FDA Approves New Tissue Containment Bag To Prevent Spread of Cancer in Power Morcellator Procedures
Power Morcellator Lawsuits and Preventing the Spread of Cancer
Power morcellators have been used by thousands of doctors to assist with hysterectomy and fibroid removal procedures. Approximately 1 in 350 women who undergo such procedures, have undiagnosed uterine cancer. For these patients, use of a power morcellator device carries the risk that cancer cells may spread into the abdomen, shortening patient’s life expectancy.
In 2014, the Food and Drug Administration (FDA) issued a warning, regarding the risks associated with power morcellator device use, specifically the possibility of spreading undiagnosed uterine cancer into patient’s abdomen. Following a morcellator procedure, some women have developed uterine cancers, including leiomyosarcoma, a rare and aggressive form of cancer. This type of cancer also has the potential to spread into the abdomen and cause bowel obstructions, infections and intense pain. In April 2014, Johnson and Johnson pulled three of its power morcellator devices off the market: Gynecare Morcellex, the Morcellex Sigma and the Gynecare X-Tract.
New Device Approved by The Food and Drug Administration
The FDA recently approved use of Advanced Surgical Concepts’ PneumoLiner device for morcellator-assisted procedures. The PneumoLiner is intended to prevent the spread of uterine cancer cells, during power morcellator procedures. The PneumoLiner is a tissue container bag that is inserted into the abdomen, along with a plunger, during a power morcellator procedure. Removed tissues are placed into the PneumoLiner bag, to prevent the transfer of any cancer cells/tissue into the abdomen. Although the product shows some promise, the FDA has required Advanced Surgical Concepts to warn doctors/patients that there is no proof that the PneumoLiner device is effective in stopping the spread of cancer in power morcellator procedures.
The FDA is still reviewing the safety of power morcellator use. For now, Doctors have been warned not to use the devices, and most insurance companies now refuse to cover morcellator procedures due to known risks. Many women who have been diagnosed with uterine cancer following a power morcellator procedure, have filed lawsuits against Ethicon. The suits claim that the company failed to adequately warn doctors/patients of known risks, and failed to make the device safe for its intended use.
Nadrich & Cohen, LLP is currently investigating power morcellator claims. If you or a loved one had a fibroid removal or hysterectomy procedure and subsequently developed uterine cancer or leiomyosarcoma, immediately contact the defective medical device lawyers of Nadrich & Cohen, LLP for a free consultation.