To quote Rod J. Rohrich, M.D., co-editor of The Plastic Surgery Journal…….
“Nothing reminds me more of my duties as a surgeon than the words of Cicero: Salus populi suprema lex (literally, the safety of the people is the supreme law). The rough American proverbial equivalent that children across America hear every day is, of course, safety first. It’s a simple principle that guides my every action when teaching my students and treating my patients. Unfortunately, it’s a simple principle with a lot of gray areas. Safety can easily transform into paranoia, fear, and lost opportunities if we forget to balance our lives and ethos with well-thought-out risk, chance, and advancement.
With that in mind, the words of nineteenth century American theologian and editor Tryon Edwards ring inherently true in the sphere of science and medicine: Where duty is plain, delay is both foolish and hazardous; where it is not, delay may be both wisdom and safety. In early 1992, amid rising concerns, near-frenzied controversy, and legal actions against manufacturers, the U.S. Food and Drug Administration issued a voluntary moratorium on the use of silicone gel-filled implants for cosmetic breast augmentation.
With nearly 30 years of clinical experience proving implant safety, many thought that duty was plain and that the moratorium on silicone gel implants may have been overly cautious. On the other hand, it was true that the manufacturers did not, at that time, have adequate data to fully address some of the complex issues that had been raised.1 In this instance, despite the controversy and media hype, the duty was not plain and the issue was not clear-cut. The Food and Drug Administration’s decision to delay the manufacturing and use of silicone-filled implants was both wise and safe. The predominant notion at the core of the moratorium was patient safety, which should always come first.
Many of our patients had honest concerns that their silicone implants had caused major health problems, such as lupus and rheumatoid arthritis. Our patients were afraid for their health, and it was our and the Food and Drug Administration’s sworn duty to verify their safety. For the next 14 years, breast augmentation still proved to be a widely desired procedure, and saline implants filled the void left by silicone’s absence. Meanwhile, the Food and Drug Administration and several other independent organizations conducted experiments to prove that silicone gel implants did not cause systemic issues. After more than a decade of research and conversation, including the 1999 report by the Institute of Medicine and the 2005 Food and Drug Administration advisory panel hearing, during which the panel heard more than 20 hours of data presentations and public comment, the Food and Drug Administration made a decision.
On November 17, 2006, the Food and Drug Administration approved Allergan and Mentor’s silicone breast implants and placed the devices back on the U.S. market. Breast augmentation is a surgical procedure and, as with all operations, there are risks involved. Although silicone and saline breast implants both have the risk of localized problems, including capsular contracture, the Food and Drug Administration’s decision, in conjunction with research and reports from the last decade, showed that silicone gel-filled implants do not pose additional risk to women’s short-term or long-term health. The moratorium was the practice of due diligence, and our patients’ safety has been proven to the medical community, the government, and, most importantly, the patients themselves.
Reactions have been positive. Breast augmentation was the number one cosmetic surgical procedure in 2006, with more than 329,000 operations performed. This marked a 55 percent increase in the number of breast augmentations performed from 2000 to 2006 and the first time that the procedure was ranked as the most popular since the 1992 moratorium. In late May of 2007, a press release stated that over half of [American Society of Plastic Surgeons] member surgeons predict they will perform up to 25 percent more breast augmentations in the next 12 months and that 40 percent or more of all patients will choose SILICONE BREAST IMPLANTS. It is truly fantastic that women again have a choice in their breast augmentations, with two very safe and effective options at the core.
Our duty to our patients, however, is never complete. When considering the aphorism safety first, it’s hard not to take the sentiment one step further and consider these words: Safety first is safety always (quotation attributed to Charles M. Hayes).
While the American Society of Plastic Surgeons reports that four out of five members [say] that their personal concern for the safety of the implants was the least significant barrier preventing their patients from choosing silicone breast implants, 45 percent of members [say] their patients’ concerns about safety might be a significant barrier. It is for this reason that we will continue to work and investigate the safety of these implants, and that the Food and Drug Administration is requiring postapproval studies from both Mentor and Allergan; these postapproval studies include a continuation of the core study through 10 years (which will involve nearly 4000 patients), focus group studies of patient labeling, continued laboratory studies to further classify and investigate device failures, and tracking of each and every implant….”
As so eloquently said by Dr Rohrich, Dr Koo agrees that it is always with the patients’ safety that she is concerned and she will help you make the decision as to what surgery and what breast implant is best suited for you. She also takes a careful family breast cancer history and follows you in time to make sure that you have yearly breast examinations as well as mammograms. She truly feels that breast enhancement with silicone or saline implants is very safe and will do everything to help you maintain your safety with your newly enhanced breasts.
Dr Michele Koo, MD, FACS will help you achieve what nature left out and that is beautiful enhanced breasts with either saline or silicone breast implants. Patients from throughout Missouri, Kansas, and Illinois come to see Dr Koo for breast augmentation and breast lifts with breast implants. Please feel free to call for an appointment for your breast augmentation and breast enhancement 314-984-8331, St Louis, Missouri.
