Johns Hopkins’ New Rules Severely Limit Power Morcellator Use Amid Cancer Risk
Officials at Johns Hopkins Hospital in Baltimore indicate that they will no longer use morcellation to remove uterine fibroids or to conduct laparoscopic hysterectomies for women over 50, due to the risk that power morcellators may spread uterine cancer.
The prestigious hospital made the announcement at a recent American Association of Gynecologic Laparoscopists (AAGL) conference, according to a December 10 report in The Oncology Report. The hospital made the policy change after two occult malignancies, both involving women over the age of 50.
Researchers at Johns Hopkins University conducted a review of 424 uterine morcellation cases over the last nine years.
Power morcellators are medical devices used during laparoscopic hysterectomy and myomectomy procedures, allowing the surgeon to cut up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The tool facilitates a minimally invasive surgery, which reduces recovery time, minimizes scarring and helps avoid many of the risks associated with traditional surgery.
Over the past year, concerns have emerged over the risks associated with the morcellators, as they may cause unsuspected sarcoma contained within the uterus to be spread throughout the body, rapidly upstaging aggressive uterine cancers.
As a result of estimates that suggest up to one in 350 women undergoing a laparoscopic hyesterecomy or fibroid removal may have this unsuspected uterine cancer, which doctors are unable to detect or diagnose before the procedure, many health experts have called for laparoscopic morcellator recalls to be issued.
Johns Hopkins’ new protocols contraindicate morcellation for women who have other risk factors for gynecologic cancer, such as the use of the breast cancer drug tamoxifen, pelvic radiation hereditary cancer concerns, and other factors. When women do qualify for power morcellation procedures for hysterectomies and uterine fibroid removal, the hospital now mandates that such surgeries be conducted by experienced surgeons who also use endoscopy bags to catch debris made by the morcellation procedure.
The hospital updated its protocols just before the FDA issued new power morcellator black box warnings and contraindicated the devices for most women who would undergo the procedure.
Johns Hopkins joins a growing number of hospitals and insurance companies who have turned away from the procedure due to the concerns that it can upstage undiagnosed uterine sarcoma and leiomyosarcoma.
Uterine Fibroid Morcellator Cancer Risks
Concerns about the risk of uterine fibroid morcellators disseminating cancer have gained widespread attention in the medical community over the past year.
In April 2014, the FDA urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures due to the cancer risks and convened an FDA advisory panel meeting over the summer to evaluate the available data on the safety of the devices.
The panel of independent advisors to the FDA concluded that there was no way to make morcellators safer, but was split on whether to recommend a recall or stronger warnings.
In recent months, a growing number of women and families nationwide have been filing uterine fibroid morcellator cancer lawsuits against the manufacturers of these devices, alleging that inadequate warnings have ben provided for patients and the medical community for years.
Plaintiffs allege that the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.