The Beijing First Intermediate People's Court yesterday
supported the State Food and Drug Administration’s (SFDA) decision
to ban "Aomeiding", a "man-made fat" designed to be injected into a
woman’s breasts as an enlargement procedure, 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 the 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 actually theirs or illegal pirated ones.
The SFDA banned the company from producing and selling the gel
in April, after receiving a flood of complaints from users.
A report produced in court by the administration's Drug
Re-evaluation Center says about 7.5 percent of the 11,360 users
investigated reported negative reactions ranging from pain caused
by the gel moving to other parts of the body, to having to have
their breasts removed in extremely serious situations.
The report, based on a four-year investigation, concluded that
all forms of injection gel were technically unsafe.
But the company claimed it had been made a scapegoat for
injuries caused by pirate products.
It sued the SFDA in August, demanding the ban be reversed.
The company said the fact the gel had already been proven safe
by the SFDA in medical trials showed it was not responsible for the
injuries.
The 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 the SFDA refuted the company's claims, saying that a
production license did not mean it would not supervise the
product’s market safety and revoke the license if it had sufficient
proof that the product was dangerous.
Before the April ban was enforced, "Aomeiding" had been used by
more than 300,000 women, and had become popular in beauty salons
and hospitals nationwide.
The ban has affected customer confidence as well as sliced off
30 percent from beauty industry profits, according to Zhang
Xiaomei, a beauty magazine editor, as quoted by the Beijing
Morning Post.
(China Daily October 31, 2006)