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Plastic Surgery Societies Applaud FDA Panel Recommendation That Mentor's Silicone Breast Implants Be Approved With Conditions
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Plastic Surgery Societies Applaud FDA Panel Recommendation That Mentor's Silicone Breast Implants Be Approved With Conditions
For Immediate Release: April 13, 2005
GAITHERSBURG, MD – The FDA advisory panel’s 7-2 vote today to recommend to the FDA that Mentor’s silicone breast implants be approved with conditions is applauded by the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS), the two largest plastic surgery membership organizations. This recommendation comes 13 years after the FDA restricted access to the silicone implants because of safety concerns. “We are pleased that the panel based its decision on scientific evidence, not on special interests, emotion or anecdotes,” said James Wells, MD, ASPS past president. “The comments by Josh Levine, Mentor’s CEO, during his summation confirm Mentor’s long-term commitment to safety. This should go a long way to assure the FDA and the public that the panel’s recommendation is prudent and sound.”
ASPS and ASAPS are optimistic that the FDA will follow the panel’s recommendation. “By doing so, Mentor can move forward to reintroduce silicone implants as an option for American women. Organized plastic surgery is enthusiastic about working with the manufacturer to ensure women’s health and safety,” said ASAPS President-Elect Mark Jewell, MD. “Plastic surgeons are committed to helping women make informed choices about their health care based on all the available and accurate information about these devices.”
Both societies are prepared to work with the FDA and Mentor to fulfill the conditions which include physician education, patient education, a registry, and a commitment from the manufacturers for continued data collection. Prior to today’s decision, ASPS and ASAPS have taken a leadership role in physician education, patient informed consent, and development of a registry.
On April 12, the FDA advisory panel issued in a 5-4 vote a “non-approvable” recommendation to Inamed’s application for approval of its silicone breast implants. The panel encouraged Inamed to address its remaining concerns and then request panel re-review of its application for approval. “We are hopeful that a similar favorable recommendation will be issued in the near future to Inamed if it can satisfy the FDA’s remaining concerns,” said Dr. Jewell.
To that end, the two societies believe continued data collection and study of the procedure and device are essential, and they are committed to being active participants in post-market monitoring of the implants.
In addition, ASPS and ASAPS will continue to offer assistance to the manufacturers with additional conditions set forth by the FDA related to physician and patient education. At the forefront of their ongoing education campaign is the recently launched joint Web site www.breastimplantsafety.org. This will be the authoritative Web site for both saline and silicone breast implants and offer objective and science-based information.
An increasing number of women are choosing breast augmentation to enhance their appearance. According to ASAPS, nearly 335,000 women chose breast augmentation in 2004. More than 62,000 women had breast reconstruction in 2004, according to ASPS. Breast reconstruction has been proven in numerous studies to have many psychological and physical benefits for women who have undergone a mastectomy.
The American Society of Plastic Surgeons (ASPS) is the largest organization of board-certified plastic surgeons in the world. With more than 5,000 members, the society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. ASPS comprises 94 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the society represents physicians certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada. www.plasticsurgery.org.
The American Society for Aesthetic Plastic Surgery (ASAPS) is the leading organization of board-certified plastic surgeons specializing in cosmetic plastic surgery. Since 1967, ASAPS has been the authoritative source in cosmetic surgery education and research. ASAPS’ 2,200 plastic surgeons are elected to membership and are certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada. www.surgery.org.
Breast Implant Update January 3, 2000
New York, NY (December 19, 2003) — Breast augmentation, also called augmentation mammaplasty, involves surgical placement of an implant behind each breast to increase its volume and enhance its shape. Breast augmentation has been available in the United States for over 40 years. Here is the latest information on breast augmentation which, according to statistics from the American Society for Aesthetic Plastic Surgery (ASAPS), is the second most popular surgical aesthetic procedure (249,641 in 2002).
Recent News About Breast Implants
On October 15, 2003 a Food and Drug Administration (FDA) advisory panel recommended conditional approval of silicone gel-filled breast implants. The results to two surveys of over 5,000 women who either had, or were considering, breast implants (13% of which were silicone gel), have been accepted for publication in Aesthetic Surgery Journal, ASAPS' peer-reviewed clinical journal; the surveys addressed specific concerns previously raised by the FDA regarding patient satisfaction, reoperation, and informed consent. Leroy Young, MD, co-chair of ASAPS' Breast Surgery Committee, presented preliminary findings of the surveys at the October FDA hearings. Key findings include:
89% of women surveyed said that breast augmentation met their goals
Overwhelmingly, women surveyed (94%) said they would recommend the procedure to others.
Only 13% of women reported that they had reoperations; of these, 92% chose implant replacement, not permanent removal.
Of the 13% who had revisional surgery, 35% wanted larger implants, and 27% wanted to improve breast shape or position.
To access the Breast Implants Patients Surveys 2003: http://www.surgery.org/download/implantsurvey.pdf
Silicone-Gel Survey
Following the advisory panel decision, the American Society for Aesthetic Plastic Surgery sent a survey to 100 of the leading aesthetic plastic surgeons in the United States, and asked them whether they believed the availability of silicone gel-filled breast implants would significantly increase the demand for breast augmentation; more than half (54 percent) of survey respondents said it would not have a significant impact. However, 88 percent of respondents said that being able to choose silicone gel implants would increase breast augmentation patient satisfaction with the results of surgery.
The Beauty of Breast Augmentation
During breast augmentation, implants are inserted through an incision - usually made just above the breast crease, around the pigmented skin surrounding the nipple, or in the armpit - and placed into a "pocket" created by the surgeon behind the breast tissue or the chest muscle. Breast augmentation is requested to add volume to small or underdeveloped breasts, or to restore volume lost as a result of weight loss, childbirth, or aging.
Breast augmentation can be performed at any age after the breasts are fully developed, but there are regulatory restrictions on the use of breast implants in women younger than 18. There is no scientific evidence that breast augmentation increases the risk of breast cancer, autoimmune disease or any systemic illness, nor is there evidence that breast implants affect pregnancy or the ability to breast feed. In addition to the positive aesthetic outcomes of breast augmentation, data have shown that many patients enjoy substantial psychological benefits, including enhanced self-esteem.
Breast Implants Through the Years
Prior to 1963, and sometimes in the hands of non-medical practitioners, experimental methods of breast enlargement included paraffin injections, silicone injections and the insertion of sponges. None of these methods achieved satisfactory long-term results, and injections to the breast proved to be extremely dangerous. Then, in 1963, the first silicone gel-filled breast implants were introduced, followed by the introduction of saline-filled implants in 1965.
Beginning in the 1970s, several manufacturing companies began mass-producing breast implants. Options were enhanced with the introduction, in 1974, of inflatable implants. In 1976, double lumen implants appeared on the market; these implants had an interior chamber filled with silicone gel and an outer, saline-filled chamber. In the late 1980s, textured-surface implants were introduced on the theory that the textured shell would modify the process of scar formation and reduce the incidence of capsular contracture (breast firmness caused by scar tissue contracting around the implant, still the most common problem associated with breast augmentation); ongoing studies on the effectiveness of textured-surfaced implants in reducing contracture have shown mixed results. Throughout the '70s and '80s, plastic surgeons, and especially members of the American Society for Aesthetic Plastic Surgery, gained significant clinical experience with breast implants and found that women generally were pleased with the results.
The Breast Implant Controversy of the '90s
In the early 1990s, breast implants became the subject of heated controversy as reports of women claiming their implants had seriously damaged their health became widely publicized in the media. In 1991, implant manufacturer Dow Corning lost a multi-million dollar lawsuit based on claims that its implants were the cause of a plaintiff's autoimmune disease. In January 1992, the FDA issued a voluntary breast implant moratorium and, in April, the agency issued a ban on the use of silicone-gel filled implants for cosmetic augmentation. Women seeking breast reconstruction were still permitted access to gel implants, and some other exceptions applied. There was some concern that the FDA's actions were not based on science but, rather, on political and social pressure; nevertheless, even proponents of implants acknowledged that scientific data were lacking or incomplete to refute the claims that implants might be associated with autoimmune and other systemic illnesses.
Plastic surgeons found themselves in the middle of this controversy. Nearly 30 years of clinical experience led them to believe that implants were safe, and they sought to reassure anxious patients. Nevertheless, they recognized that manufacturers did not have adequate data to fully address some of the complex issues that had been raised.
While the controversy raged, saline-filled breast implants continued to be generally available for both breast reconstruction and augmentation.
In 1994, so-called "anatomical implants," aimed at creating a more naturally sloped breast contour, were introduced on the market. Whether such implants actually produce a more natural breast shape is still controversial.
Saline Implants Win FDA Approval
A turning point in the breast implant controversy occurred with the June 1999 release of a comprehensive report on breast implants by the National Academy of Science's Institute of Medicine (IOM). By this time, there had been a number of major studies failing to find an association between implants and autoimmune diseases or cancer. The scientists who prepared the IOM report reviewed all the available studies and concluded that there was no solid scientific evidence to connect breast implants and any disease. Similar findings were published by health agencies in the United Kingdom and by the European Committee on Quality Assurance and Medical Devices in Plastic Surgery (EQUAM).
In May 2000, the FDA gave its official approval to saline-filled breast implants, finding them both safe and effective for breast augmentation and reconstruction. Saline-filled implants provide excellent results for most women, and the popularity of breast augmentation surgery appears to be ever increasing. Still, the search for the "perfect" implant - one that creates a naturally shaped, natural-feeling breast and avoids the problems of capsular contracture - continues. One implant-filler alternative that appeared promising was the soybean oil-filled implant but, in 2000, questions of long-term safety and effectiveness led to its discontinuation by the manufacturer.
A handful of physicians from various specialties have promoted breast enlargement by fat injection as a safe and effective alternative to implants. The American Society for Aesthetic Plastic Surgery issued a position statement flagging the potential dangers of this procedure. This method of breast enlargement may produce only temporary results due to absorption of the injected fat; a more serious consequence is fat calcification and its impact on mammography and early detection of breast cancer.
Suicide and Breast Augmentation
Analysis shows that actual suicide rates may be lower than expected among women who undergo breast augmentation, and that the procedure may actually confer protection from suicide, according to Thomas Joiner, PhD, Professor of Psychology at Florida State University and a leading expert on suicide. Dr. Joiner's research was published in the September/October (2003) issue of Aesthetic Surgery Journal, ASAPS' peer-reviewed clinical publication. To access ASAPS' news release on Dr. Joiner's findings, click on the following link: http://www.surgery.org/press/news-breast-33.asp
Breast Implants: Now
Currently, almost all women in the U.S. undergoing breast augmentation receive saline-filled implants. Approximately 10% of women undergoing breast procedures receive silicone gel-filled implants, but this is permitted only for breast reconstruction, implant replacement, and severe breast ptosis (sagging). In October 2003, the FDA reviewed new data on silicone gel-filled implants that was derived from ongoing clinical studies and was submitted by implant manufacturers with the hope of winning FDA approval for reintroduction of silicone gel-filled breast implants for general use in breast reconstruction and augmentation. The FDA's advisory panel recommended reintroduction of silicone gel implants for general use with conditions. The FDA usually follows the recommendations of its advisory panels, but has not yet ruled on the safety and efficacy of silicone gel.
Silicone gel remains a potentially popular implant choice primarily because it produces a natural-feeling breast and is particularly effective for women with minimal breast tissue. Recently, a new formulation of silicone gel, which is thicker than previous gels and retains its shape even in the event of a tear or rupture of the implant shell, has been developed and is undergoing clinical trials. Called "cohesive silicone gel," this new filler innovation has already been used extensively outside the United States, and eventual FDA approval is anticipated.
The use of sustained mechanical force to induce tissue growth in the breasts has been touted as a method to achieve modest enlargement of the breasts. While some physicians have reported promising results with this technique, others claim widespread failure to achieve satisfactory results with consequent patient disappointment.
What Does the Future Hold?
Some researchers say that new tissue engineering technology using stem cells derived from liposuctioned fat may someday be used to "grow" breast tissue. Or breast enlargement may be achieved through manipulation of hormones or other chemical or biological substances.
These and other innovations are likely to provide increased options for breast augmentation in the 21st Century. In the meantime, women seeking breast enlargement have a variety of choices, and most breast augmentation patients will achieve a high level of satisfaction with the current methods and devices. Surveys consistently show that the overwhelming majority of women who undergo breast augmentation say they would make the same decision again.
Courtesey of American Society for Aesthetic Plastic Surgery (ASAPS
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