Laparoscopic power morcellators, 29 April 2014

Safety advisory - potential issues when used for uterine surgery in patients with fibroids

29 April 2014

The TGA has published updated advice regarding this issue. For the latest information please refer to the safety advisory published on 4 August 2014.

The US Food and Drug Administration (FDA) has published a safety communication advising against the use of laparoscopic morcellators during certain uterine surgery procedures in patients with fibroids because of the potential for the devices to spread malignant cells in patients with previously undetected uterine cancer.

These procedures include hysterectomy and myomectomy.

Laparoscopic morcellators are devices used to cut tissue into smaller pieces to aid removal during minimally invasive ('keyhole') surgeries, including procedures to remove fibroids.

The FDA has not recalled this device but has issued a safety alert and the TGA is actively investigating what actions should be undertaken in Australia and will obtain advice from its expert advisory committee, the Urogynaecological Devices Working Group. The TGA will provide further information as it becomes available.

In the meantime TGA has contacted the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Australian Gynaecological Endoscopy Surgery society and the UroGynaecological Society of Australasia to alert them to this issue.

Information for consumers

If you have undergone a laparoscopic uterine procedure and you are concerned about this issue, contact your general practitioner or surgeon for individual clinical assessment and advice.

Women considering treatment for fibroids should ensure that they discuss the benefits and risks of all the treatment methods available with their health professional.

Information for health professionals

Health professionals who are treating a patient who has undergone laparoscopic uterine surgery should be alert to this issue and the potential complications.

The FDA conducted a review of nine studies to estimate the prevalence of unsuspected uterine sarcoma and uterine leiomyosarcoma in patients undergoing hysterectomy or myomectomy for presumed benign fibroids. The analysis concluded that the prevalence of unsuspected uterine sarcoma in patients undergoing hysterectomy or myomectomy for presumed benign leiomyoma is 1 in 352 and the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498. A summary of the analysis is available on the FDA website.

While we investigate this issue, health professionals are strongly advised to consider whether to use alternative treatment methods for patients with symptomatic uterine fibroids where definitive exclusion of malignant change cannot be made. Health professionals should discuss the benefits and risks of the treatment methods available with their patients.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.