Report shows agency knew of dangers of substandard silicone prostheses in 2006 but did not prevent their use until 2010
theguardian.com,
PIP founder Jean-Claude Mas stood trial earlier this year; he could face five years in jail. Photograph: Eric Estrade/AFP/Getty Images
The French state medical watchdog did not act fast enough on reports of faulty breast implants marketed by the company Poly Implant Prothèse, allowing thousands of women to continue having the substandard silicone prostheses fitted at a potential risk to their health, according to an internal document seen by the investigative website Mediapart.
The discovery that the French firm PIP, which at one time was the third-biggest global supplier of breast implants, had been cutting costs for 10 years by using an illegal, untested, home-made concoction of industrial-grade and agricultural silicone instead of medical silicone approved for humans, sparked an international scandal.
Jean-Claude Mas, the firm's founder, and four of his senior staff stood trial earlier this year over the botched implants which were sold from 2001 to 2010. They were accused of aggravated fraud and cutting costs by using the concoction in most of the PIP implants that were sold around the world. It was one of the biggest trials ever held in France and a verdict is expected in December. Mas could face up to five years in prison.
It is estimated that more than 300,000 women in 65 countries may have had PIP implants fitted, including in reconstruction surgery after cancer. About 47,000 women in the UK have had PIP implants, just under 900 on the NHS, mostly for post-cancer breast reconstruction. In France, nearly 15,000 women have chosen to have their implants removed or replaced. At least 4,000 reported PIP implants rupturing.
At the time of the trial, lawyers for women who had the implants said the French health authorities responsible for monitoring implants should be in the dock as well for failing to prevent the scandal. France's medical safety watchdog, then named Afssaps, has been criticised by the victims for not acting fast enough.
But the Mediapart investigation, which quotes from a confidential international report highly critical of Afssaps's handling of the case, said this was the first time an internal document has flagged up the fault of the agency.
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.
Philippe Courtois, lawyer for the French PIP victims, told France Inter radio that many felt it was "shameful and scandalous" that the agency could have acted earlier and demanded the watchdog be placed under formal investigation by the state.
Dominique Maraninchi, head of the medical watchdog, now renamed ANSM, said a full public report in 2012 into the agency's role had been sufficient. He denied any cover-up or dissimulation.
In December 2011, the French health ministry advised women with PIP implants to have them removed as a precaution, cautioning that, while there was no proven cancer risk, they could rupture. Last year, medical experts investigating the consequences of the PIP scandal in the UK concluded that the substandard silicone gel did not pose a significant risk to women's health in the long term.
The discovery that the French firm PIP, which at one time was the third-biggest global supplier of breast implants, had been cutting costs for 10 years by using an illegal, untested, home-made concoction of industrial-grade and agricultural silicone instead of medical silicone approved for humans, sparked an international scandal.
Jean-Claude Mas, the firm's founder, and four of his senior staff stood trial earlier this year over the botched implants which were sold from 2001 to 2010. They were accused of aggravated fraud and cutting costs by using the concoction in most of the PIP implants that were sold around the world. It was one of the biggest trials ever held in France and a verdict is expected in December. Mas could face up to five years in prison.
It is estimated that more than 300,000 women in 65 countries may have had PIP implants fitted, including in reconstruction surgery after cancer. About 47,000 women in the UK have had PIP implants, just under 900 on the NHS, mostly for post-cancer breast reconstruction. In France, nearly 15,000 women have chosen to have their implants removed or replaced. At least 4,000 reported PIP implants rupturing.
At the time of the trial, lawyers for women who had the implants said the French health authorities responsible for monitoring implants should be in the dock as well for failing to prevent the scandal. France's medical safety watchdog, then named Afssaps, has been criticised by the victims for not acting fast enough.
But the Mediapart investigation, which quotes from a confidential international report highly critical of Afssaps's handling of the case, said this was the first time an internal document has flagged up the fault of the agency.
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.
Philippe Courtois, lawyer for the French PIP victims, told France Inter radio that many felt it was "shameful and scandalous" that the agency could have acted earlier and demanded the watchdog be placed under formal investigation by the state.
Dominique Maraninchi, head of the medical watchdog, now renamed ANSM, said a full public report in 2012 into the agency's role had been sufficient. He denied any cover-up or dissimulation.
In December 2011, the French health ministry advised women with PIP implants to have them removed as a precaution, cautioning that, while there was no proven cancer risk, they could rupture. Last year, medical experts investigating the consequences of the PIP scandal in the UK concluded that the substandard silicone gel did not pose a significant risk to women's health in the long term.
