April 11, 2016 — Two decades after laparoscopic power morcellators hit the market, the FDA has approved the first surgical bag to contain tissues.
The PneumoLiner is a containment bag and a tube-like plunger. The bag is designed to enclose an organ and inflate, which creates a working space that allows for visualization during surgery and helps prevent breaking the bag with the tip of the morcellator or other instruments.
The FDA warns that power morcellators should not be used in the “vast majority” of women. The PneumoLiner is only intended for women who do not have fibroids or pre-menopausal women with fibroids who want to maintain their fertility.
Potential risks include dissemination of malignant tissue, infection, damage to nearby organs, and prolongation of the surgery. The agency also placed a similar “Black Box” warning on the PneumoLiner as 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.”
Morcellators are surgical tools that are used during fibroid surgery and hysterectomies to grind up uterine tissue into pieces that can be removed through small incisions. When a morcellator grinds up cancerous tissue, tumors can spread throughout a woman’s pelvis and abdomen and greatly worsen her changes of long-term survival.
In the past, hand-operated morcellators were almost always used with surgical bags. When power morcellators hit the market in the 1990s, the bags were rarely used because they were cumbersome and most surgeons though the risk of spreading cancer was low. That all changed two years ago, when the FDA warned that 1 in 350 women undergoing a hysterectomy or fibroid surgery actually has undiagnosed uterine sarcoma, and 1 in 500 has highly-aggressive leiomyosarcoma.
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