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BEIJING, May 1 (Xinhua) -- The Chinese government has
banned the production, sale and use of polyacrylamide hydrogel, an implant
widely used in breast operations.
The State Food and Drug Administration (SFDA) has announced the
material can no longer be registered and certified after reports of patients
suffering complications with implants.
Polyacrylamide hydrogel has been widely used in
parenchyma implants, including orthopedic operations for breasts, cheeks and
hips.
Many Chinese women are following a growing trend to
reshape their breasts with expensive cosmetic surgery. A random search on
google.com reveals more than two million Chinese web pages on the topic, mostly
from clinics promising women the perfect body.
The state monitoring center for side-effects of
medicines received 183 reports of adverse effects from the use of hydrogel from
2002 to November last year -- 182 involving women and just one a man.
A total of 161 cases were reported from breast
implants operations, with phenomenon including infection, deformation and
hardening.
An official with the SFDA said the ban was
implemented because the safety of the hydrogel could not be guaranteed.
The SFDA demanded all enterprises stop production
immediately, recall all complete products, and "destroy all recalled products
and those in stock" under the supervision of local food and drug
administrations.
Failure to do so would result in prosecution, the
official said.
The SFDA declined to revealed the number of
enterprises involved or the exact amount of the material produced. Enditem
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