On 7 February 2012 American journalist Naomi Wolf was a guest on the BBC’s program Newsnight. She was shocked and appalled to hear Health Minister Anne Milton respond to the questions of twenty five women who had all been fitted with PIP implants and who were all understandably worried and confused.
She watched in disbelief as Ms Milton told the women that, “The evidence to date is that they [PIP implants] are not [dangerous].” Surely she must have heard wrong? Surely the UK Health Minister could not have uttered those words in the face of such overwhelming evidence to the contrary?
In 2010 PIP implants were banned from the EU market due to concerns about their safety. Though the French Authorities recommended that all PIP implants be removed as a precaution, the British government did not follow suit. In addition to concerns about the grade of silicone used and the higher rupture rate of PIP implants, the World Health Organisation also advised that French Authorities had reported that the industrial grade silicone could irritate surrounding tissue and could cause pain and inflammation if it leaked into the body.
Ms Wolfe wondered if it was possible that the British Health Minister hadn’t received the global alert issued by the World Health Organisation. Surely an oversight of that magnitude just couldn’t happen? Yet it seemed that she was denying any knowledge of the dangers associated with the implants.
In 1991 Ms Wolf wrote a book called The Beauty Myth: How Images of Beauty Are Used Against Women. In it she explores the idea that as women have gained power and recognition in society they have been under increasing pressure to conform to a certain standard of ‘ideal’ physical beauty. As part of the research for her book she read many medical journals including the British Medical Journal. She was horrified to discover that while the journals were publishing articles about the frightening side effects of silicone implants and high rupture rates, the glossy magazines bought and read by hundreds of thousands of women were simultaneously extolling the life-changing benefits of breast augmentation.
Even in the early nineties there was information available in the medical arena detailing problems such as the fact that ‘up to 70% of implants would harden “like golf balls”’, a rupture rate of ‘30-70 %’ and the ‘unknown consequences’ of silicone escaping into body after rupture. In 1992 silicone breast implants were actually banned in the United States by the Food and Drug Administration (FDA).
Nonetheless, in spite of the existence of all this information, British women are now in a situation where they have been fitted with PIP implants but are only now being told about the dangers of the silicone filler. The question on Ms Wolf’s mind was how this was ever allowed to happen. Why didn’t the government step in and prevent private clinics from making a fortune from fitting defective medical products?
This is an especially pressing issue given that the NHS is now having to pick up the pieces for women whose clinics are not offering them any help. Thousands of women are now depending on the NHS to provide them with MRI scans to check for ruptures and removal surgery which will cost the NHS millions of pounds.
In response to Anne Milton’s ‘jaw-dropping statement’ on the Newsnight program, Ms Wolf was unable to contain herself and blurted out that the health minister was either “lying or else in the wrong job”. It seems completely implausible to think that the Cameron government couldn’t have been aware of the 1992 FDA ban.
In 2006, as a result of aggressive lobbying by the industry, the FDA lifted its ban. However it imposed a condition on breast implant manufacturers as part of the agreement to approve their products. Manufacturers promised to keep track of the 80,000 women fitted with implants so that they could monitor their health over a period of 10 years. According to a report by Saundra Young on CNN in 2011, Mentor and Allergan had only managed to follow-up 21% of recipients. Clearly FDA conditions were not being met and it is worrying that the US government adopted this ‘implant now, study later’ policy.
In 2011 Dr Edward Melmed, a plastic surgeon from Dallas, told the FDA that silicone breast implants were an “industrial toxin” which were “guaranteed to fail [in] 80% [of cases] in 10 years”. When the FDA lifted its ban on silicone breast implants in 2006 he spoke out against them in the US media, with an article published in the LA Times in 2007 called “Silicone Implants: They’re Still Dangerous”.
It’s not just a matter of silicone – breast implants also contain denatured alcohol, epoxy resin, acetone, naptha rubber, polyvinyl chloride and talcum powder. When implants rupture and these substances enter the body it’s no wonder that they cause significant health problems. Dr Edward Melmed has fitted thousands of women with breast implants since they were first introduced in the 1960s and has noted common problems associated with them including capsular contracture (hardening over time), the likelihood of pain and disfigurement and the high rupture rate. He has seen a “disturbing” number of women with symptoms such as joint and muscle pain, hair loss, fatigue, depression, skin rashes, memory-loss and insomnia.
In the past 14 years Dr Melman has removed implants from 1000 women. Despite his best efforts to remove any obvious silicone in cases where the implant has rupture – in lymph nodes for example - he admits that “We are still not sure of all the places where the micro-droplets of silicone end up”. He also notes that whilst “every generation of silicone implants have been heralded, like this one, as an improvement” we are a long way from knowing what the ultimate health consequences for health are.
So are women effectively acting as “experimental lab rats” for these implants as Dr Melman suggests? When the manufacturers themselves say that one in four women will need further surgery within the first year of having implants fitted and that many will require multiple operations over time, why did no one warn them of the dangers?
Wolf suggests that financial interests work to prevent manufactures from conducting adequate tests. In turn the very nature of the defective products means that women will find it necessary to have further procedures thus guaranteeing private clinics a future income from their patients. As a result of willful ignorance and a reluctance to divulge what facts are known, coupled with highly-strategic marketing campaigns, thousands upon thousands of women across the globe have been failed by those who could have protected them.
So what has the FDA done about the fact that manufacturers failed to uphold their end of the bargain? Nothing. It has said it will ‘think about the situation’ and consult with surgeons and patients. So the vested interests in not keeping clinical records so data could be studied seem to have won out against the FDA’s purported mission to protect the safety of patients.
As Ms Wolf says in her article published in the Guardian on 15 February 2012, as a result of the power exerted by stakeholders at the expense of women’s health a whole ‘new generation of women will not have access to critical government studies that would otherwise confirm the overwhelming evidence of health problems associated with silicone implants.’ That our Health Minister could appear on national television and say that there is no evidence to suggest that PIP implants are dangerous is beyond insulting. It’s an outrageous affront to those women affected. This remains the official view on the matter - routine removal is still seen as unnecessary by the UK panel of experts convened to investigate the health risks of PIP implants.
Wolf concludes that the government must think women are either “really stupid or really worthless” in order for us to have reached this point. They have failed so spectacularly to protect women against those who seek profit at the expense of their health and - adding insult to injury - their actions now suggest that they do not believe women deserve accountability.
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