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On April 7, the FDA announced it would permit the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. While the device has shown to be effective in the area of tissue containment, the federal agency requires the manufacturer to warn patients and health-care professionals of the potential dangers of using power morcellators on tissue containing undetected cancer and that the PneumoLiner device has not been proven to reduce the risk of spreading cancer during laparoscopic procedures.
The FDA has estimated that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids are found to have an unsuspected uterine sarcoma. If morcellation is performed on these women, there is a risk that the procedure will spread the cancerous tissue throughout the body, particularly within the abdomen and pelvis, and could lessen a patient’s likelihood of long-term survival of the disease.
At this time, the PneumoLiner device has not been proven to reduce the spread of potentially cancerous tissue during power morcellation.
Risks associated with the PneumoLiner device include dissemination of morcellated tissue, injury to surrounding tissues or organs, infections and a prolongation of the surgical procedure. The required labeling for the device must state that use of the device is limited to physicians who have successfully completed the company’s validated training program.
The device must also carry a boxed warning that alerts women and health care providers to the potential risks associated with power morcellation of uterine tissue. Risks associated with power morcellation of uterine tissue include the spread of some forms of cancer.
Many women who have had surgery to remove uterine fibroids or had a hysterectomy performed where the doctor used a power morcellator have had unintended consequences as a result. Some have experienced the spread of undetected cancer throughout their bodies because of these surgical devices.
If you or a loved one has suffered due to the use of a power morcellator, you have rights. If you yourself are facing a serious health crisis or if you have lost a loved one contact the Strong Arm Attorney in Atlanta, John Foy & Associates.
We want to help and you may be entitled to compensation to cover medical bills, cancer treatments, lost work as well as pain and suffering and wrongful death. Contact us today to schedule a free consultation regarding your power morcellator case. Call us today at (404) 800-4635 to schedule your free consultation.
