Several hospitals and health insurance companies have decided not to cover a procedure intended to treat uterine fibroids because of its suspected risk of spreading cancer. One of those firms, Aetna, partially backed out Tuesday, insisting that doctors take an approval step before they perform the operation.
The procedure is known as laparoscopic power morcellation. It involves the surgeon's use of a medical device while removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). The device divides tissue into smaller pieces or fragments so that they can be removed through small incision sites. Device manufacturers have been taken to court by victims and by the families of decedents who allege that power morcellation resulted in a cancer diagnosis.
"Aetna is implementing a new policy on the use of power morcellation in the removal of uterine fibroids," the corporation wrote in a May 5 statement. "Myomectomy and hysterectomy procedures that use a power morcellator will not be covered in most circumstances because the safety and efficacy of this approach has not been demonstrated. Aetna will require doctors to precertify myomectomies or hysterectomies that use a power morcellator."
Aetna placed as many as two preconditions on physicians that must be met in order to receive a "clinical exception" and to have the procedure covered. These bullets are straight from Aetna:
- The patient is pre-menopausal, wants to maintain her fertility and another surgical or non-surgical fibroid treatment wouldn't be effective; and/or
- The patient has severe comorbidities where the risk of death or severe morbidity of another procedure outweighs the risk of an undiagnosed sarcoma.
As power morcellation lawsuits began to be filed in 2014, members of Congress began to pressure the U.S. Food and Drug Administration to take prompt action in the interest of public health.
For instance, U.S. Sen. Charles Schumer and U.S. Sen. Kirsten Gillibrand, both from New York, sent a letter to the FDA in August 2014 that pointed out a power morcellator manufacturer's recall and requested that the agency stimulate similar withdrawals. A part of their joint letter reads, "Johnson & Johnson's Ethicon division, the leading manufacturer of morcellation equipment, promptly withdrew their products from the market. ... [W]e urge the FDA to request that other manufacturers of laparoscopic morcellation devices withdraw their equipment from the market until additional risk assessments and patient and clinician education can be performed."
About two months later, U.S. Sen. Robert Casey of Pennsylvania urged the FDA to hastily and thoroughly probe the health concerns that his constituents and many others have raised.
"I understand that FDA has recently issued a safety communication discouraging the use of laparoscopic power morcellation, and intends to consider the safety of these devices further," Casey wrote in his October 2014 letter to the FDA. "Given the widespread use of these devices and the seriousness of the claims made against these products, I urge the FDA to swiftly and closely evaluate the concerns that have been raised, and take any additional action necessary that is appropriate to safeguard the health of the public."
If the senators' prodding did not sway the FDA, then the agency's examination of recent data surely did. The FDA issued stronger language against laparoscopic power morcellation after it received the senators' correspondence.
In April 2014, the FDA wrote that it "...discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids." But in November 2014, the FDA ramped up "discourages" to a full-blown stop sign, writing "...the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids."
The agency has maintained since April that the adverse event data was alarming. In a 2014 statement, the FDA explained, "Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma. 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."
Women who received their cancer diagnosis after receiving a hysterectomy or a myomectomy by laparoscopic power morcellation may want to discuss their legal options with an attorney. The experienced product liability attorneys at Reich & Binstock evaluate these cases free of charge to determine whether there is an entitlement to compensation.
For a free consultation, contact Reich & Binstock either by calling the toll-free number, 1-866-LAW-2400, or by submitting an electronic message through this web page.