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Amid continuing concerns about the cancer risks with laparoscopic hysterectomy procedures, federal regulators have approved use of the first tissue containment system to be used with power morcellators, which may help reduce the spread of undiagnosed uterine sarcoma that may be contained within the uterus.
In a statement issued April 7, the FDA announced it is permitting the marketing of the PneumoLiner, which can contain uterine tissue released by certain laparoscopic power morcellators.
Morcellation is a critical part of minimally invasive hysterectomy and uterine fibroid removals, allowing doctors to remove the uterus or fibroids through a small incision in the abdomen.
Although laparoscopic procedures reduce the risk of infections and shorten recovery time, concerns about risk of power morcellators spreading hidden cancers have caused the devices to be largely abandoned by the medical community, since there is no way to detect which women may have hidden or unsuspected sarcoma contained within the uterus.
The FDA has previously suggested that about 1 in 350 women who undergo hysterectomy or myomectomy for uterine fibroid removal may have unsuspected uterine sarcoma, and the morcellator may cause this cancerous tissue to be spread throughout the body, rapidly upstaging leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers to a very advanced stage that is difficult to treat and life-threatening.
“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,” Dr William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the press release. “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.”
It is hoped that if women have undiagnosed uterine sarcoma or leiomyosarcoma, the containment system could catch the cancerous tissue and prevent it from spreading.
Healthcare professionals have attempted to use containment systems in the past to catch morcellated tissue, but there has been no evidence that their use prevented the spread of cancer. This is the first system specifically approved for the containment or morcellated tissue.
The PneumoLiner consists of a containment bag and a tube-like plunger used to place the device into the abdominal cavity. Tissue to be removed is placed in the bag, which is sealed and inflated so that the tissue is trapped inside during morcellation procedures. The FDA says the device was tested in worst-case and best-case scenarios and was found to be impermeable to substances on a molecular level similar in size to morcellated tissues, cells and bodily fluids.
The FDA also indicates that testing has shown the device allowed doctors good visualization and adequate space to perform their procedures.
The known health risks of the device include potential dissemination of morcellated tissue, a risk of injury to surrounding tissues and organs, infections, and a prolonged medical procedures. The device will carry labeling indicating that it is only meant to be used by physicians who have succesfully completed a validated training program offered by the manufacturer.
Morcellator Cancer Lawsuits
The approval of the device comes amid a growing number of morcellator cancer lawsuits being pursued against Ethicon, Karl Storz and other manufacturers of these devices, alleging that women and the medical community were not adequately warned about the potential risks associated with electing a laparoscopic hysterectomy.
The litigation emerged after the FDA raised concerns about the link between uterine morcellation and cancer in early 2014.
After concluding that there is no way to make the devices safe for women, Johnson & Johson’s Ethicon unit issued a morcellator recall in July 2014, and announced that they would no longer manufacturer or sell the devices. The company controlled about three quarters of the power morcellator market. A number of other manufacturers still sell the devices despite the FDA warnings.
Since October 2015, all Ethicon morcellator lawsuits filed throughout the federal court system have been consolidated as part of a federal MDL, or multidistrict litigation, which is centralized before U.S. District Judge Kathryn H. Vratil in the District of Kansas. Settlements have already been reached in a large number of cases.