Breast Implant Safety – What to Believe?

Dr. Wiener presenting information at the annual meeting of the Texas Society of Plastic Surgeons in San Antonio this past weekend September, 2018.

There is an article that will be published in the next few days in the Annals of Surgery regarding the safety of breast implants, and there are significant questions regarding the data that was used. The first thing to understand about breast implants is that they are the most studied medical device in the history of medicine, and this is because of the breast implant litigation of many years ago.

When publishing an article in the medical literature, there are a number of things that have to happen. I know, as I’ve published a number of landmark articles in the literature that are highly cited. Review of the potential article is done by reviewers chosen by the editor of the publication. In addition to that, the authors of the article have a responsibility to the truth and disclosure of any bias. An example of this is the article that was published in Great Britain, which purportedly showed a link between autism and vaccines. The article and the author’s data was quickly shown to be false, and the journal went to the rare step of removing the article from the publication, not before, however, the discredited and untruthful article setting off a firestorm of anti-vaccine hysteria, all to the risk of safety to children and the public at large.

After the breast implant scare many years ago when a group of questionable entities accused breast implants of causing diseased such as arthritis, connective tissue diseases, etc, the FDA made a harsh decision to remove silicone gel implants from the market. The industry and plastic surgeons (and other specialites including rheumatology) then began the study of breast implants on a huge scale. The accusations made were shown, by valid science, to be completely untrue. The motivation of the accusers became more clear as lawyers used junk science, and scared women into the risks of having unnecessary surgery.

Silicone gel breast implants came back on the market in 2006. Ongoing studies are still required, and this data has consistently shown the safety of silicone gel breast implants. I state this as a board certified plastic surgeon, not because of the income I make when doing breast augmentation, but as a scientist, and a surgeon who has a primary goal of patient safety. If breast implants went away tomorrow, I would still have a good income. Removing an important and safe choice for women was wrong, even before 2006.

In the current article to be published, the authors have used data that was poorly put together, with length of follow up that was insufficient, and some of the data was patient self-reporting, rather than an actual diagnosis by a physician. In using data such as this that is not scientifically valid, it creates the appearance of important information, only because it was published in a respected journal. This calls into question the review process of the journal, and having done reviews for some of the the plastic surgery journals for articles that were submitted for publication, the review process is fairly involved. One obvious issue is that the article was published in Annals of Surgery, a publication mainly for general surgeons, and not published in one of the plastic surgery journals. If the reviewers for Annals were not plastic surgeons, they were likely not aware of the nuances of the plastic surgery literature, and this may be a reason it is being published here in the first place and the article may not have been reviewed by those who are familiar with the issues.

I call into question the data, the journal, and the physicians involved. The authors, who are on staff at MD Anderson Cancer Center, are well respected plastic surgeons, and colleagues of mine who I personally know. I have not spoken to them about this (yet!) but this article does not come anywhere near the quality and validity of articles they have previously published. The FDA has published a rare condemnation of this article. I have never seen them do this in my many years of plastic surgery.

I was at the annual meeting of the Texas Society of Plastic Surgeons this past weekend, and as can be imagined, this was a major topic of discussion, mostly because of how bad the data that was used is.

The moral to the story, if you have breast implants or are considering implants, is to understand the importance of my involvement with the major plastic surgery societies, my training and experience with breast augmentation, and my number one goal- your safety. This paper should be discredited and removed from publication.




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