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Latest News | 15 May 2012

MHRA Working to ‘Quickly Implement’ Recommendations from Commission

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The UK’s Medicines and Healthcare product Regulatory Agency (MHRA) said it is moving to act on recommendations made by a Commission in the aftermath of a scandal involving breast implant products made [Read More...]

Tags: Breast Implant Howe Implant Improvement Keough Lansley MHRA NHS PIP report Review UK
Latest News | 14 May 2012

UK Publishes Review of PIP Breast Implant Scandal, Calls for Improvements

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The UK’s Department of Health (DOH) has released the result of a review into the Poly Implant Prothese (PIP) Scandal, finding the Medicines and Healthcare product Regulatory Agency (MHRA) to have [Read More...]

Tags: Breast Implant Howe Implant Improvement Keough Lansley MHRA NHS PIP report Review UK
Regulatory Update | 23 April 2012

Brazil: House Holds Hearing on Breast Implants

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The Commission on Social Security and Family of the House of Representatives held on 19 April 2012 a public hearing to discuss the situation of Brazilian women with silicone breast implants made by [Read More...]

Tags: Anvisa Brazil Breast Implant Commission of Social Security and Family Medical Device PIP Rofil
Regulatory Update | 11 April 2012

Brazil: New Brazilian Standards For Breast Implants

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The new Conformity Assessment standards for silicone in breast implants were released on 9 April by the Brazilian National Institute of Metrology, Quality and Technology (Inmetro).The standards permit [Read More...]

Tags: Anvisa Brazil Breast Implant Implant Inmetro Silicone
Latest News | 23 March 2012

Brazil’s Anvisa Introduces Additional Controls on Breast Implant Products

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Brazilian regulatory authority Anvisa this week became the latest health regulator to exercise greater enforcement controls over the sale and testing of breast implant products in the wake of a global [Read More...]

Tags: Anvisa Brazil Breast Implant Certification Implant Inmetro National Quality Control Instute PIP South America
Latest News | 19 March 2012

Dutch Regulatory Authority Echoes Warning on Faulty Breast Implant Products

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The Dutch Health Ministry is warning thousands of women about the risks associated with breast implant products manufactured by French firm Poly Implant Prothese (PIP) after becoming concerned about [Read More...]

Tags: Breast Implant Dutch Health Ministry Medical Device Netherlands PIP Rupture
Latest News | 9 March 2012

Amidst European PIP Scandal, FDA Approves New Breast Implant Product

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The US Food and Drug Administration (FDA) approved Sientra, Inc.’s breast implant product on 9 March, making Sientra the third approved marketer for breast implant products in the US.The approval [Read More...]

Tags: Breast Augmentation Breast Implant CDRH Cosmetic FDA Implant PIP SIentra
Latest News | 3 February 2012

EC Investigation of PIP Implants Inconclusive, Calls for Further Study

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A European Commission (EC) study of the breast implant products manufactured by French company Poly Implant Prothese (PIP) has come to inconclusive results regarding the rupture rate of PIP’s breast [Read More...]

Tags: Breast Implant EC European Commission France French Investigation PIP Poly Implant Prothese report Scandal Study
Latest News | 26 January 2012

PIP Executive Arrested in France, Could be Charged With Manslaughter

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Two former executives of the French company Poly Implant Prothese (PIP) were arrested on 24 January by French investigators, who may charge at least one of them with manslaughter for their role in a [Read More...]

Tags: Breast Implant France French Jean-Cloude Mas PIP Poly Implant Prothese Scandal
Latest News | 25 January 2012

MHRA Fires Back at The Lancet, Says Critics Lack "Clear Analysis of the Facts"

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Earlier this month, the British healthcare journal The Lancet published a series of scathing editorials that lambasted the medical device regulatory regimes of a number of European countries, and [Read More...]

Tags: Breast Implant Critics Editorial Lancet medical devices MHRA PIP Richard Horton Scandal The Lancet
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