Two new studies have cast further doubt on the safety of using the medical device, laparoscopic power morcellators, during hysterectomies and myomectomies.
A study by University of Michigan scientists published in the journal Obstetrics & Gynecology has reported that one in 368 women who undergo hysterectomies due to fibroid growths in the uterus have an undetected uterine sarcoma. The study, which reviewed 2,575 women in 2013, concluded that use of a morcellator could worsen the sarcoma.
The Journal of the American Medical Association Oncology has published a new study online finding that in procedures where surgeons use morcellators in myomectomies, in which only the fibroids are removed, the risk that women have undetected cancers is lower than in hysterectomy patients. With age, however, the risk of undetected cancer increases even for women facing fibroid removal only. Younger women still hoping to bear children often opt for a myomectomy rather than a hysterectomy.
Risk of Morcellator Use Increases with Age of Patients, Leading Hospitals to Ban Morcellator Use
In November 2014, the FDA warned of the risks involved with using a power morcellator to remove the uterus or fibroids via small incisions below the pubic hairline. If undetected cancers are present, use of the morcellator can spread cancer cells around in the body. Johnson & Johnson has stopped making the morcellator altogether and many hospitals have limited morcellator use. Temple University Hospital, for example, says the risk is too great.
One difficulty with morcellator use is that prior to surgery, doctors cannot distinguish reliably between a benign fibroid and a uterine sarcoma. Physicians not connected with the two latest studies are reportedly carefully watching the emerging research.
The JAMA Oncology study found that in myomectomy patients on whom morcellators were used, the risk of undetected uterine cancer was 1-in-1,073 as opposed to the much higher 1-in-10,000 rate that doctors used to say existed before the FDA’s warning about power morcellators focused attention on the issue. The JAMA Oncology study included both the aggressive sarcomas and the endometrial cancers that some say may be more easily detected prior to surgery.
Waters Kraus & Paul: Learn More about Filing a Morcellator Lawsuit
Waters Kraus & Paul enjoys a national reputation and a wealth of experience representing clients injured by dangerous products and unsafe medical devices, such as power morcellators. We understand that injuries caused by power morcellators are personal and they’re sensitive. That’s why we’ve assembled a legal team, most of whom are women, to provide our morcellator clients with compassionate and aggressive representation throughout the entire course of litigation.
Based in Dallas, Texas, with offices in California and Maryland, Waters Kraus & Paul has participated in the representation of families from all fifty states and many foreign countries, as well as foreign governments.
To learn more about Waters Kraus & Paul, or to have one of our attorneys review your potential morcellator case, contact us by email or call our morcellator lawyers, like Kyla Cole in our Texas office, at 800.226.9880.