FDA approves tissue
container for laparoscopic device
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[April 08, 2016]
(Reuters) - The U.S. Food and Drug Administration approved a
tissue container bag for use in certain laparoscopic procedures along
with power morcellators, that have been linked to the spread of cancer
Power morcellators are devices used in gynecological procedures like
hysterectomy where the uterus or the uterine fibroids are cut into
smaller pieces and extracted through small incisions.
The tissue container bag, PneumoLiner, developed by privately held
Advanced Surgical Concepts Ltd, is then inserted into the abdomen
and the tissues removed during the procedure are placed into it.
The FDA estimates that about 1 in 350 women who undergo surgical
procedures for fibroids is found to have an unsuspected uterine
If morcellation is performed on these women, there is a risk that it
will spread the cancerous tissue within the abdomen and worsen the
patient's likelihood of long-term survival, the FDA said in a
The health regulator, in 2014, had warned against using these
morcellators for surgical purposes as they flagged serious risks
such as the spread of cancer.
Johnson & Johnson immediately suspended the worldwide sales of its
morcellator after the FDA imposed the warning. (http://reut.rs/1SDgiXP)
The FDA said on Thursday that the PneumoLiner's label should contain
a boxed warning stating that the use of these container bags does
not reduce the risk of cancer that might spread through using the
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Boxed warning is issued by the FDA to flag serious risks associated
with using a drug or a device.
Uterine fibroids are non-cancerous growths that originate from the
smooth muscle tissue in the wall of the uterus. Laparoscopic power
morcellation is one of several available treatments for fibroids.
(Reporting by Rosmi Shaji in Bengaluru; Editing by Shounak Dasgupta)
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