BEIJING, Sept. 28 (Xinhua) -- Even though its product was proven to cause severe side affects, a breast enlargement product manufacturer is suing the State Food and Drug Administration (SFDA) for banning its product.

The SFDA banned Ao Mei Ding or "Amazing" in April after a report by the SFDA on the gel chemical showed that 7.75 percent of the women who were injected with the liquid had adverse reactions. Some women had to have a mastectomies to alleviate their symptoms.

The report showed 11,360 women had been injected with the gel for breast enlargement purpose from 2002 to 2006 and 880 suffered adverse side affects.

"The gel chemical, which disqualified 'Amazing' in the drug agency's evaluation, is quite likely to leave residues within human body, causing great harm to human body," a SFDA representative said on court, adding that the breast-enlarging gel "Amazing" must be banned for containing the chemical.

"Amazing" is banned as it cannot tackle the residue problem, said the SDFA, adding that the evaluation is not solely targeted at "Amazing" or any other particular product but at the gel chemical.

Up to April this year, the SFDA had received 189 reports of adverse reaction to the gel. The product manufacturer, Jilin Fuhua Medical Polymers Company Ltd., defended itself by saying most of the gel products in the SFDA evaluation are counterfeit instead of legitimate "Amazing" products.

"The evaluation report did not explain among 189 reports how many side-effect cases are caused by our product," said the company, "it's unjust to put blame only on "Amazing" as many other gel breast enlargement products are manufactured by unregistered medical companies."

Compared with those "black workshops", Jilin Fuhua is the sole legitimate medical gel manufacturing enterprise in China, and it's state- approved and safe, said the company that started to produce "Amazing" in 1999.

For the past decade, Chinese medical experts have been divided on gel as breast-enlargement component, some saying it's bad for the health of women to enlarge breast by injecting gel, others believing breast enlargement by gel is convenient, safe and painless.

On court, the two parties also debated on the legitimacy of the procedures of the SFDA imposing the "Amazing" ban. The case, which is being heard at Beijing No. 1 Intermediate Court, has not yet concluded.

About 173,480 cases of adverse drug reactions were reported in China last year, according to the SFDA. Enditem