• Silicone Breast Implants: Scientific update (July 17, 1998)
• National science panel finds no evidence linking silicone breast implants to systemic disease

Silicone Breast Implants:
Scientific update (July 17, 1998)

The July 22-24, 1998 meeting of the Committee on the Safety of Silicone Breast Implants (Institute of Medicine, National Academy of Sciences) in Washington, DC represents an opportunity to review the substantial scientific and clinical data on breast implant safety that has been gathered since the Food and Drug Administration (FDA) placed restrictions on the use of silicone gel-filled breast implants in 1992. The American Society of Plastic and Reconstructive Surgeons (ASPRS) and the American Society for Aesthetic Plastic Surgery (ASAPS) believe that current data substantiates scientifically that women with breast implants are at no large risk for the development of connective-tissue disease (CTD), even in the case of implant rupture, and are at no increased risk for breast cancer or other cancers.

The results of more than 20 important epidemiologic studies of CTD and breast implants have become available since 1992. These studies have been conducted by some of the most prestigious research institutions both nationally and internationally. The overwhelming consensus of researchers from a variety of medical specialties is that there is no scientific proof of an association between breast implants and the development of CTD.

Findings regarding breast implants and cancer have been equally reassuring. Research has substantiated that women with breast implants have no increased risk for developing breast cancer, and a study by the U.S. National Cancer Institute showed a lower cancer risk among implant patients compared to women without implants. There is no scientifically proven explanation for why women with breast implants might have a lower rate of breast cancer.

A study by the Alberta Cancer Board found that diagnosis of breast cancer in women with implants was not delayed. In this study, tumors were detected at an earlier stage among the implant patients compared to women without implants. However, plastic surgeons routinely counsel patients that implants will make mammography more difficult and require extra mammographic views. There is a theoretical possibility that an implant could block the view of a small breast tumor. Scientists are continuing efforts to develop radiolucent breast implant fillers that would allow breast tissue adjacent to an implant to be more easily seen.

From a scientific and clinical perspective, the major area of concern over breast implants is local complications. These primarily are implant rupture and capsular contracture, either of which may cause patients to undergo additional surgery with its attendant risks.

Clinical data on the incidence of implant rupture vary widely; frequency of rupture (More) appears to be greater for certain implant models. However, reports of implant rupture rates are difficult to evaluate; they often are based on examination of women with suspected problems and may not represent the incidence of rupture in the implant population at large. A 1997 Mayo Clinic study of an unbiased patient population showed a rupture rate of 5.7%. Other studies have reported rupture rates of less than 6% and more than 50%, depending on the population sample.

Unlike inflatable saline solution-filled implants, silicone gel-filled implants do not "deflate" and may produce no visible signs of rupture. The gel usually remains confined within the scar capsule surrounding the implant. While this confinement of the gel makes its subsequent surgical removal easier, it makes the diagnosis and scientific study of implant rupture more difficult. A well-designed, large-scale multicenter study is needed to close the gap in knowledge about the incidence of gel implant rupture.

Capsular contracture (unnatural breast firmness caused by tightening of scar tissue around the implant) is the most frequent local complication associated with breast implants. Clinical data on contracture rates also are diverse. A number of studies show that, in the short-term, textured-surface silicone implants may reduce the incidence of capsular contracture, but it is unknown whether this effect is long-lasting. Some data suggest that saline implants are associated with a lower incidence of contracture than silicone gel-filled implants, but the evidence is inconclusive. Patients may be better candidates for a particular type of implant based on a variety of anatomic considerations as well as a prior history of contracture.

The controversy over breast implant safety that dominated media coverage in the early 1990s had both negative and positive consequences. On the negative side, many thousands of women were exposed to misinformation based largely on anecdotal accounts of the alleged risks of implants as reported by the media. Some of this misinformation clearly was perpetuated by powerful special interest groups for monetary gain or media impact. The net result was a wave of panic. In some cases, women largely based their decision to assume the risks of additional surgery for implant replacement or removal on nonscientifically-based information.

On the positive side, the implant controversy encouraged greater attention to large-scale epidemiologic studies that now have provided doctors and patients with scientific facts and significant reassurance about the safety of breast implants.

Patients' increased awareness about the advisability of periodic breast examination by their plastic surgeon has enhanced the overall quality of care and facilitated long-term monitoring of implant patients.

It is the goal of board-certified plastic surgeons to foster scientific investigation of all issues that have been raised about breast implants in order to ensure the safety and well-being of patients; to assist in the accurate diagnosis of breast implant patients who complain of symptoms; to obtain accurate scientific assessment of the durability of breast implants so that patients can be advised about the incidence of implant rupture and appropriate surgical intervention; to attain a scientific understanding of the causes of capsular contracture and to develop more effective treatments; and to enhance overall patient satisfaction with the results of breast augmentation and reconstruction following mastectomy.

More than $3 million in funding for breast implant research has been administered by ASPRS, ASAPS and their respective educational foundations (Plastic Surgery Educational Foundation [PSEF] and Aesthetic Surgery Education and Research Foundation [ASERF]) under guidelines that ensure the independence and scientific integrity of approved research projects.

The American Society of Plastic and Reconstructive Surgeons (ASPRS) represents 97% of all physicians certified by the American Board of Plastic Surgery (ABPS). ABPS surgeons perform both cosmetic and reconstructive plastic surgery. The American Society for Aesthetic Plastic Surgery (ASAPS) is dedicated to the continuing education of board-certified plastic surgeons in the science and art of cosmetic surgery. Together, these organizations educate the public about the benefits and potential risks of cosmetic surgical procedures.

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Breast Cancer and Reconstruction: Exploring the options, procedures and perceptions
Breast cancer. It is the leading cancer diagnosed in women in America. This year, it will affect the lives of more than 180,000 women for the first time -- and end the lives of 40,000 more. Thanks to proactive efforts like National Breast Cancer Awareness Month celebrated in October, the disease doesn't automatically mean a death sentence. However, the impact breast cancer has on the lives of its victims is arguably life altering -- and not easily erased. *In this article, we will share the experiences of five women who have survived the disease, as well as the expertise of several ASPRS members who specialize in breast reconstruction after breast cancer. It is our hope that the information presented in this article will serve as a valuable resource in your journey through breast cancer treatment and recovery.

A Diagnosis of Cancer
Fear. Shock. Denial. These are just a few of the emotions women experience upon learning they have breast cancer. Jayne Siebold, of Hinsdale, Ill., was 49 when she was diagnosed with the disease and explains her initial reaction to the news. "When the doctor confirmed it was cancer, I remember thinking, 'they can't be talking about me, this must be a mistake. Then the fear kicked in."

Barbara Taylor of Dallas went into physical shock. "Everyone I had ever known or heard of who had the disease died from it. So the fear I experienced initially was completely overwhelming, virtually crippling."

When Sue Kocsis of Omaha, Neb., was diagnosed she was 34 years old and the mother of three little girls. "The entire process was extremely overwhelming. It took visits to five different physicians before the cancer was actually diagnosed, so in the beginning I was relieved to know just what I was dealing with -- but felt a tremendous amount of anger toward the doctors who kept telling me it was just fibrocystic disease and nothing to worry about."

The treatment of breast cancer involves a physical change to the body. As a result, it can have a profound psychological impact. "A woman's breasts are deeply rooted in her sense of femininity...her role as mother and nurturer, " says Jack Bruner, MD, of Sacremento, Calif. "Therefore, facing the loss of one or both breasts can be very traumatic." Dr. Bruner recommends that every women diagnosed with breast cancer request information about reconstructive options from their general surgeon and seek the opinions of several plastic surgeons prior to surgery.

Reconstructive Solutions
Almost any woman who loses her breast to cancer can have it rebuilt through reconstructive surgery. And discussion about reconstruction can start immediately after diagnosis. Ideally, you'll want your breast surgeon and your plastic surgeon to work together to develop a strategy that will put you in the best possible condition for reconstruction.

There are several reconstructive options available after mastectomy. Typically, your plastic surgeon will make a recommendation based upon your age, health, anatomy, tissues and goals. The most common procedures include skin expansion followed by the use of implants, or flap reconstruction.

Flap reconstruction is a more complex procedure than skin expansion. Scars will be left at both the tissue donor site and at the reconstructed site, and recovery time is longer than with an implant. However, when the breast is reconstructed with one's own tissue, the results are generally more natural and concerns related to implants are non-existent. Recovery times for both procedures range from six months to one year, or longer, depending on individual circumstances.

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Skin expansion
This common technique combines skin expansion and subsequent insertion of an implant. Following mastectomy, your plastic surgeon will insert a balloon expander beneath the skin and chest muscle. Through a tiny valve mechanism buried beneath the skin, he or she will periodically inject a salt-water solution to gradually fill the expander over several weeks or months. After the skin over the breast area has been sufficiently stretched, the expander is removed in a second operation and a more permanent implant -- either saline or silicone -- will be inserted. Some expanders are designed to be left in place as the final implant. The nipple and dark skin surrounding it -- called the areola -- are reconstructed in a subsequent procedure.

Flap reconstruction
An alternative approach to implant reconstruction involves creation of a skin flap using tissue taken from other parts of the body, such as the abdomen, back or buttocks. In one type of flap surgery, the tissue remains attached to its original site, retaining its blood supply. The flap, consisting of skin, fat and muscle with its blood supply, are tunneled beneath the skin to the chest, creating a pocket for an implant or, in some cases, creating the breast mound itself without need for an implant. Another flap technique uses tissue that is surgically removed from the abdomen, thighs or buttocks and then transplanted to the chest by reconnecting the blood vessels to new ones in that region.

Making the Choice
Breast cancer affects women differently depending on their age, marital status and self-image, as does their attitudes about reconstruction. No matter how they feel about it, Glenn Davis, MD, of Raleigh, N.C., stresses that "every woman should be afforded the choice of undergoing reconstruction as part of her breast cancer treatment, and provided adequate facts to make an informed decision.

Unfortunately, many women are not given the option or the information they need to make an informed decision about reconstruction. According to Christine Horner-Taylor, MD, of Edgewook, Ky., the women who don't undergo reconstruction procedures after losing a breast to mastectomy have many reasons for doing so. "Many women have told me the reason they didn't have breast reconstruction was because their general surgeon didn't recommend it or didn't mention that it could be done at the same time as the mastectomy. If the women are older, their surgeon may have decided they don't really need to go through it," she says.

Other reasons women pass on reconstruction include their unwillingness to have any more surgery than is absolutely necessary and an inability to weigh all the options available while they're struggling to cope with a diagnosis of cancer.

When Reconstruction May Not Be an Option
Not all women are good candidates for breast reconstruction. According to Dr. Horner Taylor, "Women who have had a mastectomy or Lumpectomy with radiation are typically not strong candidates for skin expansion reconstruction. Radiation changes the characteristics of skin tissue, causing a variety of complications ranging from excessive scar tissue development, to blood supply and overall healing problems."

Dr. Davis feels that while radiation does present some difficult challenges, it doesn't automatically rule out the possibility of reconstruction. "While each circumstance is different, I strongly believe that if there is enough good tissue to work with, reconstruction remains a viable option for most women," he says.

Dr. Bruner notes that patients that are emotionally unstable should probably postpone reconstruction. "Coping with the reality of breast cancer is an extremely overwhelming process. If a woman cannot understand the risks and limitations of reconstruction prior to her mastectomy surgery, I would recommend she wait."

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Managing Misconceptions
Misconceptions abound regarding breast cancer reconstruction. "Most misconceptions are fueled by a lack of information," says Dr. Bruner.

Common misconceptions include having to wait up to one year to safely undergo reconstruction, reconstruction makes it difficult to identify cancer if it recurs, and reconstruction interferes with cancer treatments, such as chemotherapy. "Wrong on all counts," says Dr. Horner-Taylor. "Reconstruction can take place immediately following mastectomy with little complication. In the case of implants, reconstruction may take longer if the patient has to undergo chemotherapy, but otherwise doesn't interfere with the process."

Managing Expectations
Managing patient expectations is one of the most important aspects of breast cancer reconstruction. It is important for women to remember that the goal of reconstruction is improvement, not perfection. "Be sure to discuss your expectations candidly with your plastic surgeon, and expect nothing less than total honesty from him or her in return," says Dr. Horner- Taylor. "It's always smart to get the opinions of several plastic surgeons before moving ahead."

To ensure reconstructive surgery has the desired outcome, breast symmetry procedures -- surgery to the other breast --is usually also part of the reconstructive process. "Symmetry procedures either reduce, lift or reshape the remaining breast to ensure a better match to the reconstructed breast," says Dr. Bruner. He goes on to note that symmetry procedures can be an ongoing process, with periodic adjustments necessary to correct the affects of the aging process. ASPRS is currently pushing for legislation to ensure women have access to symmetry procedures as part of their reconstruction treatment after breast cancer.

Dolores Glover, Siebold and Kocsis all decided to undergo reconstruction procedures -- Siebold at the same time as her mastectomy, Glover 10 years later and Kocsis one year later. Glover and Siebold opted for skin expansion with implants. Kocsis decided to go with flap reconstruction.

"Breast reconstruction was the number one motivation that got me through the most difficult times of my treatment," says Siebold. "The breast reconstruction, although excellent, will never look or feel the same as a natural breast. However, not having to stuff my bra with fillers is a great relief and I truly feel like a complete woman again."

Glover was never given the option of reconstruction at the time her cancer was diagnosed and her mastectomy performed. She was 38. "I was so busy being a mom to my two children and a wife that I didn't think about reconstruction initially. I also didn't want to endure any more pain or surgery, although my oncologist strongly recommended it," she says. However, every time she caught a glimpse of herself in the mirror, she was reminded of her disfigurement. "I felt deformed, and that feeling never went away until I had reconstruction. I eventually did use a prosthesis, but still wasn't happy with the results." Ten years after her mastectomy, Glover finally decided to have breast reconstruction. "I'm glad I had it done. It helped me to find closure and feel normal again."

For Kocsis, breast reconstruction was a completely mind restorative process. "The day I had my reconstructive surgery was the day I took my life back," she says. She first learned about flap reconstruction through a local support group and decided to undergo the procedure one year after her diagnosis. "I liked the idea of using natural tissue for the reconstruction, and once I made the decision to have surgery, I actually looked forward to having it done." The reconstruction was a success and Kocsis is thrilled with her results. "I really feel great about my decision and the end result. In fact, my family and I celebrate the date of my surgery every year as my re-birthday." Kocsis is now active in public education efforts for breast cancer and reconstruction, writing articles, conducting interviews and giving presentations.

Davis decided not to undergo reconstruction, although she was prepared to go through with it until the day before her mastectomy. "I just decided that I didn't want to be under anesthesia or on the operating table that long," she says. And five years later, she's confident she made the right decision. "It was more important to me to focus on treating the cancer. My breasts are not that important to me, they don't define who I am as a person."

Making An Informed Decision
The decision to undergo breast reconstruction is an intensely personal one. All of the ASPRS members interviewed for this article agree that the decision should be made by the patient, not by treating physicians. "It really is a quality of life issue," says Dr. Davis. "And it doesn't matter how old the patient is or if they're married or single. All women should have the option, if they want it."

The most important tool available to women coping with breast cancer is information. "Women need to get as much information as they can, from doctors, cancer organizations, support groups and other women," says Dr. Bruner. "And they shouldn't be afraid to ask the tough questions, as many as necessary to increase their comfort level with their treatment and aid in their recovery process."

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An independent National Science Panel appointed by Federal Judge Sam C. Pointer, Coordinating Judge for the Federal Breast Implant Multi-District Litigation, has completed its report, finding no evidence linking silicone breast implants to systemic disease.

The panel of four scientific experts in the fields of immunology, epidemiology, toxicology, and rheumatology was appointed in August 1996 and instructed to review and critique the scientific literature pertaining to the possibility of a causal association between silicone breast implants and connective tissue diseases, related signs and symptoms and immune system dysfunction.

The major findings and conclusions from each of the experts are summarized as follows:

Toxicology: The preponderance of data from these studies indicate that silicone implants do not alter incidence or severity of autoimmune disease. There is no evidence that silicone breast implants precipitate novel immune responses or induce systemic inflammation.

Immunology: There are no consistent data to suggest systemic inflammation or systemic induction of anti-silicone or autoreactive responses in women with silicone breast implants. The main conclusion that can be drawn from existing studies is that women with silicone breast implants do not display a silicone-induced systemic abnormality in the types or functions of cells of the immune system.

Epidermiology: No association was evident between breast implants and any of the individual connective tissue diseases, all definite connective diseases combined, or the other autoimmune/rheumatic conditions. There was no association between silicone gel-filled implants and any of the definite connective tissues or the other autoimmune or rheumatic conditions.

Rheumatology: Many of the rheumatologic complaints reported are common in the general population and as presenting complaints in physicians offices. No distinctive features relating to silicone breast implants could be identified.

ASPRS President Paul Schnur, MD, says, "We are delighted that the findings fully support the plastic surgery-sponsored research. As plastic surgeons our goal has always been to foster scientific investigation of all issues that have been raised about breast implants in order to ensure safety and well-being of our patients. This scientific panelās findings will better enable women to make informed decisions about their own bodies and is of great importance to the more than 1 million women in the United States who have breast implants"

The Executive Summary of the report on "Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction" is available through the ASPRS/PSEF fax back system at 800-333-8835, document number 160. The full 200-page report, can be viewed on the Internet at http://www.fjc.gov/BREIMLIT/md.1926htm.

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