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China bans hydrogel for breast implants
(Xinhua)
Updated: 2006-05-02 11:57
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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.