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While the medical community has moved away from the use of power morcellators in recent years, due to the risk that cancer may be spread during minimally invasive hysterectomy procedures, Olympus has gained FDA approval for a new device that comes equipped with a tissue containment back, meant to contain unsuspected cancerous cells.
Power morcellators are medical devices used during laparoscopic hysterectomies and myomectomies, allowing surgeons to cut up the uterus and uterine fibroids through a small incision in the abdomen. The procedures were often recommended instead of open procedures over the past decade, since they generally limit the risk of complications and reduce recovery time.
Since 2014, the devices have been largely abandoned by hospitals and surgeons, after it was discovered that morcellation may spread lyomyosarcoma, endometrial stromal sarcoma or other undiagnosed cancers that may be hidden within the uterus, causing the previously contained cancer to rapidly spread throughout the body.
This week, Olympus issued a press release to announce a new device intended to address these concerns, with a tissue containment bag attached to the power morcellator. However, the manufacturer warns that the device is still not recommended for use on women that are suspected of having uterine fibroids that may contain cancer cells.
The Olympus Contained Tissue Extraction System includes a built-in containment bag designed to collect tissue shredded by the morcellator blades and to keep the debris from spreading throughout a woman’s body cavity. The concept has been around for years, but no one has been able to prove that the bags work in preventing the spread of cancerous cells, and doctors complained about the difficulties in using separate bags in the past.
In the press release, Olympus calls the morcellator a “first of its kind” design, however, the device was approved through the FDA’s 510(k) fast-track approval process, which stipulates that the design must be “substantially equivalent” to an existing medical device to avoid a detailed premarket approval process to properly determine its safety and effectiveness.
It is unclear how a “first of its kind” design could also qualify as “substantially equivalent” to an existing medical device from the press release.
Since warnings about the link between cancer and morcellation were issued by federal regulators in April 2014, the medical community has largely abandoned the use of morcellators, and Johnson & Johnson’s Ethicon unit, which was previously the main manufacturer of the device, stopped selling the tool.
Johnson & Johnson has faced dozens of morcellation lawsuits brought on behalf of women who suffered upstaged uterine cancer after a laparoscopic procedure, and wrongful death claims by family members who had died of such cancers.
While most of those cases have been resolved through morcellator settlement agreements, a number of other morcellator manufacturers continue to face claims alleging that they failed to warn the medical community about cancer risks.