A Pennsylvania researcher has been awarded the opportunity to build a new power morcellator aimed at preventing the spread of uterine cancer, a side effect alleged in lawsuits currently filed over the device, according to the Pittsburgh Business Times.
A report on June 30th indicates that Dr. Pamela Moalli, of the Magee-Womens Research Institute, recently received a University of Pittsburgh Center for Medical Innovation award to build a new morcellator, to be used in laparoscopic hysterectomy and fibroid removal surgeries. Morcellators currently on the market are used to remove fibroids through a tiny incision in the abdomen.
The University of Pittsburgh’s new platform for creating a new power morcellator follows a U.S. Food and Drug Administration (FDA) alert in April 2014 that warned of dangers associated with uterine morcellation. Among other things, regulators noted that 1 in every 350 women with fibroids have undetected uterine cancers prior to surgery, and are typically found after a biopsy is administered. Thus, a woman’s long-term chances of survival may be severely diminished. Doctors were discouraged at this time against using power morcellators until regulators could further review possible safety issues. Following the FDA alert, sales of several power morcellators were suspended by the Johnson & Johnson subsidiary, Ethicon Inc., pending further review from regulators. These devices have since been named in power morcellator lawsuits filed in the U.S.
The FDA announced in its April alert that its Obstetrics and Gynecology Devices Panel would convene on July 10th and 11th to discuss recommendations on how to mitigate risks associated with morcellators, to make recommendations on whether to augment their warning labels.
Among other items included on the meeting’s agenda, the Wall Street Journal reported on June 16th that the Panel may discuss whether containment bags should be employed by doctors using morcellators as a means of reducing the spread of uterine cancer. The FDA will then choose whether or not to act on the Panel’s suggestions, according to the Journal.