April 11, 2016 — The FDA has approved the first surgical bag to contain tissue fragments produced by a power morcellator.
The PneumoLiner consists of a containment bag and a tube-like plunger to deploy it in the abdomen and inflate it around the uterus. According to the FDA, potential risks include:
- Dissemination of morcellated tissue
- Injury to surrounding tissues or organs
- Prolongation of the surgical procedure.
The PneumoLiner is only intended to be used in women without uterine fibroids who are undergoing a hysterectomy and some pre-menopausal women with fibroids who do not want their uterus removed. It will have the following “Black Box” warning label, which is similar to the one on power morcellators:
“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.”
In the past, the FDA has warned that power morcellators should not be used in the “vast majority” of women because they can disseminate cancerous tissue. The agency estimates that 1 in 350 women who have a hysterectomy also have undiagnosed uterine sarcoma, and 1 in 500 have highly-aggressive leiomyosarcoma. If a morcellator is used, it can spread cancerous tissue and significantly worsen the patient’s chance of long-term survival.
Despite hundreds of adverse events, the FDA decided not to ban the devices. The agency has come under criticism for failing to address the risk of cancer for over 20 years. Before power morcellators hit the market in the 1990s, hand-operated morcellators were almost always used with surgical containment bags. Surgeons typically enclosed an organ in the bag before cutting it by hand.
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