Laparoscopic power morcellators - Update 2

Safety advisory - update following Urogynaecological Devices Working Group advice

4 August 2014

The TGA's Urogynaecological Devices Working Group (UDWG) met on 17 June to provide advice following a safety communication published by the US Food and Drug Administration (FDA) in April which advised against the use of laparoscopic morcellators during certain uterine surgery procedures.

The FDA advised against the use of the devices in patients with fibroids because of the potential for the devices to spread cancerous cells in patients with previously undetected uterine cancer. These procedures include hysterectomy and myomectomy.

The TGA has previously issued a safety advisory regarding the issue on 29 April.

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

Following consideration of the advice provided by the UDWG, the TGA advises that there is currently insufficient evidence in the Australian population to conclude that the use of laparoscopic morcellators increases the risk or rate of adverse outcomes by spreading cancerous tissue through the abdomen. However, the TGA will continue to monitor this issue and update this information should it become necessary.

The TGA is aware that Johnson & Johnson Medical Pty Ltd is withdrawing its Ethicon power morcellators (Product Codes MX0100R, MD0100 & DV0015) from the Australian market.

Information for consumers

If you have undergone a laparoscopic uterine procedure 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.

Evidence considered

The evidence considered by the UDWG included a statement from the Australasian Gynaecological Endoscopy & Surgery (AGES) Society and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) which noted that the incidence of leiomyosarcoma (LMS) has been variably quoted at between 0.02 to 0.3%, depending on the study population.

The TGA notes that it is difficult to compare the study populations cited by the FDA to the Australian population to determine if the expected rate of underlying malignancy is similar.

The nine studies included in the FDA's primary analysis were conducted in five different countries with differing healthcare systems and little information is available regarding patient demographics. This is of importance as women of African descent have an increased prevalence of uterine fibroids and an earlier age at diagnosis when compared to women of Asian or Caucasian descent.¹ Five of the nine studies included in the FDA analysis were conducted in the USA where a sizeable proportion of the population is African-American. None of the studies used to generate the FDA risk estimate was conducted in Australia.

The FDA risk estimate that 1 in 350 women undergoing surgery for uterine fibroids had an underlying malignancy is not reflected in the known data which suggests that the rate is much lower in an Australian population.

Relative to the FDA risk estimate and based on the limited and indicative Australian data available, the likely risk in the Australian population may be approximately three times lower than in the US population (i.e. approximately 1 in 1000). This is also considered the maximum likely rate. The actual rate is anticipated to be even lower. Additionally, the rate for LMS would be much lower than the rate of uterine sarcoma.

Reference

1. Review Article: Mechanisms of Disease - Uterine Fibroids. DL Longo (Editor) and SE Bulun, N Engl J Med 2013; 369:1344-55

TGA reviewing Instructions for Use

The TGA is reviewing the Instructions for Use (IFUs) for these devices to ensure they:

• include comprehensive details of the risks posed
• specify that sponsors are required to ensure all users are appropriately credentialed and trained in the use of the devices
• reinforce the need for surgeons to have an appropriate informed patient consent process.
• include 'suspected uterine tumour' as a contraindication.

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.