The Silicone Breast Implant Scandal

By Naomi Wolf, Guardian UK

16 February 12

have heard, in my life, many implausible statements from government officials, but never have I heard or seen anything quite as egregious as what I witnessed as a guest on the BBC's Newsnight program on 7 February 2012. Twenty-five frightened and suffering women had agreed to appear in the studio to ask questions of Anne Milton, a health minister for the UK coalition government. They had all been implanted with PIP (Poly Implant Prothèse) breast implants, which had been withdrawn from the EU market in 2010, after revelations of high rupture rates and confirmation that substandard – believe it or not, industrial – grade silicone had been used.

In December of 2011, French authorities advised that these PIP implants be removed; other countries' health authorities took similar action. Britain was not one of them. French authorities, according to the World Health Organization global advisory, "also found that the gel containing non-approved silicone was an irritant to tissue, and when leaking could give rise to inflammation and pain."

When I was researching The Beauty Myth, in 1991, I was reading British medical journals that informed me about the terrible health problems caused by silicone breast implants. I was shocked to see that even as women's magazines were promoting the hell out of them, the medical journals – which women would not see – were offering doctors insurance on implants because the rate of rupture was 30-70%. The side-effects were right there in the journals: up to 70% of implants would harden "like golf balls" and rupture, sending silicone into parts of women's bodies, with unknown consequences.

Similar warnings paid off in the US: silicone implants were banned in 1992. But Britain never followed suit. Now, though, British women like the ones in the Newsnight studio are facing the nightmare that they were never informed of the dangers of silicone by any government body, even as private, Harley Street doctors made fortunes continuing to push implants. And now, with the PIP scare, the NHS is faced with providing millions of pounds' worth of care to remove the implants and give women MRI scans to check for ruptures. It is in this context that I was astonished to hear the health minister say these words to a roomful of scared women:

"The evidence to date is that they [PIP implants] are not [dangerous]."

I couldn't believe my ears, particularly as her department would unquestionably have received the WHO's global alert detailing the PIP implants' greater risk of rupture and tissue-irritant properties of the gel, so I informed her before we taped that the FDA had taken them off the market in the US in 1992, after decades of concerns raised, lawsuits and studies. The FDA's ban had held for 14 years, eventually lifted thanks to industry lobbying in 2006. Nonetheless, Milton repeated her jaw-dropping statement to the panel of women seeking MRIs, the removal of the implants – and just some basic answers.

I confess I blurted out at that point that she was either lying or else in the wrong job. It is inconceivable that the Cameron government – and she herself – did not know about the 1992 FDA ban, which was reported globally. Given the millions of pounds in liability that the government is trying to deflect, it is utterly not credible that she would have not been advised of the nature of that liability; the data on the health risks are unmissable: "If you Google 'silicone breast implant health problems'," I suggested to her; a simple search will give you 14 million results.

In 2011, Saundra Young, reporting on CNN, noted that Mentor and Allergan told the FDA that they had lost track of many patients after implantation. They had promised the FDA that, as a condition of the agency's approval of their implant products, they would follow up with the women who had received them, but – oh dear! – they could only keep track of 21% of those women. In 2009, 318,000 breast implant procedures were done in the US, 70% of those using silicone. Breast implants introduce into your body substances such as denatured alcohol, naphtha rubber, epoxy resin, polyvinyl chloride, talcum powder and acetone, in addition to silicone. Dr Edward Melmed, a plastic surgeon from Dallas, told an FDA panel in 2011 that the implants were an "industrial toxin".

"The symptoms, they are real," he said. "I answer five to seven emails a night from women all over the world, asking, 'What do I do about these symptoms?'"

Melmed told the FDA that by 10 years after patients get them, 50% of silicone implants have ruptured; 72% by 15 years; and 94% rupture by 20 years:

"Why is the FDA continuing to allow a device to be placed in young women that is guaranteed to fail [in] 80% [of cases] in 10 years? Would they allow that in hip replacements? Would they allow it in men?"

Dr Melmed is something of a prophetic figure: a Dallas surgeon who had inserted breast implants in thousands of women, he wrote in the LA Times, in 2007, in "Silicone Implants: They're Still Dangerous", after the FDA rescinded its 1992 ban.

Dr Melmed had enlarged the breasts "of thousands of women with silicone implants since they were first introduced in the 1960s". But he described his patients' appearing with a common problem over time:

"Most breasts with silicone gel implants become hard with time. It's called capsular contracture … Women with capsular contracture often end up with disfigured breasts and pain."

He described patients such a Helen S, 71, whose implants from 23 years earlier had hardened and were causing her pain. An MRI revealed that the implants had ruptured and calcified: "When I removed the implants, the cavity was filled with gooey, liquid silicone that had ruptured; there was virtually no implant wall left." In the past 14 years, he has removed the implants from 1,000 women; he adds, "We are still not sure of all the places where the micro-droplets of silicone end up, though I have found it in lymph nodes."

He points out that every generation of silicone implants have been heralded, like this one, as an improvement. This time, he noted in 2007, the FDA is requiring women to get monitored for rupture with MRIs, and advises replacement every ten years. "It is a pity that women will become the experimental lab rats for these implants," he notes, and points out that they, not the surgeons, will have to pay for the expensive monitoring. Other surgeons aggressively deny any connection between silicone implants and health problems, but Dr Melmed attests:

"I have seen a disturbing number of patients with symptoms, including fatigue, short-term memory loss, joint and muscle pains, skin rashes, disturbed sleep patterns, depression and hair loss, that clear up when implants are removed."

The implant manufacturers' own literature warns that one in four women will need additional surgery within the first year after getting implants, and many will have multiple surgeries. "Women deciding to have these implants need to be prepared to have additional surgery," cautions Dr Daniel Schultz, head of the Center for Devices and Radiological Health at the FDA.

The women in the BBC studio in London were horrified that no one had told them about the dangers. They kept saying, understandably, "How could the government allow this to happen?" They kept asking, "Where are the tests?"

The tests have not been done because of financial pressures not to know and not to tell women what dangers await them. The real boondoggle is not that it costs under $600 in the UK – a relative bargain – to get silicone breast implants; it's that it costs $3,000-8,000 to remove them, or to have repeat surgery for ruptured or hardened implants. The very defective nature of the implants – about which women are not adequately informed – guarantees a surgeon lucrative future procedures from that same woman, as her implants harden and rupture over time.

The "Oops, we forgot to tell you what these things do to you" approach extends to the US. In 2007, when implants were pushed back on the market, the FDA – seeking to appease the chemical industry and the surgeons' lobby – compelled manufacturers, as a condition of approval, to spend a decade studying the 80,000 women who were now being given implants. This was bad enough; as Dr Melmed puts it, at that time, the government's policy was implant now, study later. At the rates that women are seeking breasts implants, five US women in every 100 will have the devices in their bodies in a decade.

So, what has happened since? Surprise: the manufacturers failed to follow through, but sold the hell out of the devices anyway. There are strong vested interests in not compiling this data for the purpose of government scrutiny; indeed, the US and the UK authorities are cynically looking the other way. The FDA's response to the industry's failure to comply with the clinical record-keeping it had undertaken as a condition of the lifting of the ban has been merely to note that it would think about this situation and not take any action without consultation with, creepily enough, surgeons, patients and "sponsors". Before the FDA was wholly owned by special interests, its mission was to protect the safety of patients, not to appease financial stakeholders.

So, a new generation of women will not have access to critical government studies that would otherwise confirm the overwhelming evidence of the health problems associated with silicone implants. Why is it always women who are treated as guinea pigs and their bodies like lab rats'? I guess because there is a cultural assumption, which, in effect, the UK government deployed last week in public, that women deserve no accountability, especially if you can blame the issue on their "vanity". Anne Milton and her colleagues in the Cameron government must think women are either really stupid or really worthless, since they – like my own government – apparently feel no obligation to protect women from special interests profiting at the expense of their health.