The FDA permitted in early April the marketing of PneumoLiner — the first tissue containment system for use with certain laparoscopic power morcellators. According to the agency, the tissue containment system will isolate uterine tissue not suspected to contain cancer.
The FDA will require the manufacturer to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.
Approximately one in 350 hysterectomy patients have an unsuspected uterine sarcoma, according to the federal agency. Morcellation spreads cancerous cells to the pelvis and abdomen, making the already-deadly cancer even more serious.
A PneumoLiner, which is essentially a tube-like plunger connected to a containment bag, collects uterine sarcoma cells and isolates them before the bag is sealed and inflated. The inflation creates a working space and allows for enhanced visibility.
Laboratory tests revealed the bag was impermeable to similarly-sized substances and showed the inflation significantly improved visibility for the performing surgeon.
Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, cautioned that the device does not reduce the risk of cancer.
“This new device does not change our position on the risks associated with power morcellation,” Maisel said in a statement. “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.”
Power Morcellators Lawsuits
The FDA approved these devices in 1991. Now, roughly 25 years later, they are used in about 12 percent of hysterectomies, because of their minimally-invasive nature. These gadgets essentially break up uterine tissue and make it easier to remove.
But in so doing, tiny cancerous cells, which neither doctor nor patient may know about, are spread throughout the woman’s body. This spreading often causes serious injury, including:
- Pelvic cancer,
- Serious bleeding,
- Sever pain, and
- Bowel obstruction.
In addition to compensatory damages, victims in these cases are often entitled to significant punitive damages, due to the manufacturer’s misconduct in making and selling the devices.
Our Power Morcellators Case Lawyers Can Help
Our defective medical device attorneys can help if you or someone you care about was injured during or after a procedure that involved a power morcellator. Lawsuits have been filed against the device makers by both patients and their families seeking compensation for injuries caused by the defective medical device. You may be entitled to a settlement.
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Start Your Power Morcellator Lawsuit Claim
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