In 1996, Trilucent breast implants, approved by the MHRA, were heralded as the latest breakthrough in breast implants! Made from natural soya so if it ruptures, your body will absorb soya naturally. In 1999, the MHRA subsequently banned this breast implant. It was found to be mutagenic and carcinogenic in rats. Interestingly this implant was an American implant that could only get CE/MHRA approval so sold 5000 implants to Europe and only 50 were used in the US for testing purposes only. Has the UK and Europe become the new laboratory grounds for pre-testing of US products with its lax European regulations for CE marks and a UK MHRA which automatically accepts a CE mark for the UK market? The UK market for medical devices was quoted by the MHRA in 2009 as £7 billion!
Then came Hydrogel breast implants, approved by the MHRA, and manufactured by PIP Cloverleaf in the UK. Yes, that's right, a UK manufacturer of breast implants! This too was pitched as the latest breast implant made from sugar water so perfectly safe. Non-silicone implants are superior to silicone which interferes with mammograms to screen for breast cancer was the message conveyed to the consumer. In 2007, MHRA announced a voluntary recall.
Then we have French PIP breast implants, approved by the MHRA based on a CE mark, distributed in the UK by the same company PIP Cloverleaf. Heralded as cohesive silicone gel so less likely to rupture and leak. Also comes in a special tear-shaped design so it looks most natural. Recommended in ladies with previous ruptures. In 2010, the MHRA banned PIPs.
So over the past decade, the MHRA appears to have a 100% failure rate in successfully approving breast implants that will not subsequently get banned or recalled. Why did the MHRA approve breast implants that failed inspection by the US FDA? Why did the MHRA ignore evidence from the US FDA that in March 2000, 11 deficiencies were found in good manufacturing processes at the French PIP factory? Why did they not take into account that all 3 implants failed to pass US FDA inspection. There had to be valid reasons? Was it simply because CE marks give automatic UK MHRA approval for the UK market?
US FDA
The US Food and Drug Administration is the only global independent regulatory body for medical devices who has had a 100% success rate in identifying which breast implants are not up to standards. The US FDA denied applications made by Trilucent, by Hydrogel and by PIP. 100% accuracy rate! No ladies in the US suffered as a result of there stringent regulatory testing processes which take an average of 54 months to complete vs the EU's 11 months. It does not give 2 weeks notice of a site visit, as does the MHRA. The global market for medical devices is £200 billion. Because of the high litigation rates which ensures accountability in the US, the US FDA has to be more stringent and rigorous in their testing and follow up to ensure patient safetyhttp://www.conservativehealth.org/index.php/menublog/109-pip-implant-accountability-health-bill-does-work
