FDA warns about Laparoscopic Uterine Power Morcellation


On April 30, 2014, Johnson & Johnson suspended worldwide sale of its power morcellator, a device used during laparoscopic minimally invasive surgery to help remove large specimens (uterus, fibroids…) through small incisions. “This comes amid concerns over its potential to spread undetected cancer beyond the uterus.” according to Reuters.

On On April 17, 2014, the US Food and Drug Administration FDA issued a safety communication titled: “Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication”

FDA logo - Dr. Hasan AbdessamadIn brief it states:

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.

The FDA recommends the following for Health Care Providers:

  • Be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.
  • Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.
  • Carefully consider all the available treatment options for women with symptomatic uterine fibroids.
  • Thoroughly discuss the benefits and risks of all treatments with patients.
  • Forindividual patients for whom, after a careful benefit-risk evaluation, laparoscopic powermorcellationis considered the best therapeutic option:
    •  Inform patients that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.
    • Be aware that some clinicians and medical institutions now advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.

The FDA recommends the following for Womyn:

  • Ask your health care provider to discuss all the options available to treat your condition and discuss the risks and benefits of each.
  • If laparoscopic hysterectomy or myomectomy is recommended, ask your health care provider if power morcellation will be performed during your procedure, and to explain why he or she believes 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 provider.

AAGL logo - Dr. Hasan Abdessamad

The first response came from the American Association of Gynecologic Laparoscopists (AAGL):

The AAGL is reviewing the scientific evidence and best practices reported by our members to provide readily accessible, comprehensive information to our members… We encourage our members to fully research and understand the risks of power morcellation and to learn more about when alternative methods of tissue extraction may be appropriate.

AAGL is establishing a task force to address this emerging evidence.

The FDA is convening a public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee to provide better guidance to manufacturers and physicians. 

The FDA has ignored a previous communication from AAGL “encouraging them to use the AAGL as a resource as they evaluated data on complications related to power morcellation” according to a third member update sent by AAGL on Apr. 21, 2014.

Until we get better guidance from our medical associations and a consensus from experts in the field, my counselling to patients will include this rare complication. I will state the risk quoted by FDA: “it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.” Even though, I wish their statement included a reference to the original research from which the 1/350 figure was obtained.

Uterine sarcomas are extremely rare. I do not recall coming across any case in my training or practice. There was one case of a leiomyosarcoma in my family that developed years after an open hysterectomy with no morcellation. The quoted incidence of uterine sarcomas is 0.36 per 100,000 woman-years in the United States (US) from 1979 to 2001, or 3 to 7 per 100,000 US population from 1989 to 1999, based on data from the Surveillance, Epidemiology and End Results national cancer database according to UpToDate’s “Uterine sarcoma: Classification, clinical manifestations, and diagnosis” that was last updated on Jan. 28th 2014.

Even though this statement might seem to hinder our efforts to provide gynecological minimally invasive surgery to a larger number of womyn, I believe it will only improve our performance. This will encourage surgeons to adopt new techniques that mitigate the risk (even if small), like morcellating within a bag, wether power or manual, wether abdominal or vaginal.

LIGO logo - Dr. Hasan Abdessamad

I will be a suturing preceptor at the Laparoscopic Institute for Gynecology and Oncology (LIGO) Masters’ Course in Laparoscopic Surgery in San Francisco, California, USA from May 15 to 17, 2014. I will update you on the general consensus among LIGO experts. I am sure this will be a highly debated/discussed topic.

Here is a video response from LIGO’s chairwoman and founder Dr. Kate O’Hanlan:

 

For now, and until further evidence or guidance arises, I will continue to offer the option of power morcellation to adequately selected and appropriately counselled patients who wish to avoid the morbidity of an open procedure (the traditional route of hysterectomy using a large abdominal incision, also called abdominal hysterectomy or laparotomy) and in whom power morcellation is the only feasible option that allows for a minimally invasive surgery.

 

This post was edited on April 23, 2014 – New content was added in blue.

This post was edited on May 05, 2014 – New content was added in red.



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