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FDA Approves New Power Morcellator Amid Cancer Concerns

four surgeons operating

The U.S. Food and Drug Administration has approved a new surgical tool for use in certain gynecological procedures, the device’s maker, Olympus America Inc., announced Wednesday.

The PK Morcellator is an electrical device intended for cutting and removing tissue in laparoscopic — or minimally invasive — gynecological procedures, according to the FDA.

Power morcellators have been a source of controversy since 2014 when the FDA announced their use during surgery could spread lethal cancer in the body.

To use morcellators, doctors insert the long, tube-like portion of the drill-shaped device into small incisions in the body. Then, they cut up benign growths called fibroids and remove the pieces through the incisions.

However, one in 350 women has the chance of harboring cancerous tumors that can’t be reliably detected before surgery, the FDA has said. This unsuspected cancer could spread during the procedure, decreasing the long-term survival of patients.

As a result, the FDA ordered its strongest warning, a “black-box” warning, on the devices and said they shouldn’t be used in the majority of women who undergo hysterectomy and myomectomy.

Johnson & Johnson pulled its power morcellator from the market, and in March, the company had settled nearly 70 of the roughly 100 claims related to the now-discontinued device. Some of the settlements ranged from $100,000 to about $1 million, according to a Wall Street Journal report.

New Morcellator ‘Substantially Equivalent’

The FDA approved Olympus’ new PK Morcellator under its 510(K) protocol, which does not require human testing. Instead, the manufacturer had to prove the device was “substantially equivalent” to similar devices already on the market.

With a pistol grip and an improved smoke evacuation system, the PK Morcellator is designed to give doctors improved visibility during procedures and an option of how to hold the tool. The device has a lip on the distal tip that allows a “peeling” removal of tissue as compared to a “coring” technique.

The FDA has recommended doctors use the device along with the manufacturer’s PneumoLiner containment device for removal of uterine tissue.

The liner creates a barrier between the targeted tissue and other areas to reduce the risk of unintentional damage. The FDA approved the liner in April.

Morcellator Called ‘Solution’

“The Olympus Contained Tissue Extraction System provides gynecologists and their appropriate, low-risk patients with what they want again: a choice,” president of Olympus Medical Systems Group, Todd Usen, said in a news release. “The Olympus Contained Tissue Extraction System is the solution that will allow gynecologists to once again safely and effectively offer minimally invasive hysterectomies and myomectomies as options to certain low-risk patients.”

Doctors carry out nearly 600,000 hysterectomies in the U.S. annually — more than half involve minimally-invasive surgery. Prior to its 2014 warning, the FDA estimated that doctors performed about 60,000 morcellations each year.

Kevin Connolly
Written By Kevin Connolly Editor

Kevin Connolly joined Drugwatch in 2016 after 20 years as a newspaper reporter and editor. He is a member of the International Society for Medical Publication Professionals, the Drug Information Association and Investigative Reporters and Editors. Some of his qualifications include:

  • Centers for Disease Control and Prevention certificates in Health Literacy
  • Bachelor of Arts in Mass Communications from University of South Florida
  • Classes completed at Seminole State College of Florida in biology, microbiology, chemistry, anatomy and physiology

4 Cited Research Articles writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. U.S. Food and Drug Administration. (2016, October 7). Retrieved from
  2. U.S. Food and Drug Administration. (2014, November 24). FDA warns against using laparoscopic power morcellators to treat uterine fibroids. Retrieved from
  3. Olympus America Inc. (2016, November 16). Olympus Introduces First-of-its-Kind Contained Tissue Extraction System, Restoring Healthcare Option for Gynecologists and Women. Retrieved from
  4. Levitz, J. (2016, March 18). Johnson & Johnson Settling Cases Tied to Device That Can Spread Uterine Cancer. Retrieved from
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