|Johnson & Johnson suspended sales of its Ethicon morcellation devices in April.|
After months of warnings and a debate over the safety of laparoscopic power morcellators, the FDA begins its formal decision making process July 10, when the Obstetrics and Gynecology Devices Advisory Committee convenes for two days in what will be one of the agency's most prominent meetings of the year.
Power morcellators are surgical drills used to remove fibroids during some hysterectomy or myomectomy surgeries. In 2010, 498,000 hysterectomies were performed in the U.S., according to an executive summary on the use of power morcellators during uterine surgery that was prepared for the meeting.
Soon after the FDA issued its safety warning, Johnson & Johnson's Ethicon unit announced that it was temporarily halting sales of its power morcellators.
The FDA says that about one in 350 women who undergo hysterectomy or myomectomy to removes fibroids unknowingly have uterine sarcoma, a type of uterine cancer, and one in 498 have uterine leiomyosarcoma, another cancer. The agency acknowledges that the estimate is higher than other published estimates.
According to the executive summary, the panel will discuss the risks and benefits of power morcellation; possible techniques to improve the safety and effectiveness of the procedure, such as the use of specimen bags; and whether labeling about the risk of cancer should be required for the devices.
Given the agency's stern warnings and industry reaction, action is likely, and a change to labeling is almost guaranteed. Currently, power morcellators require a 510(k) for marketing approval; upgrading the instruments to Class III devices requiring a PMA is another possibility. Advisory panels' recommendations are not binding, but they usually prove influential.
The agency explained how the 1:350 ratio was derived in the executive summary. The FDA said that it reviewed 8 studies and one abstract to arrive at the estimate. Further refinements were made using a statistical model that took into account differences among the individual studies.
Furthermore, the FDA says that following morcellation, about 25% to 65% of the unsuspected sarcomas are "upstaged" to a higher level using the classification guidelines developed by the International Federation of Gynecology and Obstetrics. By "seeding" sarcomas beyond the uterus, power morcellation could lead to cancer recurrence and a lower chance of survival, the FDA says.
Judging by the industry's strong reaction so far, companies are taking the FDA's concerns seriously and expect change. In April, Intuitive Surgical ($ISRG) cut 2014 growth projections for its da Vinci surgical robot from as much as 12% to as little as 2%, citing power morcellator safety concerns for gynecological procedures as one reason behind its lowered guidance. According to the executive summary, robotic surgical equipment was used in 9.5% of hysterectomies in 2010, up from 0.5% in 2007.
Other companies like Boston Scientific ($BSX) are taking a different route and investing in alternative therapies. The Massachusetts device giant shelled out $65 million last month for a 72% stake in IoGyn, a California startup that develops products for minimally invasive gynecological surgery. Boston Scientific plans on pairing IoGyn's Symphion system with its own Genesys HTA system for abnormal uterine bleeding to strengthen its gynecological portfolio, the company said in an earlier statement.
- read the FDA's preview materials