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Liquid Silicone Injections: Patients Should Think Twice
Liquid silicone injections used for the augmentation of soft tissues remains a hotly debated and very controversial topic. Although silicone breast implants were approved by the FDA in 2006 and the newest form stable silicone breast implants are in clinical trials, the use of injectable liquid silicone is a very different and real concern. Liquid Silicone as injectable filler: the problem Once injected liquid silicone is permanent and it cannot be altered or removed. Many reports of complications have been published, including severe complications from liquid silicone used for breast enlargement as long ago as the 1950s. I have performed several breast reconstructions on women who had liquid silicone injected into their breasts for augmentation in the 1960’s, who developed disastrous complications and required total mastectomies decades later. Almost all of the problems noted were never seen by the injecting physician as they tend to arise years after injection. Among
Enhanced Patient Education with the Vectra Breast Simulator
A tremendous effort has been placed on redefining breast augmentation as more than just a surgical procedure. The Plastic Surgery journals are full of peer-reviewed publications that clearly document improved long term outcomes when there is effective communication between the physician and the patient. The decisions made by both the surgeon and patient during the pre-operative consultations may have more of an impact on the quality of the outcome and its longevity than the implant selected or the augmentation procedure itself. It is during this educational process that surgeons have the best opportunity to simultaneously introduce the informed consent documents that let the patient know that they are involved, and responsible for their decisions. An effective educational process must link understanding with accountability and what really matters is whether the patients understand, acknowledge, and take responsibility for their decisions. In the medical setting, the term “informed consent” arose in the
The Long Road Back for Silicone Breast Implants
I have recently added a new page to my web site entitled “The Safety of Silicone Breast Implants – The Science Behind the Politics”. The journey to assure women access to safe and effective silicone breast implants has been a long and complicated one, fueled by emotions and politics on both sides of the conflict. This month, Sientra, a company that manufactures breast implants in Brazil, received an approvable letter from the FDA for their round and shaped silicone gel implants. This means that a third manufacturer will enter the US implant market after almost twenty years. It appears likely, as well, that American women will also finally see the FDA grant approvals to the two other leading international manufacturers of form stable implants; Allergan’s style 410, and Mentor’s CPG, both 5th generation shaped silicone gel implants. The availability of modern, safe, silicone gel implants has not come without a
The French PIP Silicone Breast Implant
Last year, the French based company PIP (Poly Implant Prothèse) had their implants banned because it was discovered that they were utilizing a non-medical grade silicone as the filler for their gel implants. In addition, the recent reported death of a French woman from the rare form of cancer ALCL, who had PIP breast implants has led to a tremendous amount of media concern about a company recognized by few American women. Inspections in France as early as 2001 had revealed numerous non-conformities surrounding the manufacture of PIP implants. In 2009, it was reported that there were high rupture rates with their implants in France, leading to allegations of implant shell problems. In 2010 distribution was suspended and the company filed for bankruptcy. PIP appears to have used two types of silicone gel within their breast implants; the “Medical Grade” silicone manufactured by Nusil, (made in US and France), and
Separate the Facts from Fiction on the Rare Association between ALCL and Breast Implants
The FDA issued a press release today concerning an uncommon form of lymphoma (ALCL) that has been reported to occur extremely rarely in women with breast implants. Epidemiologists have been following these reports since 1989 and the FDA press release today issued a summary of these investigations for both patients with breast implants and their physicians: There is no evidence of any relationship between breast implants and breast cancer. Of the estimated 10,000,000 women worldwide with breast implants, there have been only 34 cases of ALCL ever reported. The known risk of a woman with a breast implants developing ALCL is approximately 1:1,000,000 women. (One in a million chance). By comparison, a woman’s lifetime risk of developing breast cancer is 1:8. These numbers may help you to understand how extremely rare this form of Lymphoma actually is. This uncommon form of Lymphoma has been associated with both saline and silicone
Awake Breast Augmentation – What they’re not telling you
The media is once again spinning with stories about “Awake Breast Augmentation”. For better or worse, some surgeons in my opinion, are using the media and internet to increase their market share by pushing the limits on safety, while losing site of the long term results of breast augmentation. There are at least two very important concerns with regard to “Awake Breast Augmentation.” The first issue is patient safety. The advertised procedures certainly sound like a bargain. One patient was quoted to have saved almost $3000. The savings most likely come from the nonattendance of a board certified Anesthesiologist, or procedures that are not performed in an accredited surgical facility. Breast augmentation is a surgical procedure. There are risks associated with bleeding, infection, and damage to surrounding structures. In addition, this procedure adds the risk of overdosage of local anesthetics, a very real potential risk if the surgery is performed
Don’t be Mislead by Cohesion Confusion
The more cohesive silicone gel is, the thicker and firmer it becomes. Silicone gel comes in a range of firmness, and the highly cohesive breast implants are believed to be just firm enough to resist forming creases and folds, yet soft enough to feel like a natural breast. Unfortunately, many surgeons are using the term cohesive to describe the “regular” round FDA approved silicone gel implants. To be precise, they are correct; all silicone gel is cohesive to some degree. But the term cohesive has always meant form stability, and when patients ask for cohesive gel, it is because they want an implant that possesses resilience and shape retention. The form stable highly cohesive gels, “Gummy Bears” that are presently available in the United States are always shaped devices, they are presently not available in the United States in a round “version”. The intended advantage to a shaped device is