Copyright © 2002 - Hydrogel breast implant is withdrawn from sale ~Independent 'Unsafe'
Date: Tue, 12 Dec 2000 15:16:06 -0800
From: ilena rose
ilena@san.rr.comThank you Margo for this important information that can be widely distributed. and thanks to all who have worked so hard to warn the women in Europe and Britain.
I would think a better report would have included this warning: "...pathological changes suggesting a systemic effect in rabbits following implantation of the filling material for 28 days." The MDA site also discusses that there has already been one rupture reported. What happens when this substance is mixed with body fluids, since they "swell in water"?
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By Jeremy Laurance
12 December 2000
A second type of breast implant was withdrawn from sale yesterday after government investigators concluded it could not be regarded as safe.
The implants, given to about 4,250 women in Britain, are filled with hydrogel, a plastic material that swells in water. The makers of the implants withdrew them from the market after the Medical Devices Agency (MDA), which has been examining breast implants, said safety assessments done on the hydrogel fillings had been inadequate.
Last year soya-oil breast implants were withdrawn from sale amid safety fears. Women who had them - about 5,000 in Britain - were later advised to have them removed.
Both types of implant were introduced in the mid-1990s in response to fears over the safety of silicone implants, which remain on the market.
The latest withdrawal is certain to heighten anxiety about the safety of all implants, despite government reassurance yesterday that there was no need for women with the hydrogel type to have them removed. Unlike the soya-oil implants, which leaked and caused reactions in scores of women, there have been no reports of problems or complaints about the hydrogel kind.
Dr Pat Troop, the Government's deputy chief medical officer, said: "It must be stressed that no definite health risk has been identified. At present there is no information to indicate that there is any risk to women with these implants, or their children. The recall is purely a precautionary measure, until the manufacturers have addressed MDA's concerns regarding their biological safety assessments."
The Department of Health said the MDA's review had revealed inadequacies in the makers' biological safety assessments on two brands of the implants and concluded that there was not enough information to assess either of their filler materials fully.
"No definite risk has been identified. There are no known cases of harm caused by these breast implants and there is no evidence to suggest they should be removed from women who currently have them. The concern is only with the way the safety of the hydrogel fillers has been assessed," the department said.
The first product affected by the warning is the PIP hydrogel breast implant, made in France and supplied in Britain by Clover Leaf Products. About 4,000 women in the UK have received these since they were introduced in 1994.
The second is the NovaGold implant, made in Germany and supplied in Britain by Somatech Medical. About 250 women have received these since they were introduced in 1996.
Hydrogels are used in other products, such as contact lenses, medicines, surgical dressings and food, but the department said these were not affected by the warning.
Women who have the implants and are concerned are advised to contact their surgeon or GP. About 80 per cent of hydrogel implants in use were inserted for cosmetic reasons by private clinics, the Department of Health said.
