Silicone Breast Implants -- Now Safe?
In 1992, the Food and Drug Administration convened on the subject of silicone breast implant safety, as reported by the Washington Post:
"...as the panel members spoke up one by one, it became clear that they were far from certain about the risks and benefits of the devices. The first scientist to speak quoted the prophet Isaiah and writers Ralph Waldo Emerson and Samuel Johnson before calling for more testing. The second said it was impossible for women to make an informed decision about whether to use implants because there was not enough information. The third complained that the issue should have been resolved years ago.Unable to agree on how to interpret the jumble of opinion, fragmentary data and scientific speculation, the panel members finally threw up their hands in frustration."
So reported Malcom Gladwell in "Breast Implants; After a Decade of Controversy, Key Questions are Unanswered and the Future of the Device is Unresolved", perhaps before he reached a tipping point, blinked, and got off that beat.
Since then, scientists have continued to debate the safety of silicone implants. While doctors and patients often say that compared to water implants "silicone implants feel more natural and look better", lawsuits against Dow Corning in the 1980's and 1990's linked silicone breast implants to breast cancer and various autoimmune disorders. The suits threw Dow Corning into bankruptcy protection, from which it emerged in 2004. Now, following several reports claiming the implants are safe, silicone breast implants look poised for renewed popularity.
Last year the Economist acknowledged that Dow Corning that it had "earn[ed] a lifetime achievement award for the courting of controversy", in "America's Most-hated Companies: The Very Bottom Line" (Dec 20th), but now, the company once routed by the legal repercussions of leaking breast implants , has reorganized, emerged from bankruptcy, paid out at least 3.2 billion dollars to plaintiffs, and is courted as a Wall Street "darling". Be that as it may, silicone implant safety is no less controversial then it was 15 years ago, but the FDA is now edging towards approving silicone implants.
Unfortunately, if silicone implants are approved, women will still be challenged in their quest to make informed decisions about implants. Who should they trust? Their surgeons? Scientific research in prominent journals? The FDA?
Research Showing Oxidized Platinum Leaked Into Implant Recipients, Retracted by Dow Chemical Following Complaints by Manufacturing Companies
If women turn to the internet for safety data, they will quickly find reassuring answers from sites like LookingYourBest.com, or CosmeticSurgeryTimes.com. The latter site features interviews with bronzed, well-fed doctors who urge you that their highest concern is women's safety. A more time consuming search turns alarming news, such as the recent, controversial paper in the journal Analytical Chemistry, widely covered in the national press.
The journal published a paper on silicone breast implants last May which provided evidence of platinum leakage from the implants. The authors proposed that the blood, urine and hair of 18 of 23 women who had implants contained higher levels of platinum then the controls. (Lykissa, ED and Maharaj, 2006. Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-ICPMS. Anal. Chem. 78:2925-2933). Lykissa and Maharaj asserted that the platinum was found in oxidized reactive states, states that are associated with toxic physiological affects.
One the heels of that publication, Analytical Chemistry then published two articles that criticized the study and journal's editors quasi-retracted the paper. It was a confusing move from a research journal that you would expect would have subjected the first paper to rigorous enough peer-review to stand by its publication.
One was written by a chemist at Dow chemical, Thomas Lane. Lane has long been a supporter of silicone implants. He had testified about implants to the FDA, the National Institute of Cancer, and "other similar venues", but he had not been an expert witness, said the journal's disclaimer, writing, "Dow Corning Corporation has not manufactured silicone breast implants since 1992." Lane might be an unbiased scientist, as the journal says, yet he has long claimed that silicone implants are "harmless", which is quite controversial given the science research. Dow Corning might not currently manufacture implants, but that's irrelevant.
The corporation it is compelled to mount an active defense that 'the implants are and always were safe'. Michael Brooks, the other expert in the 'field' who wrote in to provide criticism of the paper was a 'neutral commenter' - according to Analytical Chemistry. However his background is not 'neutral'.
" ...he provided information on the chemical nature of the platinum in silicone breast implants at the FDA panel hearing on breast implants April 2005 on behalf of Inamed Corporation. He was also a member of Health Canada regulatory advisory panels considering applications by Mentor Corporation and Inamed Corporation for new breast implant models in March and September 2005."(Analytical Chemistry 78 (15), 5609 -5611, 2006.)
Brooks and Lane leveled specific criticism at the chromatography methods the authors used, as well as the authors' interpretation of their statistics. The original report's conclusion that "Pt levels [in the experimental group] exceed that of the control group" was spurious, Brooks and Lane said. According to them, the statistics in the paper proved there was no difference in platinum levels between the control and the implanted groups.
Disinterested Parties?
Clearly Brooks and Lane represent the interests of silicone implant manufacturers. But what are Lykissa's interests? Once a doctor at Baylor University, he now owns a toxicology lab and has been trying to show the presence of platinum for years. In 2000, the Minnesota Star Tribune reported that Lykissa had identified reactive platinum in implants that had been removed from women. (The FDA discarded that research for the same reasons.) His latest research was sponsored by a non-profit group dedicated to fighting the use of silicone implants. We can only speculate how he might benefit from the research.
A couple of weeks ago, when editors for Analytical Chemistry published a warning that Lykissa's and Maharaj's evidence flunked "this journal's standards", we wondered about the truth. The editors of Analytical Chemistry chose to throw a lot of doubt on the publication but do we really know why? The journal didn't accommodate a rebuttal from the original authors when they published Lane's and Brook's critiques. Should we trust that the science was lousy? Or should we wonder whether the journal was swayed by the critics' affiliations with Dow Corning Corporation, Mentor Corporation and Inamed Corporation?
So when Analytical Chemistry retracted the paper, did that soothe readers and potential patients, or, as it should have, did it alarm them.
The FDA is still wobbly on the implant safety issue, but we can see which way their leaning. A couple of years ago, in "FDA Breast Implant Consumer Handbook - 2004 (Specific Issues To Consider), the agency provided ample warnings about the implants. Among them, the FDA said that implants could interfere with cancer detection via mammograms, and that mammograms might cause implants to rupture. Women "may not be able to breastfeed" their babies, and there were safety risks to unborn children and nursing infants. There was a "...slight increase in deaths due to suicide", the FDA said, and there was a risk of "Gel bleed". The 2004 report also stated that although "platinum leaches (leaks) from these implants and is present in the surrounding tissue" causing "concern" there was no evidence that "leached platinum causes illness in women with breast implants." Today, two years later, the FDA is hardly more confident about the platinum risks and they continue to call for more research:
"Some studies have shown that small quantities of platinum may bleed through an intact implant shell and be present in trace amounts (parts per billion) in surrounding tissue. However, these results need to be confirmed using a larger number of subjects...Even if the analytical results of large, well controlled studies were to show relatively high levels of platinum in biological samples, the toxicological significance would still need to be determined."
For now, the FDA cites Brooks, the consultant for the silicone implant manufacturer, who votes: "The experimental evidence supports the conclusion that there are no clinical consequences of the platinum in silicone breast implants". The FDA concludes:"[The]FDA concurs with Brook's conclusions.".
So while it seems that neither the FDA nor the journal can really judge the veracity of competing conclusions in the available research, both the journal and the FDA nevertheless appear to favor the opinions of scientists with vested interest in promoting implants. The FDA has repeatedly discounted Lykissa's work. Yet he is not the only scientist with these concerns. Where are the "neutral" scientists? After a quarter of a century, women are still confronted with a sea of confusing, biased data in the leaky boat that is science research on silicone implants.
On a final, slightly different note, breast implant advocates might have more evidence for for their arsenal of reasons for why women should trust the implants. MSNBC reports in "The Breast Job That Saved a Life", that a women hit with shrapnel from an exploding rocket was spared piercing of her heart by her silicone breast implants.
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Acronym Required previously reported on silicone breast implants in Silicone Implants -- A Health Risk to Choose?, and Silicone Implants and the FDA (more).
