Lawsuits have been filed by women who developed cancer after undergoing a hysterectomy using a morcellator, an electric tissue-cutting device. Women allege that they were never warned about these risks before undergoing the procedure.
Need a Texas Morcellator Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by a morcellator, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
UPDATE: Morcellator Use Drops Off Dramatically
August 23, 2016 — Only 2.8% of minimally-invasive hysterectomies used power morcellators in early 2015, compared with 13.5% in early 2013, according to a research letter published in JAMA. The rate of complications did not increase. Click here to read more.
April 11, 2016 — More than 20 years after the first power morcellators hit the market, the FDA has approved the first surgical bag to catch tissue fragments that may also contain cancer. Click here to read more.
March 30, 2016 — Ethicon has paid $100,000 – $1 million per case to settle about 70 morcellator lawsuits filed by women who were injured by uterine cancer, according to the Wall Street Journal. Click here to read more.
October 15, 2015 — A panel of judges have centralized all federal lawsuits involving morcellator-induced cancer in the District of Kansas (MDL No. 2652) under Judge Kathryn H. Vratil. Click here to read more.
September 15, 2015 — Olympus Corp. has been sued by a woman from Mississippi who blames a morcellator for spreading undiagnosed uterine cancer. Click here to read more.
August 19, 2015 — A woman who was diagnosed with stage-4 leiomyosarcoma just weeks after a morcellator was used to remove fibroids has filed a lawsuit against the manufacturer and the hospital. Click here to read more.
August 10, 2015 — Congress is calling on the U.S. Government Accountability Office (GAO) to find out why it took the FDA decades to realize that power morcellators pose serious cancer-spreading risks for women undergoing hysterectomies. Click here to read more.
July 6, 2015 — A lawsuit filed on behalf of a woman who died from uterine cancer after she was treated with a morcellator has ended in an undisclosed settlement before it could go to trial against Lina Medical. Click here to read more.
May 27, 2015 — The F.B.I. is investigating how much Johnson & Johnson knew about cancer-spreading hazards of its morcellator surgical tool before pulling them off the market last July. Click here to read more.
May 6, 2015 — Aetna, Inc., the third-largest health plan in the United States with 23 million members, will stop covering routine use of power morcellators. Click here to read more.
April 29, 2015 — A woman who was diagnosed with uterine cancer after undergoing a hysterectomy with a Gynecare X-tract Tissue Morcellator has filed a lawsuit in federal court in Georgia. Click here to read more.
April 8, 2015 — Health insurers covering about 93 million Americans have stopped covering or sharply restricted reimbursements for hysterectomies involving power morcellators. Click here to read more.
February 11, 2015 — Ethicon has been hit with a lawsuit on behalf of a woman who died of cancer 2 years after she was treated with a Gynecare Morcellex morcellator during a hysterectomy. Click here to read more.
February 3, 2015 — A lawsuit has been filed against Karl Storz, Inc. by a woman who was diagnosed with stage-4 bone and breast cancer after a morcellator was used during her hysterectomy. Click here to read more.
January 26, 2015 — Dr. Amy Reed, the leader of a campaign to ban power morcellators because they can spread cancer, has published a scathing critique of the FDA’s 510(k) approval process and failures of medical device safety legislation. Click here to read more.
January 7, 2015 — A team of Canadian researchers have published a study linking the use of power morcellators in hysterectomies and fibroid surgeries with a possible risk of uterine sarcoma and parasitic myomas. Click here to read more.
December 16, 2014 — The FDA did not study the cancer risks of morcellators until 18 years after the surgical tools were approved for gynecological surgery through the 510(k) loophole. Click here to read more.
December 5, 2014 — HCA Holdings, a major chain that owns hundreds of hospitals and outpatient clinics, has banned the use of power morcellators in hysterectomies and fibroid surgeries because the tools might spread cancer. Click here to read more.
November 24, 2014 — FDA adds “Black Box” warning against using power morcellators in gynecological surgery due to the risk of spreading cancer. Click here to read more.
November 5, 2014 — Doctors are warning that women who undergo a hysterectomy or fibroid surgery with the Da Vinci Surgical Robot are usually treated with a morcellator, which is a surgical tool that can potentially spread undiagnosed cancer. Click here to read more.
November 3, 2014 — A woman from New York has died of leiomyosarcoma, a highly-aggressive type of uterine cancer, just two years after a power morcellator was used during a robotic hysterectomy. Click here to read more.
September 25, 2014 — The Wall Street Journal reports that some surgeons are still using morcellators in gynecological surgery despite FDA warnings against its use due to the risk of spreading uterine cancer. Click here to read more.
August 6, 2014 — ObGyn News reports that an advisory panel to the FDA is recommending informed consent and stronger warnings about the risk of power morcellators upstaging cancer when they are used in hysterectomies and fibroid surgery. Click here to read more.
July 30, 2014 — Johnson & Johnson announced plans to ask doctors to return all power morcellators, calling the move a “worldwide market withdrawal” but stopping short of issuing an official recall. Click here to read more.
July 22, 2014 — A study published in Journal of the American Medical Association (JAMA) estimates that one in 370 women who has a hysterectomy using a morcellator actually has undiagnosed uterine cancer, a finding that backs up data published by the FDA earlier this year. Click here to read more.
July 11, 2014 —More than a dozen people, including women with cancer, surviving family members, and physicians asked an advisory panel to the FDA to considering banning morcellators in hysterectomies and fibroid surgery due to the risk of spreading cancer, according to the Associated Press. Click here to read more.
July 8, 2014 — An advisory panel to the FDA will meet on Thursday and Friday this week to discuss ways to mitigate the cancer risks of laparoscopic power morcellators. Click here to read more.
June 17, 2014 — Next month, the FDA will consider regulatory action on morcellators. They may ban the devices, re-classify them as a “high-risk” medical device, require new safety studies, or take no action. Click here to read more.
June 9, 2014 — An advisory panel to the FDA will meet next month to discuss the safety and current regulatory status of morcellators. Click here to read more.
June 3, 2014 — The Pittsburgh Business Times says that a doctor warned Johnson & Johnson that their power morcellator device could spread cancer in 2006, eight years before the products were pulled off the market. Click here to read more.
May 30, 2014 — Manufacturers of power morcellators are now facing about a half-dozen lawsuits from women who allege that they were never warned that the devices can spread cancer if they are used in a hysterectomy or fibroid surgery. Some women only learned about the danger after doing their own research. Click here to read more.
May 7, 2014 — A federal lawsuit has been filed on behalf of a woman who died of cancer after she had a hysterectomy using the LiNA Xcise laparoscopic power morcellator. Another lawsuit has been filed by a woman who is undergoing chemotherapy for uterine cancer after being treated with a morcellator manufactured by Ethicon Endo Surgery Inc. Click here to read more.
April 30, 2014 — Johnson & Johnson’s Ethicon unit, the world’s biggest manufacturer power morcellators, has halted global sales and promotion because the popular surgical tools could spread cancer. Click here to read more.
J&J and Ethicon will stop selling the following morcellators:
- Gynecare Morcellex
- Morcellex Sigma
- Gynecare X-Tract
What is the problem?
An estimated 20-40% of women over age 35 will develop uterine fibroids. Most fibroids are benign, but hundreds of thousands of women have a hysterectomy to remove fibroids every year. The problem is that about 0.2% of of fibroids are actually uterine sarcoma, a rare type of uterine cancer. There is no way to tell if a suspected fibroid is actually cancer until after it is removed.
Unfortunately, when morcellators grind up tissue, they can leave cancerous tissues behind. These tiny pieces of tissue can help an aggressive, rapidly-spreading cancer attach to other organs and start to grow. Cancer can rapidly spread throughout a woman’s abdomen and cause death.
Hysterectomy cancer risks include:
Studies of Morcellator Cancer Risks
In 2011, South Korean researchers presented a study showing that the mortality rate for women with leiomyosarcoma tumors had far better outcomes when their uterus was removed intact — just 19% died after 63 months, compared to 44% after 39 months for women whose tumors were removed using morcellators.
FDA Warning Against Using Morcellator for Hysterectomy or Uterine Fibroids
April 17, 2014 — The U.S. Food and Drug Administration (FDA) has published a Safety Communication to advise against using morcellation in surgery to remove the uterus (hysterectomy) or uterine fibroids (myomectomy). Click here to read more.
According to the FDA:
“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
What is the Alternative?
When the uterus is small enough, it can be removed intact through the vagina. Larger uteruses can be removed with open surgery or cut up with knives. Protective surgical bags can also reduce the risk, and they are commonly used when surgeons cut up suspicious tissues inside the body.
What is a Morcellator?
The laparoscopic power morcellator is a medical device that is used during minimally-invasive surgery, including procedures to treat uterine fibroids. The electrical device uses blades to cut tissue into smaller pieces and fragments that are then sucked out of the body through a tube.
Morcellation is a popular alternative to open abdominal surgery to remove the uterus, which can leave disfiguring scars and require several days of hospitalization. It is promoted as a way to shorten hospital stays, leave smaller scars, and speed up recovery. In the United States, an estimated 55,000 to 75,000 hysterectomies per year involve morcellators.
Types of Morcellators
A few popular types of morcellators include:
- 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
Doctor Warned J&J About Cancer-Spreading Risk in 2006
Dr. Robert Lamparter, a retired pathologist with 28 years of experience, was one of the first to raise alarm about the cancer-spreading risks of morcellators. In 2006, he sent several letters to Ethicon after a “near-miss” involving a woman undergoing a hysterectomy. The surgery began using a morcellator, but doctors were forced to switched to open surgery. After the woman’s uterus was removed whole, doctors found cancer.
In a letter to the company, Dr. Lamparter wrote:
“If this woman had had a morcellization, her tumor would have been seeded into the peritoneum. … In about 1/300 hysterectomies at our hospital, we discover an endometrial carcinoma that was unexpected at the time of surgery. … If a morcellation is done, the patient’s survival is jeopardized.”
Ethicon responded by updating the instruction manual, but they did not report the event to the FDA. Eight years later, Ethicon withdrew all power morcellators from the market. Click here to read more.
Morcellator Class Action
The Clark Firm, LLP is nationally recognized as a class action law firm, but our attorneys are not filing a morcellator class action.Instead, we are filing individual lawsuits on behalf of women who developed cancer after undergoing a hysterectomy or fibroid-removal surgery using a laparoscopic power morcellator.
In October 2015, dozens of lawsuits involving morcellator-induced cancer were centralized in federal court in Kansas (MDL No. 2652) under Judge Kathryn H. Vratil. Click here to read more.
Need a Morcellator Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas morcellator lawyers for a free lawsuit review.