A growing number of product liability lawsuits are being filed over the use of power morcellators, medical devices used during hysterectomy and myomectomy surgeries. The U.S. Food & Drug Administration (FDA) has warned that morcellators can spread undetected cancer cells into other parts of women’s bodies.
The lawsuits are for women who were cancer spread throughout their bodies after undergoing the surgery with a laparoscopic power morcellator.
Free Case Evaluation: If you or a loved one was diagnosed with cancer after undergoing surgery with a power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit against the manufacturer of the morcellator and our lawyers can help.
Morcellators do the cutting in laparoscopic and robotic surgeries, breaking large tissue masses into small fragments with the help of tiny rotating blades. The broken-down tissues are then vacuumed out of the patient’s body. Power morcellation requires incisions of less than 2 centimeters to remove fibroids and other tissue. These tiny incisions mean doctors do not have to make large cuts through the patient’s core stomach muscles. The technique has led to quicker patient recovery times, less pain, and fewer complications.
Hysterectomy and Myomectomy
A hysterectomy is an operation designed to address problems that occur in the female reproductive system. The procedure may involve the removal of all of a woman’s reproductive organs (uterus, ovaries, and cervix) or just one or two problematic areas. Hysterectomies are typically used to treat cancer, endometriosis, uterine fibroids, chronic pelvic pain and bleeding, polyps, uterine prolapse, or adenomyosis (thickening of the uterus).
A myomectomy involves the surgical removal of uterine fibroids. The procedure allows the uterus to be left intact and may make pregnancy more likely to occur.
Myomectomies are the preferred fibroid treatment for women who want to get pregnant at some point in the future.
What’s the Problem?
Unfortunately, power morcellators have recently been linked to the spread of an aggressive form of uterine cancer called leiomyosarcoma. Since 2013, numerous morcellator cancer lawsuits have been filed against Ethicon Inc., Blue Endo, Lina Medical and other companies that make the devices. Plaintiffs allege they were never warned that morcellators can “seed” undiagnosed leiomyosarcoma in uterine fibroids, leading to the spread of cancer.
FDA Warning on Power Morcellators
On April 17, 2014, the FDA issued a Safety Communication advising surgeons not to use laparoscopic power morcellators during hysterectomy or myomectomy procedures due to the risk that the devices may spread cancerous uterine tissue to other parts of the body. Based on current data, FDA estimates that of the approximately 600,000 hysterectomy surgeries performed in the U.S. each year:
- 30% are performed laparoscopically in women younger than 40
- 44% in women ages 40 to 49
- 16% in women ages 50 to 59
The agency has determined that about 1 in 350 women who undergo a hysterectomy or myomectomy surgery for uterine fibroids have an unsuspected form of cancer called uterine sarcoma. If laparoscopic power morcellators are used on these women, there is a significant risk that the device will spread cancerous tissue into the abdomen and/or pelvis.
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”
In February 2015, a study published in Obstetrics & Gynecology found undetected uterine sarcomas in 2.7% (about 1 in 368) of 2,575 women who underwent fibroid removal surgery. Morcellators may spread the cancerous tissue, which is typically not diagnosed before surgery. Patients should be informed of “the possibility of a poorer prognosis should an unidentified malignancy be morcellated,” the researchers concluded.
Another study published the same month in JAMA Oncology found that the risk of spreading cancerous tissue via power morcellators increases with age. The researchers found that from 2006 to 2012, 7.7% of 41,777 myomectomies were performed with morcellators. “Electric power morcellation should be used with caution in older women undergoing myomectomy” the authors said.
What is Power Morcellation?
Laparoscopic power morcellation is a form of fibroid treatment that uses a special device to divide uterine tissue into smaller pieces so it can be removed through a tiny incision in the abdomen, such as during a laparoscopic procedure. Before these devices became available, morcellation was performed using a machine that required the surgeon to manually ‘squeeze’ the handle, or use a scalpel to create small specimens that could be removed from the abdominal cavity. The first electronic power morcellator was introduced to the U.S. market in 1993.
List of Morcellators & Manufacturers
These devices are now made by a number of different U.S. manufacturers including:
- FemRx – Diva Morcellator
- Hologic – MyoSure
- Lumenis Inc. – VersaCut Morcellator
- Ethicon Gynecare – X-Tract
- Ethicon Gynecare – Morcellex Tissue Morcellator
- Ethicon – Morcellex Sigma
- Interlace Medical – Hysteroscopic Morcellator
- Smith & Nephew – Trueclear Hysteroscopic Morcellator
- Olympus – PlasmaSORD
- Olympus – Gyrus PKS PlasmaSORD
- Nouvag – Morcellator TCM3000BL
- Blue Endo – MOREsolution Tissue Morcellator
- LiNA Medical – Xcise Cordless Laparoscopic Morcellator
- Karl Storz – Rotocut G1, G2, Steiner, and Sawalhell Supercut Morcellator
- Richard Wolf – Morce-Power 2306 Electronic Morcellator
J&J to Settle Morcellator Cancer Lawsuits
Johnson & Johnson is settling a number of product liability lawsuits alleging that its power morcellators harmed women by spreading undetected cancer cells during routine laparoscopic procedures.
About 100 lawsuits have been filed or prepared against J&J’s Ethicon unit over injuries allegedly caused by the company’s laparoscopic power morcellator device, according to The Wall Street Journal. Of these complaints, nearly 70 have been settled over the past few months.
It’s still unclear exactly how much J&J will offer to settle the cases. Morcellator settlements have ranged anywhere from $100,000 to about $1 million; the company will likely spend many millions more before the litigation process is complete.
What Are Uterine Fibroids?
Uterine fibroids are benign (non-cancerous) growths that develop in the smooth muscle tissue in the wall of the uterus. According to the National Institutes of Health (NIH), most women will develop these growths at some time in their lives. While most uterine fibroids are relatively harmless, they can cause symptoms that require medical or surgical therapy including:
- Heavy or prolonged menstrual bleeding
- Pelvic pressure or pain
- Frequent urination
Study Links Power Morcellators to Increased Risk of Death
In May 2011, a South Korean study demonstrated that women had far worse outcomes when a power morcellator was used to remove uterine tumors — 44% died after 39 months, compared to 19% after 63 months for women who had their uterus whole.
“Tumor morcellation and spillage during surgery may adversely affect treatment outcomes in patients with these highly malignant tumors,” said Jeong-Yeol Park, MD, Clinical Assistant Professor of Medicine at Asan Medical Center in Seoul.
The Federal Bureau of Investigation is looking into what J&J knew about the risks of power morcellation before the company pulled its devices off the market last year, according to the Wall Street Journal. The investigation equals more bad news for power morcellators, amid tightening restrictions on reusable medical devices by health insurers and U.S. regulators – particularly apt since the recent superbug outbreaks. Click here to learn more.
Despite Risks, Surgeons Continue to use Morcellators
Since the FDA issued its warning on the risks of power morcellators in April 2014, a number of hospitals put moratoriums on the tools and some insurers stopped covering their use. However, in spite of the dangers, many doctors are still using the devices. Robert Graebe MD, Department of Obstetrics and Gynecology chairman at Monmouth Medical Center, first thought the FDA had overreached but now agrees with the agency. He thinks power morcellators should be shelved until more studies can be conducted into their potential health risks.
He told Wall Street Journal, “People want to fight back, but it’s not putting patients’ safety first. It’s not worth playing Russian roulette with the patient.”
Ethicon Morcellator Wrongful Death Lawsuit
A wrongful death lawsuit has been filed on behalf of a Missouri woman who allegedly died after undergoing a laparoscopic hysterectomy and uterine fibroid removal surgery with an Ethicon Gynecare morcellator. Ms. Carl Cecilia Merrill had her uterus and fibroids removed in December 2012; she later learned that the device had spread previously undetected cancerous tissue throughout her peritoneal cavity, causing a rapid upstaging of the disease. Click here to learn more
HCA Hospitals Ban Use of Power Morcellators for Fibroid Removal
HCA Holdings Inc., the largest for-profit hospital operator in the U.S., said power morcellation for uterine fibroid removal will no longer be performed at its facilities after the procedure was linked to the spread of cancer. HCA’s decision follows new warnings regarding morcellator use issued by the U.S. Food and Drug Administration.
HCA’s decision to ban power morcellators marks one of the first major shifts concerning the controversial medical devices since the FDA’s Nov. 24 warning. The agency said morcellators should not be used in the “vast majority” of women undergoing surgery for fibroid removal because the procedure could spread undetected cancers called sarcomas beyond the uterus.
Prior to the FDA’s most recent warning, HCA advised surgeons to follow the agency’s previous guidance, which discouraged power morcellation for fibroid removal. It wasn’t immediately clear if HCA’s physicians had been using morcellators regularly. The company’s new ban on morcellators is currently underway and applies to all its approximately 160 hospitals and 115 surgery centers in 20 states around the country.
FDA Strengthens Warning Against Use of Power Morcellator for Fibroid Removal
The U.S. Food & Drug Administration (FDA) has strengthened its warning about the cancer-spreading risk associated with laparoscopic power morcellators, saying the devices should not be used for most women during fibroid removal surgery.
The FDA first warned about the risks of power morcellators in April 2014, discouraging the use of the devices based on data indicating that hidden sarcomas are much more common than previously realized. The agency confirmed that analysis in its updated warning on November 24, stating that approximately 1 in 350 women undergoing fibroid removal surgery have unsuspected cancerous cells found in later testing.
FDA said it is recommending that companies who make morcellators immediately update their products’ labeling to include a “boxed warning,” and to detail specific cases where the devices should not be used.
“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”
The updated warnings will state that uterine tissue may contain previously undiagnosed cancers that power morcellators could spread to other parts of the body. The contraindications note that morcellators should not be used to remove uterine tissue in women who have gone through or are in the process of transitioning into menopause.
Additionally, the devices shouldn’t be used in women who could have their uterus removed through their vagina or in a “mini-laparotomy,” which is a larger incision than a morcellator requires but not considered open surgery. These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy surgeries, according to the FDA.
Hopkins Protocol Seeks to Minimize Power Morcellator Cancer Risk
To reduce the spread of cancerous tissue during fibroid removal and hysterectomy surgeries, Johns Hopkins University has announced it will no longer use power morcellators on women over the age of 50. Under the so-called “Hopkins Protocol,” morcellation will also be contraindicated in women who have risk factors for gynecologic cancer including tamoxifen use, pelvic radiation, and hereditary cancer syndromes.
Under the university’s new guidelines, morcellation may only be performed on qualified women by high-volume surgeons who use endoscopy bags to catch tissue spills. Endometrial sampling and imaging tests – including an MRI to look for uterine fibroids – must be performed to rule out undetected sarcomas, and women must be warned of the cancer risk before undergoing surgery.
“Given the review of our institutional data and recent national debate surrounding power morcellation, our institution developed the protocol to enhance safety for women [undergoing] minimally invasive surgery for benign indications,” said Dr. Stephanie Ricci, a gynecologic oncology fellow at Hopkins.
The new protocol was announced just days before the U.S. Food & Drug Administration (FDA) issued an updated warning on power morcellators, advising surgeons to avoid using the devices on peri- or postmenopausal women, and when tissue can be removed en bloc either vaginally or by mini-laparotomy, which is the case with most hysterectomies and myomectomies. Women must also be warned of the cancer risk before surgery, FDA said on Nov. 24.
Hopkins developed its protocol based on a review of 424 morcellation surgeries performed at the university between 2005 and 2014. Two patients who underwent the procedure were subsequently diagnosed with occult cancers, giving an incidence of 0.47%.
Taken together, the Hopkins protocol and the FDA’s new guidelines could help better clarify the narrow pool of women for whom power morcellation might still be a viable option, be it to preserve fertility or for some other health reason.
Senators Call For “Across-the-Board” Morcellator Recall
Senators Kirsten Gillibrand (D-NY) and Charles Schumer (D-NY) recently wrote a letter to the FDA urging the agency to order a comprehensive nationwide recall of all power morcellators. Specifically, the senators have asked that all remaining manufacturers initiate mandatory product recalls, including:
- Olympus Corp.
- Karl Storz
- LiNA Medical
- Richard Wolf
- Smith & Nephew
- Interlace Medical
To date, none of these companies have made any effort to recall their power morcellators.
Insurance Companies Considering Limits on Uterine Morcellation
The health insurance industry is calling for stronger regulation over the approval of power morcellators, citing a regulatory loophole exposed last year when the device was found to spread undetected cancer cells during routine gynecologic procedures.
The trade group America’s Health Insurance Plans sent a letter this week to Senator Bob Casey (D-PA) regarding how problems associated with laparoscopic power morcellators reveal weaknesses in how the devices are approved and monitored, according to the Wall Street Journal.
Casey wrote the group in part to gauge the insurance industry’s response to a Nov. 2014 FDA warning on morcellators, and to determine whether health plans track adverse events related to the devices. The agency warned that power morcellators shouldn’t be used on the vast majority of women undergoing hysterectomy and fibroid removal surgery.
Women requiring fibroid removal have a greater risk of developing uterine sarcoma than previously understood, the FDA said. The morcellator, which pulverizes and removes tissue through tiny incisions, could spread and worsen cancer, the agency said.
As a result of these problems, 3 of the 4 largest insurers have limited coverage for procedures involving power morcellators. The use of the devices has declined significantly since the FDA warning.
Aetna to Drop Morcellator Healthcare Coverage
Healthcare insurer Aetna Inc. has announced that it will stop covering the routine use of laparoscopic power morcellators, marking a major hit to a controversial surgical tool that has been found to spread undetected cancer in women during routine gynecologic procedures.
Aetna will begin implementing its new healthcare plan later this month, according to a company spokesperson. The updated policy will not provide coverage for power morcellation, commonly used to remove fibroids during hysterectomy surgery, under most circumstances.
Aetna will require doctors to obtain approval for any procedure that involves the use of a power morcellator, according to the Wall Street Journal. Doctors can request exceptions for women who want to preserve fertility and have no other options, as well as in cases where another type of procedure could be life-threatening or lead to adverse health complications.
“The policy takes into account the latest FDA warnings about the risk that morcellation can spread unsuspected uterine sarcoma in the abdomen and pelvis,” said Aetna spokeswoman Cynthia Michener.
The company said it is urging doctors to talk to patients about the potential risks and benefits of morcellation, as well as alternatives.
Morcellator Cancer Death Lawsuit Filed in Boston
The widower of a woman who died in 2013 after undergoing a robotic hysterectomy with a power morcellator at Brigham and Women’s Hospital (BWH) has filed a lawsuit against the medical center, the latest in a growing number of complaints involving the controversial medical devices.
Plaintiff Rick Kaitz alleges BWH knew that laparoscopic power morcellators could spread undetected cancer, but that the hospital failed to inform his wife about this risk. Erica Kaitz died in Dec. 2013 at the age of 52, about 18 months after undergoing the surgery.
The wrongful death lawsuit, which was filed last week in Suffolk County Superior Court in Boston, also names the surgeon who performed the procedure and Karl Storz GmbH & Co. KG, the company that made the morcellator.
Health Canada Issues Second Warning on Power Morcellators
Canada’s federal health agency has sent out a second letter to hospitals in that country regarding health risks associated with using power morcellators for hysterectomy and fibroid removal surgery. Health Canada’s notice follows a similar safety warning issued by the U.S. Food and Drug Administration (FDA) on Nov. 24, which stated that uterine tissue may contain previously undiagnosed cancers that power morcellators could spread to other parts of the body.
Health Canada first warned about power morcellators in May 2014, stating that the devices can cause undetected cancers to spread.
“The frequency of unsuspected uterine cancer in women undergoing surgery for the removal of presumed benign fibroids has now been estimated to be in the range of 1-in-350, which is more prevalent than previously reported,” the agency said.
According to the Dec. 10 warning, Health Canada now wants manufacturers of power morcellators to include warning labels on the devices. The agency also said morcellators should not be used in most cases.
“The use of laparoscopic electric 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,” Health Canada said.
The latest warning also said that morcellators should not be used on women who have gone through or are in the process of transitioning into menopause, as well as on any women who are candidates for alternative minimally invasive procedures that don’t require morcellation.
Doctors Should Avoid Using Power Morcellators for Hysterectomy, J&J Says
Healthcare giant Johnson & Johnson is urging surgeons not to use a device that has recently been found to spread certain types of uterine cancer in women. Sales of J&J’s laparoscopic power morcellators were halted earlier this year after the FDA issued a warning statement regarding the devices. The agency warned that when used for hysterectomy and fibroid removal surgeries, morcellators could spread sarcoma in some patients, lowering the chances for survival.
A pair of new studies — from the U.S. Food & Drug Administration (FDA) and researchers at Columbia University — determined that approximately 1 in 350 women has undiagnosed cancer when undergoing fibroid surgery; for women requiring hysterectomy operations, the risk is about 1 in 368.
As a result of these findings, J&J is now expanding the pullback on its power morcellators, urging those who have purchased one to discontinue use of the device and return it immediately. According to an article published in the Wall Street Journal, Johnson & Johnson originally stood by its morcellators, but now says the risk of spreading cancer outweighs any potential benefits. Though sales of the device only represent a tiny fraction of J&J’s business, the company represents nearly 75% of the U.S. market share for laparoscopic power morcellators.
Uterine Sarcoma (Leiomyosarcoma)
Leiomyosarcoma is a rare but highly aggressive form of cancer that occurs in smooth muscle cells of the uterus or gastrointestinal tract. Uterine leiomyosarcoma (ULMS) develops in the muscular part of the uterus and typically occurs in women between the ages of 40 and 60. ULMS tumors are highly metastatic, with nearly 70% of patients who have had their tumors removed seeing a recurrence within 8 to 16 months.
In nearly 80% of patients who have a recurrence, the disease has spread to other parts of the body such as the ovaries, lungs, or liver. When this occurs, it is referred to as metastatic leiomyosarcoma and classified as either stage III or IV. Patients with non-metastatic leiomyosarcoma have a 5-year survival rate of approximately 50%, while the 5-year survival rate for patients with metastatic leiomyosarcoma is between 4 and 16%.
Philadelphia Women File Lawsuits Alleging Olympus Morcellator Spread Cancer
Two Philadelphia women have filed lawsuits against Olympus Corp. alleging that the company’s laparoscopic power morcellators spread cancer throughout their bodies.
The lawsuits, which were filed separately in the Court of Common Pleas of Philadelphia County, accuse Olympus and its subsidiary Gyrus ACMI of misrepresenting their morcellators as being safe, and of failing to adequately warn doctors and patients about the cancer risk associated with the devices.
Morcellators are used to chop uterine tissue into small fragments for removal during a hysterectomy or myomectomy surgery. However, the devices have been reported to spread uterine tissue containing undiagnosed cancer cells into the abdominal and pelvic cavity, where Lawsuit Allegations
The Pennsylvania lawsuits allege that Olympus and Gyrus failed to design their morcellator safely and that the companies knew or should have known of the dangers associated with the devices. The complaints are: (Case Nos. 150401310 and 150401312, Court of Common Pleas, Philadelphia County).
FDA Recommendation on Use of Morcellators
According to the FDA, A number of safer treatment options are available for women with uterine fibroids, including:
- Traditional surgical hysterectomy (performed either vaginally or abdominally)
- Laparoscopic hysterectomy and myomectomy without morcellation
- Other non-surgical options
Until more comprehensive data is available, FDA has instructed manufacturers of laparoscopic power morcellators to review their product labeling for adequate warnings risk information.
If you are considering surgery with a laparoscopic power morcellator, the FDA recommends that you:
- Discuss all the options available to treat your condition, including the risks and benefits of each with your health care professional.
- If laparoscopic hysterectomy or myomectomy is recommended, ask your health care professional if power morcellation will be performed during your procedure and why it is the best treatment option for you.
- If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health care professional.
Do I Have a Morcellator Cancer Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Morcellator Lawsuits. We are handling individual litigation nationwide and currently accepting new cancer cases in all 50 states.
Again, if you or a loved one developed cancer after undergoing surgery with a power morcellator, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.