| ASAPS and ASPS
Joint Position Statement
Saline-Filled Breast Implants
July 9, 2002
Introduction
 The American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS) offered testimony on saline-filled breast implants at the U.S. Food and Drug Administration's (FDA's) public advisory committee meeting of the General and Plastic Surgery Devices Panel July 9, in Gaithersburg, MD.
ASAPS and ASPS believe that the weight of current scientific evidence supports the FDA's approval and continued oversight of these devices. Both organizations support a woman's right to choose implants for breast reconstruction or enlargement as well as her right to be fully informed of both the risks and benefits of implant surgery.
History
The FDA's General and Plastic Surgery Devices Panel is continuing an ongoing regulatory process of saline-filled breast implants, a process that began in 1988.
The two manufacturers of approved saline-filled breast implants, also called saline inflatable breast implant devices, are presenting an update on postmarket information to the committee as previously requested.
Saline-filled breast implants have been available since the late 1960s. Like most medical devices, they have evolved in both design and production.
The FDA Medical Device Amendments were enacted in 1976 by Congress, giving the FDA the authority to regulate medical devices such as breast implants, which were already on the market. In 1988 the FDA classified all breast implants as class III medical devices requiring strict controls for safety and effectiveness.
In May 2000 the FDA approved, with conditions, premarket approval applications (PMAs) for saline-filled breast implants manufactured by Mentor Corporation and McGhan Medical (now Inamed Aesthetics).
Issues that have been raised related to the safety of saline-filled breast implants have been addressed through scientific studies. Implants today are more reliable than implants manufactured in earlier years, though no implant is guaranteed to last a lifetime. Breast implants are like other implants (for the knee, hip, etc.), which represent a foreign element in the body. There is an expected reoperation rate.
Scientific Data -
In May 2000, the FDA gave its official approval to two manufacturers of saline-filled breast implants, finding their implants both safe and effective for breast augmentation and reconstruction.
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Saline-filled implants provide excellent results for most women, and the popularity of breast augmentation surgery appears to be ever increasing, with over a million women choosing breast augmentation in the last decade.
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Ongoing research continues to document positive outcomes in relation to saline-filled breast implants. For example, all information indicates that women with implants are able to breast feed with the same degree of comfort and/or difficulty experienced by women without implants.
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Published studies in peer-reviewed medical journals have found no persuasive evidence of a causal association between breast implants and any type of cancer.
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Studies have documented the high patient satisfaction rate, with the vast majority of breast implant patients saying they would make the same choice again.
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A multi-site prospective outcome study on patient satisfaction following aesthetic surgery is underway. This study will provide additional data on this critical subject.
Saline Implants: Potential Risks
Besides deflation, the major risks associated with saline-filled breast implants are local complications such as altered sensation, breast pain, wrinkling, asymmetry, and capsular contracture. Capsular contracture is the tightening of natural scar tissue around the implant, which can cause breast firmness. The occurrence of capsular contracture is unpredictable and, sometimes, severe. Several of these local complications may result in the need for reoperation.
A theoretical concern associated with breast implants is the possibility that the devices may interfere with the early detection of breast cancer through mammography. Mammography of the augmented breast requires special techniques and additional x-ray views. However, a study published by the University of Southern California of breast cancer diagnosis and survival among 3,182 women with breast implants in Los Angeles County, showed the stage of cancer diagnosis was virtually identical to that of all breast cancer patients in LA County. Moreover, the five-year survival rate was consistent with rates established by the National Cancer Institute. Additionally, there is no evidence that implants cause breast cancer. In fact, two major studies have shown a lower than expected rate in women with breast implants.
Informed Consent
ASAPS and ASPS believe that informed consent is crucial to successful breast implant surgery. Informed consent results when patients are provided with all the facts and information necessary to make an educated decision to proceed with a medical treatment or surgical procedure. Full informed consent is in the best interests of both patients and physicians.
Conclusion
ASAPS and ASPS support the FDA in its effort to ensure patients receive safe and effective medical devices. Patient safety is the primary concern of all plastic surgeons. Scientific studies on the safety of breast implants support the more than 30-year clinical experience that saline-filled breast implants are safe medical devices. ASPS and ASAPS support additional research on saline-filled breast implants.
Women who choose breast implant surgery are often made to feel that the procedure is unnecessary and poses undue risk. Yet studies confirm that the vast majority of women who choose breast augmentation experience improvements in body image, self-esteem and quality of life.
Women must have the right to choose implant surgery with full informed consent, which means complete and up-to-date information regarding potential risks and benefits. Additionally, women who have undergone breast augmentation by board-certified plastic surgeons report that they are being adequately informed about the risks and benefits of breast implant surgery and that their surgeons are responding to their questions and needs.
The American Society for Aesthetic Plastic Surgery (ASAPS) is the leading organization of board-certified plastic surgeons who specialize in cosmetic surgery of the face and body. The American Society of Plastic Surgeons (ASPS) is the largest organization of board-certified plastic surgeons in the world. Members of both organizations are certified by the American Board of Plastic Surgery.Click here to read more articles about breast enlargement
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