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FDA Approves Morcellator Bag to Prevent Cancerous Tissue Spread

Doctors ready for surgery

The U.S. Food and Drug Administration allowed an Irish company to market its new power morcellator tissue collection system. The bag is one-of-a-kind and promises to trap potentially cancerous tissue and prevent it from spreading in the body during laparoscopic hysterectomies and fibroid removals.

Advanced Surgical Concepts Ltd developed the tissue containment system for use called the PneumoLiner last year. Before performing minimally invasive surgery with a power morcellator, surgeons insert the tissue bag into the abdomen with a tube-like plunger. Surgeons place the tissue they intend to morcellate in the bag. The bag is then inflated and sealed, trapping all bits of tissue and fluids for removal.

While the FDA approved the bag for sale, it stands by its 2014 warning that power morcellators used to cut up tissue into small chunks during minimally invasive surgery are still risky for the majority of women. As many as 1 in 350 women may have undiagnosed uterine cancer that can be cut up and spread in the body by morcellators.

Johnson & Johnson pulled their three morcellators off the market after the warning, but about 30 women filed lawsuits against the company’s Ethicon unit claiming their cancer was worsened by the devices.

“The PneumoLiner is intended to contain morcellated tissue in the very limited patient population for whom power morcellation may be an appropriate therapeutic option – and only if patients have been appropriately informed of the risks,” William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a statement. “This new device does not change our position on the risks associated with power morcellation. We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids.”

The new bag is not guaranteed to stop the spread of cancer. In fact, the packaging of the product must also list several warnings, including one that reads, “The use of this containment system has not been clinically demonstrated to reduce this risk.”

FDA also requires physicians to complete a company training program before using the containment system.

Bag Leakage Still Possible

There is no proof the PneumoLiner is effective, and one new study shows tissue and fluid could still leak from the bag.

The February 2016 study published in the American Journal of Obstetrics and Gynecology by Cohen et al. revealed nearly 1 in 10 containment bags could leak fluids and tissue. In the study, seven out of 76 patients had fluid spread, but the study did not name the containment system used.

“These instances do represent potential opportunities for tissue dissemination,” the authors wrote. However, they add that in traditional surgical techniques there is also a chance for fluid spread and recommended further refinement of the containment technique.

Frank Bonadio, Advanced Surgical’s CEO, said the PneumoLiner is safe and provides complete containment.

Morcellator Controversy Continues

Controversy surrounding power morcellators began after the FDA issued its 2014 warning, and a number of doctors are still divided.

Some argue the devices cut down on complications and recovery time from traditional surgeries. Others like Dr. Hooman Noorchashm — whose wife, Dr. Amy Reed was diagnosed with leiomyosarcoma after a morcellator hysterectomy — want morcellators removed from the market.

“FDA ought to have classified this as a [high-risk] Class III device and taken it through the Premarket Approval process,” said Noorchashm in an email to Peter Lurie, the FDA associate commissioner for public health strategy and analysis.

Shortly after the FDA warning, Johnson & Johnson’s Ethicon unit withdrew its devices from the market. Several insurance companies stopped paying for the procedure and a number of hospitals stopped using the devices.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • Member of American Medical Writers Association (AMWA) and former Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine

3 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. Bing Han Ong, M. (2016, April 8). FDA Allows Containment Bags for Power Morcellators; Paper Reports Leakage. The Cancer Letter. Retrieved from
  2. FDA. (2016, April 7). FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients. Retrieved from
  3. Cohen, S. et al. (2016). Contained tissue extraction using power morcellation: prospective evaluation of leakage parameters. Retrieved from
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