Row may continue after court upholds breast gel ban

By Wu Jiao (China Daily)
Updated: 2006-10-31 06:28

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 pirate products.

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.