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Archive for June, 2013

Breast Augmentation and Safety with Silicone Breast Implants

Wednesday, June 12th, 2013

It is news because the FDA asked for a voluntary moratorium on breast implants beginning in 1992. The companies that manufacture the implants and the plastic surgery community complied. The FDA lifted the moratorium in 2006 making silicone breast implants available again to women. Now you may be asking yourself, “What is it that prompted this moratorium?  If they were considered a risk in the past, why are they so popular now?”

Silicone-gel implants are safe and effective

In the late 1980s, a number of anecdotal reports began appearing in the literature, describing rheumatologic symptoms in some women with implants. Media frenzy quickly ensued, resulting in the imposition of the moratorium on the use of silicone implants by the FDA in 1992. The implants were made available only to clinical investigators. Our practice was involved with some of these studies. There was no scientific evidence to support the anecdotal silicone gel implant claims but, to be fair, at that time there was no scientific evidence specifically disproving the association of silicone gel implants with systemic disease. The moratorium prompted intense, thorough investigative studies by independent institutions by multiple investigators, in various subspecialties including radiology, rheumatology, internal medicine and plastic surgery.

The scientific evidence

In June 1999, the Institute of Medicine of the National Academies of Science published its report, the result of a two-year investigation of more than 2000 peer-reviewed studies and 1200 data sets and reports. The Institute concluded, “There is no definitive evidence linking implants to cancer, immunologic diseases, neurologic problems, or other systemic diseases. Women with breast implants are no more likely than other women to develop these illnesses.” Silicone gel implants were not taken off the market in Europe. In 1999, the European committee on quality assurance and medical devices in plastic surgery issued a consensus declaration based on different studies. The committees concurred that gel implants do not cause cancer, autoimmune disease, connective tissue diseases, any “new silicone diseases,” or systemic illnesses. Meanwhile, the major implant manufacturers in the United States persisted with their thorough investigations and presented data to an FDA advisory panel in 2003, which recommended approval of these devices to the FDA. In 2005 after reviewing even more data from the manufacturers, there was additional FDA approval of silicone gel implants. Dr. McCafferty was involved in a collaborative study regarding the safety and efficacy of breast implants with two other surgeons one from the Midwest and another from the West Coast. The results of the study were presented at the annual meeting of the American Society for Aesthetic Plastic Surgery several years ago, and won the prestigious Tiffany Award for Best Scientific Presentation. The study was later published in the Aesthetic Surgery Journal, the largest peer reviewed journal in the world dedicated solely to cosmetic surgery.

Why Silicone Over Saline?

Now, Dr. McCafferty says, no implantable device on the planet has been more thoroughly studied than silicone gel implants. Two thousand institutions have explored the potential risks of silicone-gel breast implants, across 1,200 different data points, and have proved that these implants are not associated with breast cancer, autoimmune disease or any other systemic diseases.

Now the FDA decrees these implants “safe and effective” and patients are enjoying the benefits. Where water is not compressible, silicone gel is, causing the overall effect to be softer, feel better and more natural in most patients.

Are there any complications with silicone breast implants?

Breast augmentation of any sort is a surgery and, therefore, taken seriously.  However, silicone implants largely have the same risks as saline implants. Complications are uncommon and include hardening, the need for re-operation, implant removal, or deflation.  Today’s silicone implant is more form stable which allows it to retain its integrity even when ruptured, reducing concerns about free silicone in the body.

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