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| Johnson & Johnson suspended sales of its Ethicon morcellation devices in April. |
Power morcellator manufacturers could soon face a new wave of regulatory scrutiny, as the FDA will convene in July to hash out previous safety advisory warnings and set its recommendations for the device's future use.
The agency will hold a Medical Device Advisory Committee on July 10-11 to discuss the safety of laparoscopic power morcellator devices in minimally invasive surgeries to remove uterine fibroids, and to determine how the tools should be labeled, tested and used in clinical settings, according to a Federal Register notice. The meeting follows on the heels of early regulatory action, as the FDA issued a warning in April that advised against use of the devices to remove uterine fibroids. The agency said that women undergoing the procedures carried a one in 350 risk of uterine sarcoma, and that power morcellators could worsen the spread of cancerous tissue.
Prior to the FDA's advisory, the device was used in an estimated 50,000 U.S. uterine surgeries each year, The Wall Street Journal reported.
Sterne Agee analyst Gregory Chodaczek predicted the FDA will likely issue a "boxed warning" at its July committee meeting, making it mandatory that hospitals and doctors discuss potential risks associated with power morcellator devices. Chodaczek does not think the agency has enough data to issue a recall or ban the product, he wrote in an analyst report.
The upcoming meeting could hold negative implications for power morcellator devicemakers, as companies are still trying to recoup after the recent regulatory backlash. Weeks after the FDA issued its warning, Johnson & Johnson ($JNJ) suspended sales of morcellator devices made by its Ethicon subsidiary. The country's largest morcellator maker said it would not take its devices off the market, but would instead temporarily halt sales.
"This decision was not made lightly because we are well aware of the significant benefits that these products can offer many women," J&J wrote in its letter to customers, according to the WSJ. "Since 1998, Ethicon's morcellation devices have enabled thousands of patients to have minimally invasive surgical hysterectomy and myomectomy procedures, instead of more-invasive surgical procedures."
In April, Intuitive Surgical ($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. The company issued a recall of 1,300 of its da Vinci device arms in November.
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 Federal Register notice
- get more from The Wall Street Journal (sub. req.)