These Once-Popular Medical Devices Drew Government Scrutiny in 2015

In late 2013, media coverage of power morcellators, a tool used during laparoscopic hysterectomies, drew attention to a growing controversy around the device.

Patient advocates said that use of power morcellators to cut up uterine tissue during the laparoscopic procedures may spread bits of tissue containing undetected cancer, which may in turn have led to upstaging of these cancers.

A physician couple, Hooman Noorchashm, MD, and Amy Reed, MD, became loud advocates for banning power morcellators after Reed had a hysterectomy with the device and found out soon after that she had advanced stage uterine sarcoma.

In April 2014, FDA issued a safety communication discouraging use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids. Later that year, the agency published an updated safety communication strengthening its warning against use of laparoscopic power morcellation and recommending manufacturers include contraindication labeling and a warning on morcellator product labels.

Johnson & Johnson withdrew its power morcellators from the market in August 2014 amid potential cancer concerns, and some healthcare systems stopped performing hysterectomies with morcellation.

Not all agreed power morcellators should be banned, though. Some surgeons argued that the benefits of morcellation outweighed the potential adverse events of alternative procedures, like open hysterectomy.

The controversy seemed to peak in 2015 when more insurers limited use of the devices and additional healthcare systems jumped on the bandwagon against power morcellators.

In May 2015, the FBI was reportedly investigating the use of power morcellators. In September 2015, the U.S. Government Accountability Office agreed to examine why the public wasn’t told earlier about the potential safety risks of the devices.

Since then, manufacturers of the devices have turned to new innovation to address the concerns.

Olympus launched the moresolution power morcellator, which is manufactured by Geisingen, Germany-based Trokamed and is available in the United States through a distribution agreement with Olympus America. The moresolution morcellator is designed for advanced gynecologic procedures with large, calcified tissue specimens.

Olympus noted that current FDA guidance on power morcellator labeling requires that all power morcellators marketed in the United States be used with a compatible, FDA-cleared containment device. The Olympus Contained Tissue Extraction System comprises the PneumoLiner, a containment device, and the moresolution Morcellator, which together provide select patients a laparoscopic surgical option as an alternative to open hysterectomy or open myomectomy for tissue removal.

"Olympus supports the safe use of power morcellators with a contained extraction system according to FDA guidance," said Richard Reynolds, president of the medical system group at Olympus America. "This device reflects a response to our customers' requests for more power and control during the procedure. This particular device works very well on very dense, calcified tissue, which is difficult to cut with other devices."

Contained tissue extraction is not indicated for use with women who have a known or suspected malignancy, the company noted. FDA advises that power morcellation should not be used for removal of uterine tissue containing suspected fibroids in patients who are post-menopausal or over 50 years of age or who are candidates for en bloc tissue removal vaginally or via a mini-laparotomy incision.