In the fallout of an FDA advisory that warned of risks tied to a surgical procedure to remove uterine growths, patients and providers remain torn over the safety and efficacy of related devices.
Last month, the FDA issued a warning against using laparoscopic "power morcellator" devices in minimally invasive surgeries to remove uterine fibroids. The agency said that women undergoing the procedures carried a 1 in 350 risk of uterine sarcoma, and that morcellator tools could worsen the spread of cancerous tissue. Prior to the advisory, the device was used in an estimated 50,000 U.S. uterine surgeries each year, The Wall Street Journal reports.
While many hospitals and physicians have heeded the FDA's warning, some providers are taking a more measured approach. Allen Hogge, chairman of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh Medical Center system, questioned the agency's data, saying that the reports were "mostly public relations and not science," according to the WSJ. Duke University Health System also opted to continue use of the power morcellator after obtaining patient consent.
Other providers like Orlando-based Florida Hospital have completely suspended their use of morcellator products. "There [were] very strong emotions on all sides of the fence and a lot of people quite frankly upset with the FDA's warning," Neil Finkler, the hospital's chief medical officer and a gynecologic oncologist, told The Wall Street Journal. Finkler said that he treated two patients who died from sarcomas after undergoing morcellation procedures performed by other doctors, and that he agreed with the FDA's guidance.
The industry, for its part, has also responded to the FDA's qualms. Weeks after the agency issued its advisory, Johnson & Johnson ($JNJ) suspended sales of power morcellator devices made by its Ethicon unit. In April, Intuitive Surgical ($ISRG) cut 2014 growth projections for its da Vinci surgical system from as much as 12% to as little as 2%, citing power morcellator safety concerns as one of the main factors in its lowered guidance. The company issued a recall of 1,300 of its da Vinci devices in November.
Earlier this month, Boston Scientific ($BSX) shelled out $65 million for IoGyn, a California startup that develops products for minimally invasive gynecological surgery. Through the deal, the company will gain access to IoGyn's Symphion system, an alternative to traditional morcellation tools that resects growth within the uterus and removes tissues using suction. Boston Scientific will pair the device with its own Genesys HTA system for abnormal uterine bleeding to strengthen its gynecological surgery portfolio, the company said in a statement.
- read the WSJ article (sub. req.)