Irish startup Advanced Surgical Concepts recently received approval from the U.S. Food and Drug Administration (FDA) to sell its tissue containment system for use with laparoscopic power morcellators. The FDA’s approval is under the agency’s de novo process, which is reserved for low to moderate-risk devices considered to be novel.
The containment system, known as the PneumoLiner, is made up of a containment bag and a tub-like plunger that positions it within the abdominal cavity. The tissue being removed gets placed in the bag, which is sealed and inflated before surgeons begin to morcellate the tissue within it.
Power morcellators have been the subject of controversy since the FDA issued a safety communication in 2014 discouraging their use for the removal of the uterus (hysterectomy) and uterine fibroids (myomectomy). The controversy has only continued to grow as more and more women have made the decision to file a power morcellator lawsuit, claiming that the use of laparoscopic power morcellators spread undetected cancer tissue in their bodies.
According to research cited by the FDA, one in 350 women who undergo a hysterectomy or myomectomy for the removal of fibroids has undetected cancer cells. A good number of hysterectomies and myomectomies are performed every year using power morcellators, which shred tissue targeted for extraction, eliminating the need for invasive surgery. However, research has shown that when a power morcellator is used in either of these procedures on women with undetected cancer cells, the cancer can easily be seeded throughout the pelvic and abdominal cavity.
This finding prompted the FDA to require manufacturers to put a black box warning—the agency’s strictest warning—on the packaging of power morcellator devices and prompted many women to consider filing their own power morcellator lawsuit
PneumoLiner Not Proven to Eliminate Spread of Cancer During Morcellation
The idea behind the PneumoLiner is to contain noncancerous tissue from spreading to the pelvic and abdominal areas during power morcellation. The new device effectively contains morcellated tissue, according to the FDA, which has cleared the device for use specifically on women without uterine fibroids undergoing a hysterectomy or some premenopausal women with fibroids who wish to maintain their fertility and keep their uterus.
But what about the one woman out of the 350 who has undiagnosed cancer and undergoes this procedure with a power morcellator?
According to a new report published in the Journal of the American Medical Association, the PneumoLiner has not been proven to reduce the risk of cancerous tissue being spread to other parts of the body. This is why FDA officials are requiring Advanced Surgical Concepts to label its new device, cautioning clinicians that it is only to be used in a limited patient population. The PneumoLiner is not to be used during gynecological surgery on women suspected of having cancer.
The black box warning for the PneumoLiner is similar to the recommended warning for power morcellator devices:
“Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.”
According to William Maisel of the FDA’s Center for Devices and Radiological Health, the agency’s position on power morcellators hasn’t changed. “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,” he said in a statement.
Johnson & Johnson Power Morcellator Lawsuit Settlements
The reported danger associated with power morcellators has prompted many to file a power morcellator lawsuit against manufacturers. One such power morcellator manufacturer, Johnson & Johnson, has been named in roughly 100 power morcellator lawsuits.
In March, Johnson & Johnson announced that it had reached roughly 70 power morcellator lawsuit settlement agreements within the past few months. A person familiar with some of the company’s power morcellator lawsuit settlements indicated that the amounts received by plaintiffs thus far have ranged between $100,000 and $1 million. It is safe to assume that J&J will spend many more millions to settle each remaining power morcellator lawsuit.
Power Morcellator Lawyer
Hundreds of women across the U.S. have made the decision to file a power morcellator lawsuit after developing cancer following a hysterectomy or myomectomy in which a power morcellator was used. These victims claim that power morcellator manufacturers failed to warn the public about the risks and dangers associated with using the devices. By filing a power morcellator lawsuit, victims are seeking compensation to cover their staggering medical bills, as well as their pain and suffering.
Power morcellator manufacturers have a duty to inform patients of any risks associated with the use of their devices. Unfortunately, many power morcellator companies failed in this duty and now they should be held accountable for the damage they have caused.