Morcellation in Surgical Gynaecology

Tagged Morcellation, FDA, TGA, myomectomy, uterine sarcoma; Comments 5 ; Posted 11 years ago

A few weeks ago the U.S. FDA issued a Safety Alert and recommended that power morcellators be not used for gynaecological procedures such as myomectomy or laparoscopic hysterectomy. A coiuple of weeks ago, Johnson and Johnson/Ethicon withdrew their entire product range of power morcellators from the market.

The Australian TGA also followed with an alert on the risks of power morcellation and in a knee-jerk reaction some Australian hospitals apparently took power morcellators off their shelves entirely to comply with the U.S. FDA recommendation.

By contrast, professional gynaecological standard bodies and professional societies, including AAGL, AGES and RANZCOG reacted in a far more balanced way and AAGL even released a supportive statement for the continued use of morcellators. AGES and RANZCOG guidelines will be released shortly.

I am hoping to assist with some information that will allow gynaecologists to continue the use of power morcellators for the benefits of a large number of patients. 

Background

Recently, cases were reported where morcellators have been used to retrieve an enlarged uterus during laparoscopic hysterectomy where the histopathology report unfortunately confirmed the presence of a uterine sarcoma. During these cases, tumour spread into the abdominal cavity was observed, which is very concerning. We need to assume that tumour cell spillage of uterine sarcomas significantly worsens the patient’s prognosis.

Specifically, the discussion is about uterine leiomyosarcomas (LMS). These are rare, aggressive uterine cancers that are very difficult to be diagnosed preoperatively. These tumours may maintain an intact endometrial lining and often are not detected by endometrial sampling or curette. Warning signs include a large pelvic or uterine mass in postmenopausal woman; occasionally a patient reports a rapidly growing uterus.

LMS are highly aggressive, mesenchymal malignancies arising from the myometrium and not involving the endometrium. A reliable diagnosis can only be made at histopathology once the specimen has been removed. Even then, a differential diagnosis between various forms of mesenchymal tumours is sometimes difficult.

Treatment of LMS is surgical removal of all tumour tissue. If surgery is unsuccessful or tissue remains in the abdominal cavity, prognosis is poor. Radiation treatment or chemotherapy is not effective in LMS. Relevant to our above scenario tumour spill is unlikely to be salvaged or successfully treated by postoperative radiation or chemotherapy treatment.

By contrast, uterine fibroids are extremely common and most women will develop uterine fibroids at some point in their lives. While various treatment options have been evaluated, hysterectomy is the most effective option for those women who tried medical treatment unsuccessfully in the past or who completed their family. Approximately 30,000 women have a hysterectomy in Australia every year and the majority of these procedures are performed to treat non-cancerous conditions, such as uterine fibroids or adenomyosis. Laparoscopic hysterectomy should be the standard if a vaginal hysterectomy is infeasible; abdominal hysterectomy should be reserved for special circumstances and should not be performed on a routine basis.

The FDA has estimated that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have LMS. If laparoscopic power morcellation would be performed in these women, there would be a significant risk that the procedure will spread cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.

These US data are not supported by Australian data and appear inflated. At the Queensland Centre for Gynaecological Cancer (QCGC) we operate on virtually all patients with uterine malignancies in Queensland. Only a very small minority of uterine cancer cases are treated outside a QCGC institution.

In 2010 we recorded 8 cases of LMS and in 2011 there were 5 cases of LMS recorded. Given that 6,000 women have a hysterectomy every year in Queensland, the risk of an inadvertent finding of a LMS is 0.001 per cent – or 1 in a thousand.

Typically, as gynaecological oncologists we are contacted when an endometrial cancer has been found incidentally and unfortunately has been morcellated. This is a very problematic situation also requiring the patient to undergo additional surgical exploration. In addition, we would offer the patient chemotherapy plus radiation postoperatively, even if we are aware that the chances to respond th=o this treatment is not great. All this would hardly ever be required if we knew about the existence of the endometrial cancer in advance.

However and from personal experience, as QCGC surgeons we have hardly ever been contacted because of a morcellation of LMS in the past few years.

I do agree with the FDA that a diagnosis of LMS cannot be excluded 100% in all patients undergoing hysterectomy prior to surgery. Unfortunately, LMS is not limited to a certain age group but in our three-year series we found only one patient younger than 40 years of age with LMS. The majority of LMS affect postmenopausal women.

However, the risk of an inadvertent finding of LMS is low and with some additional caution can be further decreased.

What can we do as gynaecological surgeons to minimise the risk of inadvertently spreading LMS?

1. Avoid morcellation of a large uterus in postmenopausal women. The risk of malignancy in postmenopausal women is many times higher than in premenopausal women.
   1. Risk factors for malignancy include large size, tissue signal heterogeneity, central necrosis and ill-defined margins, as well as ascites and lymph node enlargement.
   2. A significantly enlarged uterus in a postmenopausal woman is highly abnormal and should trigger a consideration for a gynaecological oncology referral.
   3. Like any ovarian masses, suspicious or not, need to be removed without spillage through an endocatch bag to minimise the risk of dissemination. Removing masses without endocatch bag will subject the patient to advanced stage cancer necessitating chemotherapy in the unlikely event of a malignancy.
2. In women with a very large fibroid arrange for additional medical imaging, such as a pelvic MRI. While not 100% reliable, fibroids as well as adenomyosis will have very distinctive signal intensity.
3. Tumour markers will be not helpful in this particular seting to differentiate between LMS and benign uterine tumours.
4. Preoperative biopsies masses of adnexal or uterine should not be performed. Mesenchymal tumours of the uterus are heterogeneous and those biopsies would either increase the risk of tumour spillage and if negative, could not be relied upon.
5. It is generally accepted that all women with an abnormal (postmenopausal) bleed should have a hysteroscopy D&C. I would recommend the same for those with a significantly enlarged uterus for unknown reasons or secondary to cervical stenosis.

In doubt, ask a gynaecological oncologist for advice. You can always email a brief summary as well as medical imaging and receive an obligation-free opinion.

Should a general gynaecologist come across an unexpected finding of a suspicious mass at surgery, please call a gynaecological oncologist immediately while the patient is still under anaesthetic. We will be able to advise about the next best steps in order to avoid long-lasting damage to the patient.

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