The row over a breast enlarging gel Monday night threatened to rumble
on, despite a ruling in favour of the State Food and Drug Administration (SFDA).
The Beijing First Intermediate People's Court yesterday supported SFDA's
decision to ban "Aomeiding," a "man-made fat" designed to be injected into the
breasts, after many users reported serious side effects.
But the ruling left representatives of the Jilin Fuhua Medical Macromolecule
Material Company, the country's only officially approved breast enlargement
products firm, vowing to take the case to Beijing People's High Court.
Zhao Jiangming, lawyer for Jilin Fuhua, said the verdict missed the key point
whether the products that caused serious problems and led to the ban were truly
their products, or illegal pirated ones.
SFDA banned the company from producing and selling the gel in April, after
floods of complaints from users.
A report shown by the administration's Drug Re-evaluation Centre says about
7.5 per cent of the 11,360 users investigated reported negative reactions
ranging from pain caused by the gel moving to other parts of the body, through
to having to have their breasts removed.
The report, based on four-year investigation, concluded that all forms of
injected gel were technically unsafe.
But the company claimed it had been made a scapegoat for injuries caused by
It sued SFDA in August, demanding the ban be reversed.
The company said the fact the gel had already been proved safe by SFDA in
medical trials showed it was not responsible for the injuries.
SFDA approved the use of "Aomeiding" on a trial basis in 1999, giving
production the green light in 2000.
The product was re-registered in 2005, in accordance with the related
regulations, meaning no negative cases could have occurred before then, said
Jilin Fuhua representative Cai Wenzhi.
But SFDA refuted the company's claims, saying that a production licence did
not mean SFDA would not supervise its market safety and revoke its licence after
sufficient proof the product was dangerous.
Before the April ban was enforced, "Aomeiding" had been used by more than
300,000 women, becoming popular in beauty salons and hospitals nationwide.
The ban has hit customers' trust as well as slicing 30 per cent off beauty
industry profits, Zhang Xiaomei, a beauty magazine editor, was quoted by the
Beijing Morning Post as saying.