
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Power Morcellator Lawsuit Surge Spurs Congress Letter To G.A.O.
Nov 17, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on details first announced by the Wall Street Journal, indicating that twelve members of Congress had issued a letter to the United States Government Accountability Office in August which requested that the agency investigate laparoscopic power morcellators. The device has been surrounded by much recent controversy as mounting lawsuits allege that it can spread uterine cancer in women undergoing gynecological surgeries, such as hysterectomies and myomectomies.
It was noted that the letter stated: “Hundreds, if not thousands of women in America are dead because of a medical device known as the laparoscopic power morcellator.” The letter was signed by what WSJ termed a “bipartisan group of lawmakers”. The power morcellator tool that this letter refers to works much like a drill. It is inserted into a woman’s abdomen through a small incision, where blades on the device spin to slice apart uterine tissue and fibroid tissue. Allegations state, however, that as this tool shreds the tissue, it can expose uterine cancer cells, and spread them throughout the body.
Many lawsuits additionally allege that this spreading of cancer cells by power morcellators causes victims to be diagnosed with high-grade, widespread cancer post-surgery. The cancer cells, which can be fully encapsulated in uterine fibroids, are almost impossible to detect before the women undergo hysterectomies and myomectomies.
After allegations against laparoscopic power morcellators continued to mount, the United States Food and Drug administration made an announcement warning women against using the device for gynecological surgeries. They cited the risk of spreading uterine sarcomas, and noted that an estimated 1 in every 350 women undergoing these surgeries could have previously undetected uterine cancer, which may be able to be spread by the power morcellator.
The FDA additionally applied a black box warning to the device last November, which is their strongest warning short of pulling the product from the market. Morcellator manufacturer Ethicon, a subsidiary of Johnson & Johnson, has actually ceased all manufacturing of the devices and has recalled those currently in use. Many other manufacturers, however, continue to market and sell laparoscopic power morcellators.
The letter which was sent to the U.S. Government Accountability Office is widely considered long overdue, due to the fact that it was sent “decades after some studies were already pointing to a serious problem.” According to The Wall Street Journal article, the letter stated a question that plaintiffs across the U.S. also echo: “How did they get it wrong for so long?” The question refers to statistics originally presented by the FDA concerning the risk of hidden cancer being substantially lower than recent statements now suggest. The letter noted that “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.”
Power morcellation lawsuits continue to be filed as others await trial. The attorneys at Tracey & Fox are working to ensure that anyone who has undergone a laparoscopic power morcellation procedure and who has subsequently been diagnosed with cancer has the opportunity to fully explore their legal rights. The firm is currently offering these individuals free consultations. Those involved may be entitled to compensation.
For additional information on power morcellator lawsuits, or to ask questions, please contact Tracey & Fox directly by calling 713-322-5375.
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Power Morcellator Lawsuit Claims Tool Caused Upstaged, Aggressive Cancer
Nov 17, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports today on another lawsuit which has been filed against Gyrus Acmi LP, regarding the power morcellator tool they manufacture. This suit joins many others filed against various power morcellator manufacturers from across the nation in the current multidistrict litigation. In this filed complaint, the plaintiff alleges that the morcellator device used for her gynecological surgery exposed and spread cancer cells throughout her body, even outside of the uterine walls. Details in the complaint indicate that post-surgery, the woman was suddenly diagnosed with widespread and upstaged cancer. She alleges that she has been told the cancer will greatly reduce her possibility of survival.
The woman was initially diagnosed with what were believed to be benign uterine fibroids. When cancer is encapsulated in these uterine fibroids, it can be impossible to detect. Surgeons opted to use a power morcellator for her gynecological surgery, as it was a less invasive option to open surgery. The morcellator was inserted through the abdomen via a small incision, where it whirls spinning blades that tear apart fibroid tissue, shredding it so that it is able to be sucked up a tube for removal. Allegations state, however, then when the tool shred the fibroids, it exposed and spread around cancerous cells, which caused the woman to receive a life-threatening diagnosis post-surgery.
Most commonly, power morcellators are used during hysterectomies and myomectomies because they offer faster recovery times than open surgeries. Recently, as lawsuits concerning the tools continued to appear, the U.S. Food and Drug Administration announced a new set of warnings regarding power morcellation. Overall, their safety warning asked that women no longer use the tool for gynecological surgeries involving fibroids, due to the potential that this could spread uterine sarcomas.
Today, lawsuits continue to be filed regularly as those within the current MDL await trial. The attorneys at Tracey & Fox are working to help anyone who has undergone power morcellation and has subsequently been diagnosed with upstage cancer to investigate their full legal rights. These individuals may be entitled to compensation. Currently, Tracey & Fox is offering free legal consultations for those involved.
To obtain more information regarding power morcellator litigation, or to ask questions, please contact the attorneys at Tracey & Fox by calling 713-322-5375.
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