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FDA Warns Against Use of Injectable Silicone for Breast Enhancement

FDA Warns Against Use of Injectable Silicone for Breast Enhancement

Author: Mr. Olivier Branford MA(Cantab), MBBS(Lon), PhD(Lon), MRCS(Eng), FRCS(Plast)

In the last year breast augmentation using fat grafting (where fat obtained by liposuction is injected back into the patient's breasts) increased 72 percent, whereas breast augmentation using implants increased by 4 percent. There are many well designed studies in large populations of women over many years documenting the safety of these techniques. Recently these techniques have been combined, giving a natural enhancement.

"Nonsurgical" breast enhancement has continued to attract mainstream press attention, with two previous treatments generating concern from board-certified plastic surgeons: "InstaBreast lunchtime lift" using saline injections which last only hours and "Botox breast lift." Literature searches have revealed no studies supporting the safety or effectiveness of either treatment.

There have been numerous reports of many off-label items being injected into the breast - everything from raw silicone and synthetic oils to tyre sealant and even cement! Not only are these items not safe, but they can be potentially deadly.

More worryingly there has been a resurgence of silicone injections as an alternative to breast augmentation. This is a criminal activity that is being touted by untrained cosmetic doctors or practitioners that is likely to result in severe harm. Having raw silicone injected into your breasts will ultimately make your body build scar tissue around the silicone, causing pain with inevitable hardening of the breasts, with catastrophic irreversible damage to the tissues over time.

The U.S. Food and Drug Administration (FDA) has just made a press release stating that it has NOT approved injectable silicone (silicone oil) for large-scale body contouring or enhancement including the breast and buttocks. Such use can lead to ongoing pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism (blockage of a blood vessel), stroke, and death. The FDA is aware of cases where patients have received injectable silicone for body contouring purposes, such as gluteal or breast enhancement ("buttock fillers" or "breast fillers"), by unqualified providers posing as doctors or licensed healthcare practitioners in non-clinical settings such as residential homes or hotels. The FDA is aware that some injectors have falsely told consumers they were receiving an FDA-approved dermal filler, but consumers were instead injected with silicone.

Injectable silicone is permanent, with side effects that can occur right after the injection and up to years after treatment. Silicone spreads and migrates easily inside the body, which may worsen adverse events and make surgical attempts to remove the silicone oil more difficult or impossible. Silicone, when injected into areas with many blood vessels such as the buttocks, can travel to other parts of the body and block blood vessels in the lungs, heart, or brain. This can result in permanent damage to those tissues and lead to stroke or death. Costly and repeated surgery to remove large-scale injectable silicone may present additional risks and serious complications, and may not entirely rid the body of the silicone. Multiple medical and surgical interventions are sometimes needed to treat symptoms years after initial injection; even then, patients may continue to experience ongoing pain, infection, and scarring and permanent disfigurement requiring ongoing treatment.

If you are considering a body enhancement or body contouring procedure, only see a licensed health care provider who has appropriate training and experience (e.g., a plastic surgeon). The FDA has investigated numerous criminal cases related to injectable silicone, which have resulted in successful prosecutions.

Patients are advised to check what most fully trained plastic surgeons are doing: a good indicator of treatment safety and efficacy. According to the Royal College of Surgeons of England, new proposals would ensure that cosmetic surgery is performed only by specialist surgeons to "stop all the cowboy behavior which goes on." Regulation must focus on evidence - the foundation of patient safety.

Advocating unproven treatments is immoral: medically ethical behavior rests on patient trust, beneficence, nonmaleficence (doing no harm), and justice. So why do some doctors perform procedures with no evidential support? The answer must surely be simple - profit. To be a great plastic surgeon, one must have great integrity: it is our responsibility to practice evidence-based medicine, and decry those that fly in the face of it.

The bottom line is that fillers in the breast simply do not work, may be very dangerous, and administering free silicone is a criminal act. Conversely, fat transfer and breast implants have a proven safety record. It is always so important to do your homework on who is a fully trained plastic surgeon. Do not get injectable silicone or any type of filler material for large-scale body contouring or breast enhancement. If it sounds too good to be true it usually is!