13 January 2012 15:52 [Source: ICIS news]
LONDON (ICIS)--Chemicals supplier Brenntag rejects as unfounded a claim from a German law firm that it may have violated its product-monitoring duties while supplying industrial-grade silicone oils to French company Poly Implant Prothese (PIP), which allegedly illegally used the supplies to make breast implants, Brenntag said on Friday.
Munich-based law firm Zierhut & Graf said it may bring a damages claim on behalf of a female client who wants the chemicals supplier to pay treatment costs and compensation for pain and suffering.
Under scrutiny were Brenntag’s product-monitoring duties under the local government laws applicable to the city where it is based, Muelheim an der Ruhr, in western Germany’s North Rhine-Westphalia state, the law firm added.
French investigators believe PIP might have sold up to 300,000 implants made with non-medical grade silicone filler in 65 countries during the 12 years prior to March 2010, when French health inspectors pulled the prostheses from the market, citing concerns that they may have a high rupture rate. Medical opinion around the world remains divided as to whether all women with the implants should seek to have them removed.
In a statement on the possible damages claim, the chemicals supplier said: “Brenntag considers the allegation of a potential breach of the monitoring obligation in the PIP incident as unfounded.
“Brenntag is not aware of the composition of the implant filling called the ‘PIP mix’ [referred to] in the media. It is still unclear to this day to what extent the products delivered by Brenntag have been at all used in the implants.
“If the silicone oils delivered under the product name of Baysilone are part of the PIP breast implants, they could only have made their way into the implants through intentional criminal and improper use by the French manufacturer PIP, as the oils had been clearly classified as intended for industrial use only.”
Silicone oils can be sold without restrictions, and for suppliers, there is no legal requirement to monitor subsequent use, Brenntag said.
“Monitoring by suppliers is also unusual because the confidentiality of proprietary formulations and production processes is common practice across many sectors,” it added.
Brenntag said that PIP introduced itself to the chemicals supplier “as a broadly positioned healthcare provider that also manufactures and sells various medical devices globally in addition to implants”.
“As far as we are aware, the product range included scab and prosthesis cushions, for instance. As a result, there was no evidence suggesting that the products delivered by Brenntag could be intended for use in the human body,” it added.
In addition, medical device manufacturers are subject to government supervision, said Brenntag, adding in its statement: “Brenntag could therefore assume that PIP, a leading certified provider of medical devices, would be supervised accordingly by the French health authorities. As far as we are aware, the French health authority, Afssaps [French Agency for the Safety of Health Products], never found fault with PIP and its products during the entire delivery period.”
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