'Too little, too late' for gel victims

PUBLISHED : Saturday, 15 April, 2006, 12:00am
UPDATED : Saturday, 15 April, 2006, 12:00am
 

Pharmaceutical watchdog belatedly swings into action against manufacturer of toxic substance used in surgery


China's pharmaceutical watchdog will hold a public hearing next week to determine what action should be taken against the mainland manufacturer of a toxic gel used in cosmetic surgery.


But a Beijing lawyer says the action is too little too late, and the authorities should apologise to victims for dragging their feet.


The gel, hydrophilic polyacrylamide but known as PAAG, is commonly used on the mainland for breast augmentation, but the Hong Kong Consumer Council has described the product as cancerous.


Amid the reports and mounting pressure from consumers, the State Food and Drug Administration said this week it would convene the public meeting in Beijing on Tuesday before it makes a decision about what administrative action it will take against the Jilin Fuhua Company in Jilin province .


The drug administration is responsible for medical registration and licensing and Jilin Fuhua is the sole manufacturer of PAAG on the mainland.


'I can only tell you that the hearing is a procedural step before action is taken to deal with the manufacturer in the direction desired by the consumers and victims,' an administration source said.


The gel has been used on the mainland since 1997, but doctors have been divided about claims the product is safe and removable. Quoting top surgeons, China Central Television reported last year at least 300,000 people had been injected with the gel on the mainland.


Most of the country's top-level hospital surgeons do not use PAAG in plastic surgery because of reports of its potentially disastrous impact on a patient's health. But the big profits to be made in the industry encouraged some less scrupulous medical facilities and illegal beauty saloons to use it.


Cao Mengjun, a surgeon from the Shenzhen Fuhua Hospital, the mainland's biggest user of the gel and part of same group as Jilin Fuhua, told CCTV the hospital had injected at least 10,000 people with the product, and 3 per cent of consumers had adverse reactions.


Qiao Qun , director of the Plastic and Aesthetic Surgery Centre at the Beijing Union Medical College Hospital, said once the gel was injected and had triggered an adverse reaction, the material was almost impossible to remove. Hundreds of patients had been referred to him with complications from the gel - pain, infection and material lodging incorrectly in muscle or tissue.


A 23-year-old woman from Guangxi identifying herself as Ms Deng had an injection to enlarge her nose at a Shenzhen beauty salon in March, but three minutes after the material was injected, she became blinded in her right eye.


'I felt extreme pain in my head and ears and my nose swelled into a huge ball, and I immediately knew my right eye was blind,' she said.


She lost her job, had no money and had been abandoned by her boyfriend.


'My life is over. Living is more painful than death for me,' she said.


Wang Ying a 20-year-old Shanghai woman, said she was convinced by Shanghai doctors to have injections in her cheeks, which later spread throughout her facial tissue.


Shenzhen resident Zhang Huiqin has been trying to pursue the manufacturer and Shenzhen Fuhua hospital for damage she alleges occurred as a result of being injected with the gel.


Lawyer Pu Zhiqiang has been helping Zhang Huiqin with her case and said the drug administration's action was too little, too late.


'Its public hearing is good, but it's too late. As the authorisation and monitoring body for medical devices, they should have taken action years ago, instead of now when so many victims have been affected,' Mr Pu said.


'All the administrative departments failed to check and monitor PAAG and they should apologise to the victims.'


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