Is Silicone safe?
In 1990 the Connie Chung "Face to Face" chat show in the United States featured a woman who claimed that her advancing crippling systemic disease was the result of a condition wrought by her breast implants. The allegations were part of a lawsuit against Dow Corning, a huge multinational chemical company for whom a small part of their business was manufacturing silicone rubber and silicone elastomer gel. During the subsequent controversy and investigations, irregularities in the way Dow Corning had conducted its research into silicones was alleged and the Food and Drug Administration effectively suspended the use of silicone filled implants for cosmetic breast augmentation.
On this side of the Atlantic as in the USA newspapers trumpeted the claims against silicone which included serious allegations about the risks of new cancer formation, damage to babies after breast feeding, and most insistently the risk of developing systemic scleroderma-like symptoms.
To the credit of our own health monitoring systems in the UK, as with other European countries, a more measured approach to the problem was adopted. Firstly it was recognised that despite the huge number of implants used over the preceding years, no pattern of new disease had emerged or been reported. In addition the lack of any god scientific fact was acknowledged, and thirdly, deficiencies in the monitoring of implant safety were identified.
The Medical Devices Agency responded to these observations. An implant register was established for the UK for breast implants and for all other implants. An adverse events reporting mechanism was set up, and research commissioned into the effects of silicone implants on patient health.
In the meantime many other manufacturers vied for the market share vacated by Dow Corning. A rush of alternative implants appeared on the scene. These included saline filed implants (allowed by the FDA despite their silicone shell), Soya oil filled implants (subsequently withdrawn amidst allegations of toxic breakdown products) and hydrogel (recently the subject of an alert by the MDA). Whilst lawyers, doctors and journalists joined battle in the US courts and feminist groups joined the fray, and a strange thing began to happen. Trial after trial of silicone implants began to report, and in almost all no significant difference in health outcomes was found for those with and without implants when corrected for confounding variables.
In 1998 the MDA’s Independent Review Group on silicone breast implants reported to the Chief Medical Officer that silicone gel breast implants are not associated with any greater health risk than other surgical implants, and that, whilst surgical complications do occur, no evidence for systemic disease could be found. They recommended that women undergoing such surgery should receive better information, something the responsible part of the profession was already committed to, and which is now enshrined in a government advisory leaflet to women.
The whole saga has left many observers bemused. Most plastic surgeons have maintained a firm commitment to the value of such surgery and to its scientific audit, whilst independent commentators have highlighted the ease with which science was hijacked for profit by several sectors of professional society. In her book Science on Trial, Marcia Angell, a former editor of the New England Journal of Medicine, provides a fascinating insight into this issue, summarised in Michael Fumentos "A Confederacy of Boobs" on the web.
In the wake of the storm a few facts stand out. Silicone implants are safe to the best of our current knowledge, and we now have a robust system for adverse event reporting and an agency for the evaluation of such medical devices. Several unsafe implant types have been removed from the market. The responsibilities of surgeons in this area are more clearly defined. Women have the right to choose this surgery and then to expect informed and careful evaluation and sensible measured advice.
Suggested Future Reading
The silicone controversy:
"Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case" Marcia Angell 268 pages Reprint edition (November 1997) W.W. Norton & Company; ISBN: 0393316726
The Medical Devices Agency:
The government’s advisory booklet for women considering breast implant surgery:
Professor Simon Kay, Consultant Plastic Surgeon