Implant gel banned26th June 2006
China's State Food and Drug Supervision Administration in April banned an injectable gel known as Ao Mei Ding ('Amazing Gel'), marketed primarily as a beauty treatment to enlarge breasts. But the ban has come too late for hundreds of thousands of Chinese women who paid handsomely for the treatment, often with devastating consequences.
Cao Mengjun, the inventor of Amazing Gel, said in 2004 that more than 300,000 people in China had been injected with it, but doctors say even 500,000 may be too low. Many people hesitate to come forward because they are ashamed, since the gel has been used on the face and breasts as well as to enlarge penises and narrow vaginas.
Fu Hua Pharmaceuticals in northeastern Jilin province manufactured the polyacrylamide hydrogel, which was sold to beauty salons when big hospitals declined to use it. Many salons operate illicitly in China.Doctors say that no one knows how many procedures have gone wrong or precisely what damage the gel can do. But Qiao Qun, head of plastic surgery at Beijing Union Hospital, said she operates a dozen times a week on women whose Amazing Gel implants have gone wrong, and many have had breasts removed.
'In no other country in the world is there a problem like this on such a scale. The numbers of people who may have medical problems are simply enormous,' she said.
The product in it earliest form won approval from the government nine years ago. But Chen Huanren, a senior physician at the plastic surgery hospital at the Chinese Academy of Medical Science, said it should never have been used on humans. Chen alleges that officials took bribes before they approved the substance and that they are now under investigation.
On 1 June, China's official People's Daily newspaper reported that a woman from the southern city of Guangzhou had prevailed in a civil lawsuit against a clinic that provided a harmful breast enlargement operation. The plaintiff sued Guangzhou Huamei Cosmetic and Plastic Surgery Clinic over improper use of polyacrylamide gel. The woman, 36, visited the clinic in May 2005 and was injected with 200 ml of the gel but soon developed pain, lumps, and inflammation of breast tissue.
From 2002-2005, 183 reports of adverse reactions to surgery involving such gels were submitted to the State Adverse Drug Reaction Monitoring Centre.
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