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On 29 December 2020, the US Food and Drug Administration (FDA) published an updated safety communication for laparoscopic power morcellators. The FDA recommends the use of laparoscopic power morcellators for hysterectomy and myomectomy only be conducted with a tissue containment system, which is legally marketed within the US market. Tissue containment systems used during laparoscopic power morcellation are intended to isolate and contain tissue that could potentially spread malignant cells in patients with previously undetected uterine cancer. The FDA also continues to recommend performing these procedures only in appropriately selected patients.
The FDA also published their final guidance on product labelling for laparoscopic power morcellators on 29 December 2020. The FDA recommend manufacturers use the guidance on product labelling to provide greater specificity regarding the risk of use as it relates to age; information regarding the risk of spreading malignant and benign uterine tissue; and information relating to the use of a containment system. These recommendations aim to enhance the discussion of the benefits and risks of using laparoscopic power morcellators for appropriately selected patients and their physicians.
The Therapeutic Goods Administration (TGA) has reviewed the current Instructions for Use (IFU) and training documentation for six laparoscopic power morcellators on the Australian Register of Therapeutic Goods (ARTG) to ensure they are aligned with the latest safety advice.
The TGA has reviewed the IFUs to ensure they include the appropriate contraindications, warnings and precautions. This includes warning that the use of laparoscopic power morcellation may spread undiagnosed malignant and benign cells; the devices should only be used with a compatible containment system; and that laparoscopic power morcellation is contraindicated for removal of uterine tissue for those who are over 50 years of age or who are post-menopausal.
As a result of the post market review, the IFUs were updated for four laparoscopic power morcellators, resulting in two Product Defect Corrections recall actions (see System for Australian Recall Actions for details). Two sponsors intend to cancel their devices in the coming months and one device has already been cancelled by a sponsor.
The TGA has recently identified a further five morcellator devices on the ARTG. Further investigation is underway to ensure these devices remain compliant with the latest safety advice.
Update 3 - Further review underway
16 October 2020
The Therapeutic Goods Administration (TGA) is reviewing the current Instructions for Use and training documentation for laparoscopic power morcellators to ensure they are aligned with the latest safety advice.
This advice recommends using a tissue containment system for certain uterine surgical procedures in patients with fibroids. The advice also highlights the importance of informed consent and ensuring patients and practitioners are aware of the risks of using laparoscopic power morcellators.
Laparoscopic power morcellators are devices used to cut tissue into smaller pieces to aid removal during minimally invasive ('keyhole') surgeries. For example, these devices may be used in a hysterectomy (removal of the uterus) or a myomectomy (removal of fibroids). A fibroid is a growth that develops from the muscular tissue of the uterus.
The TGA's Advisory Committee on Medical Devices (ACMD) met on 16 April 2020 to provide advice following the publication of a safety communication by the US Food and Drug Administration (FDA). The FDA advised that the use of laparoscopic power morcellators for certain uterine surgical procedures in patients with fibroids should only be conducted with a tissue containment system. These surgical procedures include hysterectomy and myomectomy. Tissue containment systems used during laparoscopic power morcellation are intended to isolate and contain tissue that potentially could spread malignant cells in patients with previously undetected uterine cancer. This advice is an update to a 2014 safety communication where the FDA advised against the use of laparoscopic power morcellators in patients with fibroids.
The ACMD recommended that the TGA should follow the guidelines of the FDA in not sanctioning the freehand use of laparoscopic power morcellators and the recommendation of the use of a containment device. This advice is based on the random occurrence of uterine cancers in fibroids and the virtual impossibility of diagnosis prior to histopathology.
The ACMD concluded that there is a place for laparoscopic power morcellation in these types of surgery and that patients must be made aware of the risk in using these devices. As such, tissue morcellation should be an option with appropriate consent of the risks, education of the patient and training of the practitioner.
The TGA published an article in the May 2015 issue of Medical Devices Safety Update following a review of the Instructions for Use in response to the FDA 2014 safety communication. On 1 August 2014, the TGA published a safety advisory providing an update on the advice following a Urogynaecological Device Working Group meeting.
Information for consumers
If you have undergone a laparoscopic uterine procedure, such as a laparoscopic hysterectomy or laparoscopic myomectomy, and you are concerned about these issues, contact your general practitioner or surgeon for individual clinical assessment and advice.
Women considering treatment involving a laparoscopic uterine procedure 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 should ensure they involve each patient in a full discussion of the risks and benefits before undertaking laparoscopic morcellation.
Health professionals undertaking laparoscopic morcellation should be alert to the potential for:
- transcoelomic spread of undiagnosed cancerous tissue, particularly leiomyosarcoma
- disease such as iatrogenic endometriosis, benign leiomymatosis and occult malignancy
- abdominopelvic recurrence of endometrial stromal sarcoma
- abdominal dissemination of leiomyomatosis.
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