Wednesday, 28 December 2011

PIP Breast Implants – A Defective History for a Defective Breast Implant

Article by
Kevin Timms
In the year 2000 the Food and Drug Administration (“FDA”) in America raised concerns about the manufacturer, PIP, who made PIP silicone breast implants with industrial grade silicone, potentially affecting hundreds of thousands of women globally. PIP breast implants have been at the centre of extensive media attention recently.

At the turn of the millennium the FDA sent an investigator to inspect the manufacturing site in the south of France in May 2000. Subsequently, the FDA wrote to the founder of PIP, Jean-Claude Mas, with a warning stating that the implants were “adulterated” and listing at least 11 deviations from good manufacturing practices.

These problems were in respect of PIP Hydrogel breast implants; however, this is relevant as it was the same factory where PIP silicone breast implants were manufactured. A number of legal claims were made in the UK over the PIP Hydrogel breast implants but PIP had inadequate insurance to cover those claims and Judgments remain outstanding.

However, it is unclear as to why the FDAs warning letter did not trigger greater scrutiny of PIPs activity by the medical device regulators in France and elsewhere (including the UK). AFSSAPS, the French medical device regulator told Reuters that it had not found evidence that the FDA had informed them of the letter sent to PIP.

The FDA warning letter, sent in June 2000 confirmed PIP failure to investigate the deflation of its saline breast implants and failure to report more than 120 complaints in France and elsewhere to the FDA. The letter further stated that PIP did not have a process in place to make sure the breast implants it manufactured met design specifications.

If you have PIP silicone breast implants please sign up to the National PIP Breast Implant Register.

If you are interested in making a PIP Breast Implant Compensation claim please contact Kevin Timms on 01992 422 128 or email Kevin at kevin@gardenhousesolicitors.co.uk.



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http://www.gardenhousesolicitors.co.uk/ Tel: 01992 422 128

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