Laparoscopic Electric Morcellators - Update on the Risk of Spread of Unsuspected Uterine Cancer - Notice to Hospitals

Starting date:
December 10, 2014
Posting date:
December 10, 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-42885

Notice about Health Canada advisories

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

December 10, 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: Update - Use of Electric Morcellators during Laparoscopic Hysterectomy and Uterine Myomectomy

On May 7, 2014, Health Canada issued a Notice to Hospitals about the use of laparoscopic electric morcellators during hysterectomy and myomectomy for presumed benign uterine fibroids.Footnote 1 The Notice stated that the use of these devices, which allows for a minimally invasive surgical approach, may result in the spread and upstaging of occult uterine cancer, which cannot be reliably detected preoperatively. 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.Footnote 2

Health Canada has reviewed the relevant clinical and scientific data pertaining to this medical safety issue. Based on the results of its review, Health Canada will be working with device manufacturers to revise the instructions for use of laparoscopic electric morcellators.

Health Canada is requesting manufacturers to include the following warnings in the labelling of electric morcellators:

  • Uterine tissue may contain unsuspected cancer. 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.
  • Laparoscopic electric morcellators are contraindicated:
    • for the removal of uterine tissue containing suspected fibroids in patients who are (i) peri- or post-menopausal, or       (ii) candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision.
    • in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.
  • The risks and benefits of using tissue extraction bags to contain tissue released during laparoscopic electric morcellation procedures remain to be determined.

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 inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7737

References:

Footnote 1

Health Canada. Laparoscopic Electric Morcellators – Risk of Spread of Unsuspected Uterine Sarcoma. Notice to Hospitals. May 7, 2014.

Return to footnote 1 referrer

Footnote 2

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 2 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.