Laparoscopic Electric Morcellators - Risk of Spread of Unsuspected Uterine Sarcoma - Notice to Hospitals

Starting date:
May 7, 2014
Posting date:
May 7, 2014
Type of communication:
Notice to Hospitals
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-39409

Notice about Health Canada advisories

NOTICE TO HOSPITALS - Health Canada Issued Important Safety Information on Laparoscopic Electric Morcellators

May 7, 2014

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Surgery, Gynecology, Oncology, Emergency Medicine, Internal Medicine, Intensive Care and other involved professional staff and post this Notice in your institution.

Subject: Use of Electric Morcellators during Laparoscopic Hysterectomy and Myomectomy - Risk of Spread of Unsuspected Uterine Sarcoma

Electric (powered, motorized) morcellators have helped contribute to the increase in minimally invasive gynecologic procedures (laparoscopic and robotic-assisted) such as hysterectomy and myomectomy for the treatment of women with uterine fibroids. By facilitating the removal of large surgical specimens through small incisions, these devices allow for a minimally invasive surgical approach along with its intended benefits. However, Health Canada is concerned about Canadian and international reports of inadvertent spread of unsuspected uterine malignancies associated with the use of these devices.

Though screening methods exist to detect cervical cancers, there are no reliable ways to detect uterine sarcomas preoperatively. During minimally invasive gynecologic surgery, morcellation in cases of unsuspected uterine sarcoma has been linked with disseminated peritoneal sarcomatosis.Footnote 1 Furthermore, electric morcellation and inadvertent spread of uterine sarcoma would likely negatively impact prognosis, lowering the disease-free and overall survival of affected patients.Footnote 2 A recent scientific analysis by the U.S. Food and Drug Administration determined that the frequency of unsuspected uterine sarcoma in patients undergoing hysterectomy or myomectomy for presumed benign leiomyoma is 1 in 352 and that the frequency of unsuspected uterine leiomyosarcoma is 1 in 498.Footnote 3

In light of this information, Health Canada makes the following recommendations to healthcare professionals treating women with uterine fibroids:

  • Recognize the prevalence of unsuspected uterine sarcoma in patients under consideration for hysterectomy or myomectomy for the treatment of uterine fibroids.
  • Consider the treatment alternatives for women with symptomatic uterine fibroids and review these options with each prospective surgical patient. Apart from a laparoscopic approach, alternative surgical procedures exist that do not require electric morcellation. Also, some surgeons and centers may recommend closed morcellation in a bag as a way to reduce the risk of inadvertent spread of uterine tissue.
  • Be aware and inform patients that laparoscopic electric morcellation of unsuspected uterine sarcoma during hysterectomy or myomectomy may disseminate the disease and negatively impact prognosis.

Health Canada continues to evaluate this medical device safety issue and will provide further updates as necessary.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents suspected of being associated with the use laparoscopic electric morcellators should be reported to Health Canada at the following address:

Any suspected adverse incident can be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline: 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

References:

Footnote 1

eidman MA, Oduyebo T, Muto MG, Crum CP, Nucci MR, Quade BJ. Peritoneal dissemination complicating morcellation of uterine mesenchymal neoplasms. PLoS One. 2012;7(11):e50058.

Return to footnote 1 referrer

Footnote 2

Park JY, Park SK, Kim DY, Kim JH, Kim YM, Kim YT, Nam JH. The impact of tumor  morcellation during surgery on the prognosis of patients with apparently early uterine leiomyosarcoma. Gynecol Oncol. 2011 Aug;122(2):255-9.

Return to footnote 2 referrer

Footnote 3

U.S. Food and Drug Administration. Quantitative Assessment of the Prevalence of Unsuspected Uterine Sarcoma in Women Undergoing Treatment of Uterine Fibroids. Summary and Key Findings. April 17, 2014.

Return to footnote 3 referrer

 

For more information

As an ongoing commitment to openness and transparency, Health Canada has begun to publish summaries of its drug safety reviews. Health Canada is looking at how summary safety reviews for medical devices could eventually be made available.