Johns Hopkins Sets Protocol to Limit Risk of Morcellation and Uterine Cancer
Johns Hopkins University recently announced their decision to discontinue use of power morecellators for some types of surgical procedures in women over the age of 50. The decision was made in hopes of reducing the risk of morcellation and uterine cancer, a concern that has come to the forefront of the gynecology industry in light of adverse event reports and lawsuits filed against morcellator manufacturers.
The noted teaching hospital has also stopped using morcellators for surgeries involving women that have other risk factors for uterine cancer. These factors include hereditary cancer syndromes, pelvic radiation, BRCA mutations and use of the drug tamoxifen.
“Given the review of our institutional data and recent national debate surrounding power morcellation, our institution developed the protocol to enhance safety for women [undergoing] minimally invasive surgery for benign indications,” Dr. Stephanie Ricci, a gynecologic oncology fellow at Johns Hopkins stated to The Oncology Report.
Other organizations offer similar guidelines regarding power morcellators
The protocol was announced by Johns Hopkins just a few days before the FDA posted similar recommendations. On November 24, the agency issued a safety communication stating use of power morcellators in peri- or postmenopausal women is contraindicated for removal of fibroids or suspected cancerous tissue. They also urge healthcare providers to consider all the treatment options available for women with uterine fibroids.
The Society of Gynecologic Oncology has also taken a position on power morcellators, stating the devices should not be used when a malignancy is suspected or documented. The society also believes the morcellator device to be ill-advised in cases where the patient is being treated for a pre-malignant condition. The SGO also advises healthcare providers to look at all possible treatment options and thoroughly discuss the risks and benefits of each procedure with the patient.
Power morcellation and uterine cancer
Power morcellators are medical devices used to break up tissue before removing it from the uterus. The device allows for a much smaller incision and subsequent scarring, which is why it has become a popular option during hysterectomy and myomectomy procedures. However, reports that the morcellator can spread cancerous tissue to other areas of the body during the procedure has raised serious concerns among providers and patients.
Johns Hopkins recent guidelines primarily target “occult malignancies,” which are cancers that have spread without a known source. In a review led by Dr. Ricci that looked at patients treated with power morcellation between 2005 and 2014, two occult malignancies were detected in 424 patients. While the number seems low, the problem can be very serious. When cancer cells are spread in this manner, they can evolve into a deadly type of cancer known as uterine sarcoma.
Uterine sarcoma is a very difficult cancer to treat completely. Reports of deaths from this type of cancer after use of power morcellators have been reported. Other women have gone through long and painful bouts of cancer treatment in an effort to eradicate the cancer cells. The cost of the process can be large, and the emotional and physical toll it takes on the patient is beyond value.
New recommendations by both Johns Hopkins University and the FDA underscore the risks associated with power morcellators. While these new guidelines may not help those already injured by the devices, there is hope that fewer women will be exposed to those risks in the future. In the meantime, many women that have been injured as a result of these devices are now filing lawsuits in courts across the country, seeking damages for pain and suffering, medical expenses and other non-economic losses.
- The Oncology Report, Hopkins Protocol Aims to Limit Sarcoma Morcellation Risk, http://www.oncologypractice.com/the-oncology-report/home/article/hopkins-protocol-aims-to-limit-sarcoma-morcellation-risk/9427131fe345645bbc91fecbc9b5859a.html
- FDA, UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm
- Med Page Today, Study Quantifies Cancer Risk of Morcellation, http://www.medpagetoday.com/HematologyOncology/OtherCancers/46907
- Society of Gynecologic Oncology, SGO Position Statement: Morcellation, https://www.sgo.org/newsroom/position-statements-2/morcellation/