by Mark D. Epstein, M.D., F.A.C.S.
On November 17, 2006, the FDA approved the use of silicone breast implants for breast augmentation and reconstruction. All breast implants have a solid silicone shell. Saline implants are filled with saline (salt water) and silicone implants are filled with silicone gel. Up until recently, only saline implants were available for general use in breast augmentation.
Silicone gel implants were used for many years in this country, as well as in many countries around the world, until 1991 when the FDA enacted a moratorium on their use, pending the results of several studies designed to examine the safety of the device.
Based on the research collected in the US and the practical experience gained outside of the US for the past 25 years in over 60 countries, where both silicone and saline have been available to women and 90% of the markets prefer silicone, women generally find silicone breast implants to look and feel
more natural than saline implants.
The safety of silicone-filled breast implants is supported by extensive pre-clinical device testing, their use in approximately 1,000,000 women worldwide and nearly a decade of U.S. clinical experience involving more than 80,000 women.
Women in the United States now have the same options that women in other countries have had for so many years. As a skilled and dual board certified plastic surgeon I now can provide my patients with the newest option in breast aesthetics that provides women with the most natural look that is proportionate and individualized to their body types and aesthetic goals.
There are several myths about silicone gel breast implants which need to be dispelled.
Myth #1: “In general, silicone products are not safe for use in the body”. Fact: For many years, silicone has been used in numerous medical devices including pacemakers, artificial joints, and even baby pacifiers.
Myth #2: “Silicone implants rupture due to normal activities or mammography. Fact: It is unlikely that silicone implants would rupture following routine physical activity or mammograms. Today’s breast implants have a thicker shell and an additional barrier layer that makes them stronger. They can withstand more than 25 times the force of a normal mammogram without failure. Breast implants, both saline and silicone are not lifetime devices. It is possible that they may fail at some point in a woman’s lifetime and may require replacement.
Myth #3: “Silicone gel implants cause cancer or diseases like rheumatoid arthritis and lupus”. Fact: Silicone breast implants are among the most extensively studies medical devices in history, with thousands of published reports supporting their use. There has been no proven connection between silicone implants and cancer or other diseases.
Myth #4: “Silicone breast implants can adversely affect a mother’s milk and interfere with breast feeding. Fact: Studies found no evidence of elevated silicone in mother’s milk or any other substance harmful to infants. All mothers with silicone breast implants are encouraged to breast feed.
Myth #5: “Breast augmentation surgery often results in unnatural and disproportionate results”. Fact: Through proper pre- surgical planning, assessing not only the dimensions of the woman’s chest, but also her tissue dynamics, breast augmentation usually provides a result that is in line with a woman’s expectation of surgery.
The FDA’s decision confirms that silicone gel-filled breast implants are a safe and effective option for women seeking breast implant surgery. Now, with the FDA approval of Silicone-Filled Breast Implants, I am able to offer a broader range of options to all of my patients, many of whom desire to rejuvenate their breasts after child bearing, or enjoy a fuller shape for which nature has otherwise denied them.
Dr. Mark Epstein is a dual board certified plastic surgeon specializing in breast augmentation, with a special focus on improving the patient experience before and after surgery.
