FDA Recommends More Morcellator Restrictions

To reduce the risk of spreading undetected cancer, the FDA has issued stricter guidance on the use of power morcellators in certain gynecological surgeries.

The guidance, which follows a similar warning in April, goes into effect immediately. It advises physicians not to use power morcellators to remove the uterus (hysterectomy) or uterine fibroids (myomectomy) from patients who are peri- or post-menopausal, or are candidates for removing tissue intact through the vagina or a minilaparotomy incision.

Morcellation is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites by dividing it into smaller pieces or fragments. The problem with the procedure is that cutting a tumor into fragments can make it difficult to remove all of the tumor tissue. In addition, small tumor fragments can be seeded throughout the body, leaving the patient in many cases with multiple tumors.

To avoid such outcomes, FDA also advised against using the devices in gynecologic surgery on known or suspected malignant tissue. Physicians should also advise their patients on the risks of power morcellation, according to the FDA.

The agency also advised manufacturers to add warnings about the dangers of using power morcellators in most hysterectomy and myomectomy patients, including the two contraindications for the devices, according to its statement. It also advised physicians to share the boxed warnings with patients. The guidance is available online. 

Some younger women who want to have children or wish to keep their uterus intact after being informed of the risks may be candidates for power morcellation, the FDA added.

Other surgical treatment options available for women with symptomatic uterine fibroids include traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, and laparotomy using a smaller incision (minilaparotomy).

The FDA estimates that 1 in 350 women undergoing either procedure to treat fibroids has an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. There is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma, the agency said.

"If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's long-term survival," the FDA statement said. "While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood."

The new guidance applies to currently marketed and new laparoscopic power morcellators for general and specific gynecological indications.

In April, Johnson & Johnson announced a sales suspension that included the Gynecare Morcellex Tissue Morcellator, Morcellex Sigma Tissue Morcellator System and the Gynecare X-tract Tissue Morcellator. Three months later, the company's Ethicon subsidiary pulled all of its power morcellators from the market.

The issues surrounding the morcellators have not only effected the companies that make them, such as Ethicon, but also companies such as Intuitive Surgical, which makes surgical robots for the early stages of hysterectomies, before morcellation takes place.

Nancy Crotti is a contributor to Qmed and MPMN.

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