|Ethicon's Morcellex Sigma Tissue Morcellator--Courtesy of Johnson & Johnson|
Months after the FDA strengthened its warning against using laparoscopic power morcellator tools for the "majority" of women undergoing minimally invasive gynecological procedures, a new study shows that healthcare providers are turning to different surgical methods that do not require the device.
As The Wall Street Journal reports, Yale University researchers interviewed 43 high-volume minimally invasive gynecologists and fellowship faculty members at large U.S. teaching hospitals, and found that 78% of physicians changed their clinical practice after the FDA issued its updated warning. Doctors instead are choosing "mini-laparotomy" procedures in which the uterus is removed through a small incision above the pubic bone, or traditional abdominal hysterectomies, which is one of the most common methods of the procedure. Researchers will publish their findings in the American Journal of Obstetrics & Gynecology in May.
Open hysterectomies and laparoscopic surgeries each come with their own set of challenges, as open procedures often lead to longer hospital stays, more blood loss, higher infection risk and longer recovery time, while laparoscopic procedures can be lengthy and raise the risk of urinary-tract injuries, the WSJ reports. But the FDA said last year that more studies still need to be done to compare the risk of death from power morcellation to open surgery.
And not all physicians are on board with the FDA's updated guidance. The agency advised in November that manufacturers add boxed warnings and two contraindications for the devices in their product labels, informing patients and providers about morcellator risks. Regulators also recommended that power morcellators should not be used in older women or patients who could have tissue removed intact through the vagina or a mini-laparotomy incision.
But Allan Katz, chief gynecologist at Memorial Hermann-Texas Medical Center in Houston, told the WSJ he disagrees with the FDA's warning and that his hospital is seeing more open surgeries since it banned the morcellator a year ago. "Now (patients) have a big incision and the recovery takes a little bit longer and the pain is higher," Katz said. He added that he expects fewer open surgeries as doctors turn to minimally invasive procedures.
Meanwhile, the industry continues to respond to public backlash against the devices, which were once used in an estimated 50,000 U.S. uterine surgeries each year. In July 2014, Johnson & Johnson ($JNJ), the largest U.S. manufacturer of the devices, pulled its related devices from the market. Last month, UnitedHealth Group ($UNH) announced that as of April it would require doctors to get prior authorization from the insurer before performing most kinds of hysterectomies, including those with power morcellator tools.
"We need to do more on behalf of our members to ensure that they would get the safest and most effective method" of hysterectomy, said Sam Ho, UnitedHealth's chief medical officer.
- read the WSJ story (sub. req.)