China bans hydrogel for breast implants

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China bans hydrogel for breast implants

www.chinaview.cn 2006-05-01 17:44:09

http://news.xinhuanet.com/english/2006-05/01/content_4498825.htm

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.

Editor: Chen Feng