The TGA's Urogynaecological Devices Working Group ( UDWG ) has provided advice following a safety communication published by the US Food and Drug Administration ( FDA ) 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.
Laparoscopic morcellators are devices used to cut tissue into smaller pieces to aid removal during minimally invasive 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.
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. A
GES-RANZCOG noted that the true incidence of leiomyosarcoma in the general population in Australia is unknown and there has been no evidence of any leiomyosarcoma cases occurring post-morcellation in Australia.
The TGA has noted 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.
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 leiomyosarcoma would be much lower than the rate of uterine sarcoma.
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. ( Xagena )
Source: TGA ( Therapeutic Goods Administration ), 2014