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 that
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 reveal the number of enterprises involved
or the exact amount of the material produced.
(Xinhua News Agency May 2, 2006)