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Brenntag denies negligence in escalating breast implant row

Brenntag has denied accusations of negligence in supplying silicone to PIP

GERMANY-FRANCE

Brenntag, the world's largest chemicals distributor, has denied accusations of negligence in its role as a silicone supplier to Poly Implant Prothese (PIP), a French company which is at the centre of an international storm about dangerous breast implants. The firm has said that the silicone it supplied to PIP was never intended for use in such applications and was clearly marked as such.

In 2010, the French government ordered PIP implants off the market and advised 30,000 women who have had the implants to have them removed because of high rupture rates. Governments in other countries, including the UK and Brazil, have asked women to consult doctors. PIP, which has now ceased trading, may also face involuntary homicide charges in France as part of an investigation into a woman with the implant dying of cancer.

According to the German daily newspaper Handelsblatt, a Munich-based law firm called Zierhut & Graf is preparing to press civil charges on behalf of a client against Brenntag, as well as the surgeons and the clinic that had treated her. Zierhut & Graf has declined to comment officially.

The PIP implants scandal has been front-page news in several European countries

PIP reportedly used a silicone that was not approved by health authorities in the implants it had sold since 1991. Brenntag sold PIP Baysilone industrial grade silicone oils, which normally go into sealing materials for construction and electronic components, but said that they were clearly labelled as not fit for use in implants and that it had no reason to believe they could be misused.

"PIP presented itself as a diversified healthcare provider that offers and distributes different med-tech products globally," Brenntag stated. PIP's product range includes wound dressing pads and scab and prosthesis cushions, as well as implants, so there was no evidence that any products delivered to it by Brenntag were intended for use in the human body. Moreover, like any medical device manufacturer, it would have been under the supervision of the French health authority, AFSSAPS.

Brenntag added that is not aware of the composition of the implant filling dubbed the 'PIP mix' in the media or of whether or to what extent its silicone oils have been used in the implants. If they have been, it said, "they could only have made their way into the implant through intentional criminal and improper use [by PIP], as the oils had been clearly classified as intended for industrial use only".

Silicone oils can be sold without restrictions and suppliers are not legally required to monitor subsequent use. They rarely do so in any case, Brenntag added, "because the confidentiality of proprietary formulations and production processes is common practice across many sectors".

 

 

From Online Issue: February 2012