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POWER MORCELLATION and the Risk of Uterine Sarcoma Dissemination

Anonymous woman 200By Dan Bolton, Keller, Fishback & Jackson LLP

An estimated 50,000 women a year in the United States undergo a hysterectomy (removal of the uterus) or myomectomy (removal of uterine fibroids) with the use of a medical device known as a power morcellator.

Power morcellators typically use a rapidly rotating blade to cut (or “morcellate”) fibroids and other tissue into small pieces (approximately 1 cm diameter) that can be removed through small incision sites in a minimally invasive procedure known as laparoscopic surgery.

The high speed of the morcellator blade spreads bits of tissue to other parts of the abdomen and pelvis. If an undetected cancer is present, morcellation can spread malignant tissue, particularly uterine sarcoma, beyond the uterus. This can significantly worsen a woman’s prognosis for long-term survival.

Uterine Fibroids

Uterine fibroid, CT scan, Wiki Commons

Uterine fibroid, CT scan, Wiki Commons

Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus. Most women develop uterine fibroids (known as leiomyomas) during their lifetime, although most cause no symptoms. In some cases, however, fibroids cause symptoms, including heavy or prolonged menstrual bleeding, pelvic pressure or pain, or frequent urination. In these instances, a hysterectomy or myomectomy may be necessary to remove the fibroids.

Uterine Sarcomas

Based on information compiled by the Food and Drug Administration (FDA), 1 in 352 women undergoing fibroid removal (hysterectomy or myomectomy) have an unsuspected uterine sarcoma. In those cases where an unsuspected sarcoma is morcellated, an analysis by the FDA indicates that 25% to 64% of the cases result in abdominal cavity dissemination and/or cancer upstaging to Stage III or IV. Women with unsuspected sarcoma who undergo morcellation may have worse disease-free survival and overall survival than women who do not undergo morcellation.

Uterine leiomyosarcomas are the most common uterine sarcomas, accounting for about 25% to 36% of all uterine sarcomas. Leiomyosarcomas are notorious for their aggressive nature and poor prognosis, and become more dangerous when morcellation spreads the malignancy beyond the uterus. Based on the medical literature, 1 in 498 women undergoing fibroid removal have an unsuspected leiomyosarcoma.

It is difficult to distinguish benign growths from malignant leiomyosarcomas or other uterine sarcomas. There are several reasons for this including 1) the absence of symptoms specific to leiomyosarcomas, 2) the similarity in symptoms between benign leiomyomas and malignant leiomyosarcomas and 3) the location of the malignancy below the surface of the endometrial tissue.

Most leiomyosarcomas are discovered only incidentally after surgery when uterine tissue removed during a hysterectomy or myomectomy is examined by a pathologist. Even an MRI done before surgery does not always give a doctor the ability to distinguish between fibroids and sarcoma.

 

FDA Warns About Sarcoma Dissemination with Power MorcellationFDA logo 100

In April 2014, the FDA issued a safety communication about the risk of spreading unsuspected uterine sarcoma within the abdomen and pelvis when a power morcellator is used for fibroid removal. For this reason, and since there is no reliable method for predicting whether a woman with uterine fibroids may have a uterine sarcoma, the FDA discouraged the use of a power morcellator during hysterectomy or myomectomy.

In July 2014, the FDA convened a two-day meeting of its Obstetrics and Gynecology Devices Advisory Panel (here) to address the safety of power morcellation. Panel members were concerned about the lack of data on the prevalence of uterine sarcoma among women undergoing fibroid removal. Despite the lack of studies, the panel agreed that the magnitude of the risk is too large to be ignored.

Panel members recommended adding much stronger product warnings, known as “black box” warnings, to advise of the sarcoma risk, as well as heightened informed consent requirements to ensure women are fully informed of the serious risks.   The FDA is also considering reclassifying the devices into a more restrictive category—a class III medical device. Several speakers at the hearing called for a ban on the devices.

Gynecare X-Tract Morcellator, Rashmi Hospital, Bangalore

Gynecare X-Tract Morcellator, Rashmi Hospita, Bangalore

Following this hearing, Johnson & Johnson announced a “worldwide voluntary market withdrawal” of three power morcellators, and requested that health care providers return the devices. Johnson & Johnson stated that “the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain.” Other manufacturers continue to market power morcellation devices.

Some well-respected medical centers in the Boston area have banned power morcellation devices after the FDA warning in April. These include Brigham and Women’s Hospital, Boston Medical Center, Tufts Medical Center and Massachusetts General Hospital.

 

Conclusion

Uterine fibroids, Wiki Commons

Uterine fibroids, Wiki Commons

Power morcellators carry a very real risk of spreading unsuspected uterine sarcoma. This risk can lead to stirring up and upstaging aggressive cancers, along with a poor prognosis for survival. Power morcellator manufacturers appear to have known of these serious risks for some time, but have elected to play up the benefits of morcellation, while ignoring the dangers. One wonders why a company would promote a medical device knowing its risk-benefit assessment “remains uncertain.”

Women with cancer that spread following power morcellation have begun filing lawsuits based on the manufacturer’s failure to adequately warn of this serious, indeed life-threatening, risk. Device manufacturers should be accountable for the harm caused by these dangerous devices.

logo bolton two

Dan C. Bolton is Of Counsel in the Los Angeles office of Keller, Fishback & Jackson LLP. The firm represents plaintiffs nationwide in pharmaceutical and medical device litigation, including power morcellation cases.  Mr. Bolton oversees the pharmaceutical and medical device practice. 

4 Comments

  1. Jane Akre says:

    Storz, the maker of one power morcellator, wrote this letter to the husband of Dr. Amy Reed, who issuffering cancer after a power morcellator ground up her uterine sarcoma, perhaps making it more toxic to her. They do not believe the pm causes the cancer. (DUH) The point is it spreads it… not causes it. Why not just be honest! Don’t try to confuse the issue.

    https://dl.dropboxusercontent.com/u/109043810/STORZ_Letter.pdf

  2. Pam says:

    I just did some research for this, and seen where one doctor was able to get the MEDIA and FDA involved with only one alleged injury. By all means I agree with the Dr, and it is a travesty that Doctors creating this method could possibly worsen a case that was contained and treatable.

    However, my question still poses that maybe we need to do what these people did, and send in picture collage of faces of women that are affected by MESH. I’m still not sure why the MEDIA, and FDA has not brought this to light. Let alone more and more doctors continue to put more women at risk. I have yet to see any women opposing the MESH being banned, and only the Manufacturers and Doctors are claiming this to be a Gold Standard treatment because it is lining their pockets full of GOLD by producing NEGLIGENT treatment

  3. Barb says:

    It is up to us MESH INJURED to create havic enough so the red light goes off for the media to say hey this is real thousands suffer and really get complaints to the FDA!! Makes me wonder just how many FDA employee’s really require the proper testing, Do their research on every piece of material used in these products!! To me there is n Gold Standard for womans/mens health anymore. So now just another issue for JNJ to be properly investigated!! I would much rather have a complete hysterectomy at this point instead of dealing with any product on the market!! Instead of doing a surgery less invasive why don’t we all say NO MORE!! I will at some point down the road be having the BURCH procedure, I will no longer trust any doctor wanting to use some type of foreign device ever again!! Due to so many complications caused by MESH my doctor said I will never be 100% again however she also will not perform the BURCH until she gets me the best I can be!! Great article Jane!! Something I never heard of. I nor do our doctors know what each of us will face down the road…………WE MUST GO TO THE MEDIA and not use our real names as it could cause an issue for our cases but my gosh let’s do something ring everyone’s bell, wave red flags call as many media outlets as we can. Because of all the issues I have I wish a full hysterectomy, that would take hopefully all mesh out, take care of organ prolapse and use our own natural tissue, although with all the poisons , I already have been diagnosed with Septis infection in the bloodtream what has this done to just not my other organs but other’s too!! Thank you Jane!!

    • Jane Akre says:

      The resources are at the bottom of the story to contact Congress…. not sure they care but they sure need to hear from you and not just industry, who we know they listen to!

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