The Warnings ....

PIP prostheses: could anyone stop the scandal earlier?

Ten years have elapsed between the first warning and removal of PIP implants from French market. Why the French authorities did not before they react? 

    Even before the scandal PIP implants in France, these implants were banned in the U.S. market. While complaints against PIP accumulate, victims wonder whether the defective implants scandal could have been avoided. Or at least be detected earlier. Some signals left, in fact, predict significant breaches of basic health rules

Don't panic about breast implants, says France as it's revealed U.S. warned manufacturer 10 YEARS before scandal broke
28 December 2011    It has emerged that in 2000 the U.S. Food and Drug Administration warned him about 11 deviations from ‘good manufacturing practices’ at PIP’s plant in La Seyne-sur-Mer in the south of France. Read more 

Insight: FDA warned PIP on breast implant safety in 2000 Read more 

The ministry warned in 1996 about PIP

According to our information, they came very early, in 1996, were directed to the Department of Health (then called Social Affairs). He had been warned by anonymous letters on abnormalities in PIP, an inspection was conducted, rates of abnormal breaking records and the floor of Toulon had even been entered. Then the case was carefully closed until 2010 ...Three inspectors visit the site for the first time and meet Jean-Claude Mas, founder and patron, September 9, 1996. Then two other letters then arrive at the Ministry on 13 and 16 September 1996, stating a little more dysfunction in PIP. Obviously, the informant is knowledgeable. Three inspectors, two of Fraud and the Drass, returning twice 4 and 11 October 1996 Read more;

French watchdog 'did not act fast enough on faulty PIP breast implants'

Report shows agency knew of dangers of substandard silicone prostheses in 2006 but did not prevent their use until 2010. Mediapart reported that the French watchdog had learned of an increased risk of the implants rupturing in 2006. The implants were taken off the market in 2010, but Mediapart said the report suggested the watchdog could have acted as early as 2007 or 2008 and prevented thousands more women having the implants
Read more

A conviction in 2007 in Britain
The second warning comes from Britain. In 2007, hundreds of Britons now complain against breast implants for "defective prostheses (leak silicone gel)." The company is ordered to pay 1.4 million euros. Asked by Le Parisien about it, AFSSAPS assured once again not having been informed of this decision.  
Read more;

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Pips breast implant scandal: Regulator warned years earlier

            Surgeons contacted the Medicines and Healthcare products Regulatory Agency in 2006 to highlight concerns that the PIP implants were splitting more frequently than other brands of implant, the report by health minister Lord Howe said. Read more here 

2000-   In March 2000, the US Food and Drug Administration (FDA) refused to approve a different type of implant, filled with saline, which was produced by the company.Three months later, the FDA issued a warning that implants had been found to be adulterated, and that 11 deviations from “good manufacturing practices” had been found during a visit to the PIP plant.

2002 -The review found that the MHRA began to receive reports of potential problems with PIP implants in 2002, almost a decade before the scandal broke in December

2006- Ruth Waters  was so alarmed that she too wrote a case report, published in the same journal. She had never come across PIP implants before, and had urged her patient to sue the manufacturer and the clinic for negligence.Learn more here 

2007- That letter appeared more than four years ago in 2007, long before the authorities woke up to the PIP scandal.Mr Berry wrote in his letter: “That a high cohesive gel implant could have suffered such a massive failure only three years after implantation is very worrying ... the reliability of PIP implants must be questioned and, for myself, I intend to discontinue their use in favour of implants from other manufacturers.”

2009- In February 2009, Mark Harvey, the head of litigation with Hugh James solicitors in Cardiff who has about 350 possible claimants in a class action, had become so alarmed by the growing number of complaints landing on his door step, that he wrote to the MHRA,He has no idea if those warnings were ignored for another year and more, during which time many more women would have received the substandard implants. “When I first went to the MHRA I was brushed off,” said Mr Harvey, “I told them I had been instructed in a number of cases with remarkably similar stories. At the time they just told me they had had no other reports.”

• Breast Implants: The Truth Behind the Scandal  Concerns was filed with the The UK MHRA in 2009 when a lump was found during a mammogram and ultrasound scan in a female patients breast but no action was taken by MHRA at the time. Read more;

Director's post at the MHRA, whose occupant would have had strategic oversight of medical devices such as implants, was vacant from September 2010 until February 2012.
Read more 

Scotland's top plastic surgeon raised alarm over dangerous breast implants five years ago
EXCLUSIVE:One of Scotland’s top plastic surgeons warned health watchdogs about dangerous breast implants FIVE YEARS AGO, we can reveal today. Awf Quaba told medical authorities of the abnormally high failure rates in the French-made implants in 2006 – shortly before his hospital stopped using them completely Quaba wrote to both the MHRA and the French manufacturer in 2006 before banning the implants at Edinburgh’s private Spire Murrayfield hospital, where he carries out most of his work, in 2007.“We did everything we could to raise the issue. In 2006, we reported our findings to the regulator as well as the maker and UK distributor.  The maker and distributor blamed implanting surgeons. We were unhappy with their explanation, and took the decision in early 2007 to stop using PIP at Murrayfield Hospital. Read more


Cosmetic surgeon concerned over 'guinea pig' patients
14 November 2010     Her relief at being told she did not have cancer was tempered by anger at the discovery that the silicon in her implants had leaked and spread into her lymph nodes. "I'm outraged and upset," she told the BBC's 5 live Investigates programme. "I have to live with that in my body for the rest of my life. No-one can actually tell me if that's going to be a problem in the future or not."Ms Kidd says she raised her concerns with the MHRA in 2009 but no action was taken at the time.  Read more 

Breast implant scandal: the whistleblowers 

Brook Berry alerted colleagues to worries about PIP implants in a 2007 letter to the British Journal of Plastic Surgery. In February 2009, Mark Harvey, the head of litigation with Hugh James solicitors in Cardiff who has about 350 possible claimants in a class action, had become so alarmed by the growing number of complaints landing on his door step, that he wrote to the Medicines and Healthcare products Regulatory Agency (MHRA) – the body that took over from the MDA – to alert them to a possible problem.“When I first went to the MHRA I was brushed off,” said Mr Harvey, “I told them I had been instructed in a number of cases with remarkably similar stories. At the time they just told me they had had no other reports  ”Read more;

PIP breast implant fears surfaced seven years ago as women await report 
 6 Jan 2012    British women could also have received Rofil M implants, which were produced by PIP and used in overseas clinics.PIP is also said to have failed to inform their insurers of hundreds of complaints from clinics and surgeons.It emerged today that tests taken as long ago as 2005 raised safety concerns about the PIP implants. In a letter sent to PIP in 2006 by the insurers and seen by Sky News it is claimed PIP had received 4,000 claims by 2005 – but they only knew of four complaints. Read more