The revelation that up to 50,000 women in the UK may have defective breast implants containing industrial-grade, rather than medical-grade, silicone from the French company Poly Implant Protheses (PIP) has led to a public outcry and shone a light on the seedier side of the booming cosmetic surgery industry. In December, the death of a 53-year-old woman who had the controversial implants from malignant lymphoma sparked a health scare. But the fact that allegedly faulty implants were being used so widely also suggests a bigger issue within the industry. It raises questions not only about the quality of the information out there but also over the standard of safety regulations. So what are the health and environmental risks associated with cosmetic procedures and which areas of the industry need scrutiny?
Silicone has something of a chequered history. Health scares have occasionally occurred, with one in the early 1990s prompting its temporary withdrawal from the US market. It has never been withdrawn in the UK however, and today, the industry generally considers it to be safe. A speedy review from the Department of Health into PIP concluded that there is in fact no link between the PIP implants and cancer, and health guidance from the Medicine and Healthcare Products Regulatory Agency [MHRA] states the same is true for medical-grade silicone implants. A significant amount of weight is added to these claims by a report from America's Food and Drug Administration, which reviewed scientific literature from January 1997 to May 2012 on anaplastic cell lymphoma and concluded that there was no evidence to suggest that silicone implants cause the cancer. But that doesn’t mean implants are entirely risk-free.
When it comes to implants, be that breast or buttock, some risks are known for sure. These include implant failure, capsular contraction (an immune response that seals off silicone into lumps, isolating it from the rest of the body), nerve damage and silicon leakage. Leakage of silicone into the lymph nodes has been one of the key concerns raised by the PIP scandal. But according to consultant plastic surgeon and former British Association of Aesthetic Plastic Surgeons [BAAPS] president Douglas McGeorge, these leakages don't pose a serious risk to health. ‘Sometimes silicone can breach the capsule and create lumpy areas, but it doesn't go all around your body and give you silicone poisoning as many people would have you believe.’
However, Ilena Rosenthal of the Californian implant awareness group the Humantics Foundation, says that the current scandal bears similarities to previous scandals where patients have received implants filled with risky or dangerous substances. Indeed, the real safety concern lies in the standard of regulation for practices such as these. Following its enquiry into the PIP affair, the Department of Health has raised some questions over the information available. It states: ‘It's clear from the information we have received from the industry that the safety information it has provided to the regulator is patchy. Without good data, we have no way of knowing when problems arise.’
This is an issue that Debi Sandler, founder of online information hub Cosmetic Support, has been working to combat for 12 years. But she argues that not only is there a lack of information available – there's also an unhealthy dose of misinformation. A 2010 review by the National Confidential Enquiry into Patient Outcome and Death, a UK watchdog, highlighted serious concerns over clinics and surgeons. More than two thirds of clinics refused to reply to questions, despite legal obligation to do so. Of those who did respond, only 44 per cent of operating theatres were adequately equipped, little training was offered, and two-thirds did not offer psychological assessment for the patient.
Fillers - the next big scandal?
There is also growing concern over the classification and regulation surrounding fillers - and the safety implications this involves. Indeed, Sally Taber, director of the Independent Healthcare Advisory Services organisation recently said that fillers would be the next scandal to hit the industry unless action is taken immediately. In October 2010, the UK passed a bill that de-regulated injectable cosmetic procedures, meaning they could be cosmetic fillers can be purchased and injected by anyone, even those with no medical training. ‘Some fillers are much safer than others,’ says Tamara Griffiths, a consultant dermatologist for the British Association of Dermatologists. ‘There are two main types - permanent and temporary fillers. Permanent fillers have been well-documented in medical literature to cause problems, and they may not develop until years later. There's a higher potential for a reaction to a foreign body and that's very difficult to control - it can be debilitating, it can be unpredictable, and it can be long-term. Temporary fillers, such as hyaluronic acid and collagen, have a better track record on safety, but even these are not inert.’
And this is why, Griffiths argues, they should be classified as a medicine, not a medical device as the current classification does not accurately reflect the dangers involved. ‘The anatomy of the face is extremely complex,’ she says. ‘These are medical procedures with a cosmetic implication.’ She adds that if someone hasn't had the relevant medical training, they could unwittingly causing damage. It's a ‘minefield’ in terms of what's available, she says. And in any case, there's always a risk regardless of the brand you choose. ‘With any type of filler, there's a risk that you could inject into a blood vessel or around a blood vessel by mistake and the blood vessel closes off, so the skin will be starved of oxygen. It can potentially cause permanent scarring.’
Dangers also surround the use of Botox, or botulinum toxin. ‘The issue with botulinum toxin is that it's made with human albumin, a blood protein,’ explains Nigel Mercer, consultant plastic surgeon and another former BAAPS president. ‘And you need to be sure human albumin doesn't have CJD [the human form of mad cow disease]. Every woman who has Botox needs to know they're being injected with foreign human protein. Basically, anything that's made with blood carries a risk for the patient. But very few people who go to a high street clinic are told it has human albumin in. We would also always recommend that women of childbearing age don't have foreign blood products given to them because you carry a foetus that's a different blood group from you and you don't want to become allergic to foreign protein.’
Concerns over the boob jab
Something else causing concern is the boob jab (Macrolane). ‘There have been some horrendous complications [with Macrolane] right from the outset,’ says Mercer. ‘I don't use it because it's not a good idea. I've never thought it was a good idea.’ Problems can include permanent lumps in the breast, uneveness, infection and permanent swelling. Macrolane is made from hyaluronic acid - a substance that occurs naturally in the body. Mercer's concern is that there is always a serious risk associated with anything you inject but despite this Microlane is one of the substances licensed as an implant, not a medicine.
Surgery and the planet
The environmental impact of producing and disposing of cosmetic devices and substances is difficult to determine. Paul Whitehouse, a research scientist for the Environment Agency, says some research has been done on silicone - which only becomes hazardous when it is broken down. ‘Over a period of time under heat the silicone polymer can break down into its constituent monomers - cyclic siloxanes. They're abbreviated to D4, D5 and D6,’ he says. ‘D4 has been classified as Persistent, Biocumulative and Toxic, which means it hangs around in the environment, is taken up easily by plant and animal tissues and it would have a measurable adverse effect on an organism.’ But, he says, ‘it's hard to see how they would find their way into the environment from this particular source.’
Silicone implants are disposed of through medical incineration, which Whitehouse explains would turn virtually everything to CO2 and silicon dioxide (which is inert), and that the monomers are unlikely to survive. Still, carbon footprint is difficult to pin down, as it doesn't seem to be a standard measurement in the industry. UK implant manufacturer Nagor, for example, was unable to offer an estimate because it is not something the company measures.
With so little solid data around this area, it is hard to judge what sort of real impact the industry is having on the environment. But we can only hope that here, at least, processes are tight. As Mercer says, ‘with good CE markings, one hopes producers work in good environments and follow all the production regulations that exist in the UK and Europe. The PIP scandal shows that if you get a crook involved you have problems.’
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