News
The Ethicon letter states that the discussion during the meeting "demonstrated the complexity of this issue, particularly with respect to the difficulty for medical professionals to preoperatively diagnose some malignancies, such as leiomyosarcoma ... [and] the risk of disseminating unsuspected malignant tissue while using power morcellation devices," as well as methods to mitigate this risk.
But to date, Ethicon, a Johnson & Johnson company, is the only manufacturer of morcellation devices used in gynecology to suspend and withdraw its products. There are five other manufacturers or distributors of LPMs with gynecologic indications that have been marketed in the past year, according to the FDA.
Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview that he views the Ethicon move to withdraw all morcellation devices as a business decision. This "may be the first domino to fall," and whether competing manufacturers of morcellation devices also decide to withdraw their products or choose an alternative path "remains to be seen."
At the Einstein health care network in Philadelphia, there is currently a moratorium prohibiting the use of power morcellation in gynecologic surgery, while a standard acceptable counseling form is being developed. Dr. Jaspan is working with robotic and minimally invasive surgeons "to create a document that we feel will provide patients with transparency, alternatives, and choice," he noted.
As a result of the FDA’s safety announcement, there has been an increase in open procedures for fibroids in patients who would have been "excellent candidates" for a robotic procedure; did not have a sarcoma; and would have avoided a prolonged length of stay, time away from work, delay in activities of daily living, more blood loss, and pain, he said.
But the FDA estimates that among women who undergo a hysterectomy or myomectomy for a presumed fibroid, about 1 in 350 has a uterine sarcoma, and about 1 in 500 has an LMS. Dr. Jaspan is among those who believe this is an overestimate.
Dr. Jaspan had no disclosures.
Ethicon can be contacted at 877-384-4266 for more information. Adverse events related to LPMs or other medical devices should be reported to the FDA at 800-332-1088 or here.
