Increasing Evidence that Use of Devices Could Spread Uterine Cancer / FDA Has Issued Warnings and Leading Manufacturer Has Suspended Sales
Washington DC- Today, U.S. Senator Bob Casey (D-PA) announced that he has sent a letter to Karen Ignagni, President of America’s Health Insurance Plans (AHIP), pressing the trade group on ways in which insurers can work with other stakeholders to protect patients from potentially dangerous power morcellators. There is increasing evidence that the use of power morcellators during hysterectomies to treat uterine fibroids (an otherwise benign condition) can spread certain types of uterine cancer, known as sarcomas, throughout the abdomen during surgery. While women are examined and tested for potential uterine cancers before such surgery, some sarcomas simply cannot be detected. By spreading the cancer beyond the uterus, the procedure can dramatically advance the stage of the cancer, and significantly reduces the patient’s chance of surviving the cancer.
“The increasing reports about the potential dangers from power morcellators are troubling and raise serious questions about this device,” Senator Casey said. “It’s incumbent upon a major trade group like AHIP to ensure that insurers are aware of the potential dangers and are taking appropriate steps to protect patient health.”
Dear Ms. Ignagni:
I write today to inquire about the medical device known as the power morcellator. There is increasing evidence that the use of these devices during hysterectomies to treat uterine fibroids (an otherwise benign condition) can spread certain types of uterine cancer, known as sarcomas, throughout the abdomen during surgery. While women are examined and tested for potential uterine cancers before such surgery, some sarcomas simply cannot be detected. By spreading the cancer beyond the uterus, the procedure can dramatically advance the stage of the cancer, and significantly reduces the patient’s chance of surviving the cancer.
As evidence has built indicating potential dangers of morcellators, the FDA and some in industry have responded. In April of last year, Johnson & Johnson, the leading manufacturer of these devices, suspended sales of new morcellators; in July, the company recalled existing devices. Also in April, the FDA issued a safety communication to the medical community discouraging the use of morcellators during hysterectomies. In November, the agency updated the safety communication and warned “against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.” The agency also strongly urged manufacturers to update their device labels to reflect the new warnings.
In recent months, at least two insurers (Highmark and UnitedHealth) have implemented policies intended to restrict the use of these devices. Given this increased concern regarding the safety of morcellators when used in gynecologic procedures, I have several questions for your health insurance trade association:
- In September 2014, Highmark announced it would halt coverage of laparoscopic uterine power morcellation in its benefit plans. Have any other health insurers stopped covering gynecologic procedures using these devices?
- Citing the FDA’s warning about the risks associated with power morcellators and medical evidence in favor of vaginal surgery, UnitedHealth recently announced it will require physicians to get authorization before performing most types of hysterectomy. Are you aware of any other insurers considering similar restrictions?
- In May 2014, the American Congress of Obstetricians and Gynecologists (ACOG) issued a report that recommends implementation of physician credentialing processes to promote a continual focus on training, including techniques for morcellation, inspecting for tissue fragments after morcellation is performed; and on determining when morcellation is considered an appropriate therapeutic option. Do any insurers require physician credentialing in the use of power morcellators as a condition for reimbursement?
- Do any health insurers collect claims data to assist in linking adverse events to medical devices? In particular, have any of them analyzed adverse events due to the use of power morcellators in gynecologic surgery?
- Although power morcellation is most often used in gynecologic surgery, it is also used in other surgical specialties such as urology (for the performance of nephrectomies and prostatectomies) and general surgery (for the performance of splenectomies). Do any health insurers collect morcellator adverse event data for these procedures?
- Because the data on preoperatively undiagnosed uterine sarcoma is inadequate, ACOG has called on the FDA to develop a national prospective morcellation surgery registry to collect data on morcellator product safety. How, potentially, could health insurers collaborate with the FDA on such a registry?
I would appreciate a timely response to these questions. If my office can be of further assistance, please do not hesitate to contact my staff at 202-224-6324.
Robert P. Casey, Jr.
United States Senator