Warning against complications led to a rise in complications

Patient-Reported Outcomes 

An FDA warning against power morcellation of uterine fibroids caused an increase in abdominal surgery and increased rates of postoperative complications.

In November 2014, the US FDA issued a warning against power morcellation of uterine fibroids in conjunction with laparoscopic hysterectomy. The main concern was that unprotected morcellation within the pelvic cavity may lead to spillage of tumour cells in the context of uterine cancer. The majority of leiomyosarcomas are diagnosed incidentally and unexpectedly.

As a consequence, hospitals had limited the use of power morcellators and US health insurance providers had declined to reimburse gynaecologists for laparoscopic hysterectomy.  Reimbursement was limited to vaginal or open hysterectomy.

The paper published in April 2018 examines the consequences of that FDA warning on patient outcomes. Using a large US database on surgical outcomes (NSQIP), the primary study endpoint was 30-day hysterectomy complications.

The authors compared complication rates before the FDA warning with complication rates after the FDA warning.

Of a total of 75,000 women who had a hysterectomy, 25,000 women had a hysterectomy for uterine fibroids. Only in this group a difference in surgical complication rates was seen.

  1. Major complication rates increased by 23% after the FDA warning;
  2. Minor complication rates increased by 21%;
  3. Laparoscopic hysterectomy decreased from 56% to 49% since the FDA warning.

In hindsight, the FDA should have assisted gynaecologists to manage the risk of tumour spillage rather than simply create conditions that avoid laparoscopic hysterectomy.

Learning points:

  1. Uterine sarcomas are hardly diagnosed preoperatively;
  2. Spillage of specimen should always be avoided even if a benign condition is assumed
    1. Free, unprotected (power) morcellation at laparoscopic, vaginal or open hysterectomy;
  3. Don’t offer myomectomy to postmenopausal women;
  4. Use a containment bag to secure the specimen and morcellate only within the confinements of a containment bag;
  5. Record your outcomes of unexpected malignancy at gynaecological surgery and check that you are within the expected boundaries.