The Mayo Clinic epidemiologic study (published in the New England Journal of Medicine). 30-year retrospective study found no association between silicone breast implants and Connective Tissue Disorders (CTDs) and other disorders that were studied. The study represents more than 20,000 years of patient follow-up.
The Danish Registry for Plastic Surgery of the Breast registered 1,240 women who received breast implants for the first from June 1999 to November 2001 and shows that a low number of silicone and saline implant recipients experience complications.
85% received breast implants for augmentation and 15% had breast reconstruction following mastectomy; 88% were silicone gel.
16% experienced complications (the majority of which was change in feeling)
4% (of the 16%) had capsular contracture, the majority of which were categorized as minor; and 1% (of the 16%) required additional surgery.
American College of Rheumatology issues a statement saying the
evidence is "compelling" that implants did not cause systemic disease.
The Harvard Nurses Epidemiologic Study conducted over a 14-year period finds no increased risk of connective-tissue disease or certain signs and symptoms of connective-tissue disease in women with silicone implants.
The American Academy of Neurology reviews existing silicone implant studies and reports that "existing research shows no link between silicone breast implants and neurological disorders."
Institute of Medicine: Women who have silicone breast implants are no more likely than the rest of the population to develop cancer, immunological diseases or neurological disorders. The Institute of Medicine is part of the National Academy of Sciences, the nation's most prestigious scientific organization.
FDA Confirming earlier breast implant research, the FDA study found silicone implants
can break. However, even after the breast implants break, there
are no symptoms.
FDA Report on Allergan Inamed® Silicone Breast Implants
FDA on Breast Implant Risks Here
FDA Breast Implant Timeline Here
The most comprehensive study of its kind: researchers from the University of North Carolina reviewed 20 studies involving 10,000 women with gel implants from the United States, Sweden, the Netherlands, Canada, the United Kingdom and Australia. The researchers could find no link between gel implants and autoimmune diseases.
American Society of Plastic and Reconstructive Surgeons said the FDA, which banned implants in 1992, is rethinking the issue because recent scientific studies have failed to show a link between implants and diseases.
The Journal of the National Cancer Institute publishes a review of scores of medical studies that concludes breast implants do not cause breast cancer.
Department of Immunology and Microbiology, Wayne State University Medical School, Detroit. RESULTS: No adverse influence of silicone gel or silicone oil on the clinical aspects of lupus was observed.
Arthritis Research Center and University of Kansas School of Medicine, Wichita, KS. Abstract: Silicone filled breast implants and the risk of fibro-myalgia and rheumatoid arthritis. RESULTS: No association between Silicone Breast Implants and RA was found. No association between prior Silicone Breast Implants and subsequent FM was found.
Department of Pathology, Baylor College of Medicine, Houston, TX: "Pathologic findings in nerve and muscle biopsies from 47 women with silicone breast implants" CONCLUSION: These findings do not support a consistent association between Silicone Breast Implants and any neuro-pathologic entity.
Department of Medicine, Multipurpose Arthritis and Musculoskeletal Diseases Center, Harvard Medical School. "Association of silicone breast implants with immunologic abnormalities" CONCLUSION: We found no increased frequency of any immunologic abnormalities in women exposed to silicone breast implants, except for anti-ssDNA, which has unknown clinical relevance.
American Society of Plastic Surgeons and American Society for Aesthetic Plastic Surgery. The results of more than 20 important epidemiologic studies of Connective Tissue Disorders 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.
An Independent National Science Panel appointed by Federal District Judge Sam C. Pointer, Coordinating Judge for the Federal Breast Implant Multi-District Litigation, released a report on December 1, 1998, which found no evidence linking silicone breast implants to systemic disease.
American Academy of Pediatrics: Children of women with silicone breast implants have no increased risk of esophageal disorders or autoimmune disease.
University of Kansas: study of 2,304 women, showed that women with implants are no more likely to develop fibro-myalgia or rheumatoid arthritis than are women in the general population.
University of Texas M.D. Anderson Cancer Center concluded, "The incidence of autoimmune disease in mastectomy patients receiving silicone gel implants is not different than in patients who had reconstruction with autogenous tissue."
The National Cancer Institute and FDA found that women with breast implants are not at increased risk for breast cancer.
Western Journal of Medicine found no evidence linking silicone breast implants with connective tissue diseases.
Scientific American "Silicone Safe" A major report finds that silicone breast implants don't lead to cancer.
UK Study: It is concluded that claims that silicones themselves provoke antibody responses in vivo are not sustained by present evidence reported in the scientific literature.
Two large Scandinavian studies fail to show that silicone implants are linked to neurological disease.
Germany Federal Institute for Drugs & Medical Devices: Holds the view that a general ban of silicone-gel breast implants is not necessary.
European Committee on Quality Assurance of Medical Devices in Plastic Surgery: Currently available data indicate that silicone breast implants do not cause cancer nor other malignant diseases. Silicone breast implants do not cause identified and recognized auto-immune diseases nor connective tissue diseases.
Danish Cancer Society: Included four separate groups of women (1,135 w/ breast implants for cosmetic purposes; 1,435 w/ implants for breast reconstruction; and two non-implanted control groups totaling 11,023 women who had either breast reduction or breast cancer surgery). The study found no statistically "significant excess of definite connective-tissue disease."
University of Calgary in Alberta, Canada: A study of 1,601 women at the University showed no increased levels of auto-antibodies among women with implants.
British Department of Health concludes that none of the studies it has reviewed "demonstrated that the coexistence of connective tissue disease with silicone gel breast implants is any more prevalent that would be expected by chance."
University of Washington Fred Hutchinson Cancer Research Center found "no increased risk for rheumatoid arthritis among women with silicone breast implants."
Scottish Study in 1994 (also published in Plastic and Reconstructive Surgery) compared 317 women with silicone-filled breast implants over a 10 year period with women without breast implants. Average follow-up period was 5.66 years. The study concluded, "no differences were found in the symptoms or physical signs of connective tissue diseases between the study patients and their controls. This study has failed to find any case for a link between silicone gel-filled breast implants and connective tissue diseases."
Canadian Study in 1996 (also published in The Journal of Rheumatology) 1,576 women including 1,112 who had silicone breast implants between 1978 and 1986. "The results of this study do not support the hypothesis that silicone gel-filled implants induce or promote CTD." Targeted conditions included rheumatoid arthritis, systemic lupus erythematosus, scleroderma and Sjögren's syndrome.
On Trial: Medical Evidence and the Law in the Breast Implant Case
by Marcia Angell, MD, executive editor of the New England Journal of Medicine and author of Science on Trial, examines the history and causes of the silicone breast implant controversy.
OnHealth w/ WebMD "Breast implants not to blame for illnesses"
The Cleveland Clinic "Breast Implants and Safety" states there is no convincing scientific evidence associating these implants with connective tissue disease.
The Medical Journal of Australia states, ". . . there is no strong link between silicone breast implants and connective-tissue diseases or symptoms."
Frontline Implants on Trial
The National Center for Public Policy Research: Vice President, Amy Ridenour says, "medical research money should be spent where it can do the most good [not on implants]."
Over the years, Mentor has done a very thorough safety evaluation of both saline-filled breast implants and gel-filled breast implants. In addition, Mentor has sponsored other state-of-the-art tests performed at leading academic institutions. The largest of these studies is a clinical study of more than 70,000 women with silicone gel-filled breast implants. This study was established by Mentor in 1992 in cooperation with the U.S. Food and Drug Administration (FDA).
Mentor also has conducted extensive investigations of saline-filled breast implants involving nearly 5,000 patients. The general objective of these studies was to gather information about the safety and effectiveness of breast implants. Mentor saline breast implants have received PMA (premarket application) approval from the FDA. For more see Mentor
Silicone Gel Clincial Studies
About Cohesive Silicone Gel Implants
Currently, all silicone gel implants in the Unites States are cohesive polymers, not liquids. This means that the gel filler acts as a solid unit rather than a liquid. The gels hold together uniformly, while retaining the natural "give" that resembles actual breast tissue.
Silicone Breast Implant Info
After years of waiting, silicone implants are back. Since 1992 there has been a ban imposed by the FDA on the sale of silicone gel implants. Women wanting silicone implants, since then, have had to “ qualify “ for the implants by meeting specific criteria to be included in a study. The ban was imposed due to claims of a connection between silicone gel breast implants and autoimmune diseases, connective tissue diseases and even cancer. Scientific evidence since that time conducted by the Institue of Medicine and experts from all over the world has shown no such connection to exist. In July of 05’ a letter was sent by the FDA to a silicone implant manufacturer stating that silicone implants could be used if certain criteria were met. And as of last week, November 2006, silicone implants are available to all breast reconstruction and revision patients, as well as women 22 years of age and older seeking cosmetic breast enhancement. A number of conditions come attached to the approval, including studies and follow-up.
So what’s different about these implants? In the 70’s and 80’s silicone implants were made of a more liquid consistency. Since the early 90’s implants are made of what is called a cohesive gel. That is the silicone in these implants is more cohesive or stable in form. If one of these implants is cut the implant for the most part will maintain it’s shape and not leak out. The shells of the implants in the 70 and 80’s were thinner and more likely to leak. The implants today have shells that are made of several layers. This makes the implants feel more firm but help cut down on gel bleed. Gel bleed is the term that describes small amounts of the silicone moving through the shell. Although these implants are firmer than the implants of the past they are still softer in feel in comparison to saline. The so called “ gummy bear “ implants are also a cohesive gel implant. These are even more cohesive than the standard gel implants and therefore maintain there shape more. Due to the added firmness, the incision much be larger and the shape of the implant is an anatomical shape. These implants are currently being used in Europe, and may have more use in reconstructive type cases.
Saline implants are the salt water filled implants that have been used in place of silicone implants, since the silicone ban. Now in addition to the choices of size, shape, shell type, incision site, location ( above or below the muscle ), patients will have to choose between silicone and saline implants.
So what are the advantages and disadvantages of silicone implants?
The main advantage of the silicone implants is that they have a more natural feel and less visible rippling. Breast implants have transverse creases which form around the edge know as rippling. Although silicone implants have this also it is far less evident when compared with the saline implants. This will be particularly important for women who have thin skin, perhaps after childbirth and breast feeding, or for women with extremely small breasts. For women with at least a B cup or with thicker firmer breast tissue rippling will most likely not be an issue. However, the silicone implants will have a softer feel.
The disadvantages of the silicone implants are that they come pre-filled. This means the incision sites have to be larger and the surgeon won’t be able to adjust the implants after inserting them. For example a mentor 450 saline moderate plus has a fill range between 450- 540 cc’s. This means the implant can be filled anywhere in this range depending on the type of look and size the patient wants and also to gain symmetry between the breasts. With the silicones the next size up after 450 is a 500 cc implant. So the surgeon will have less flexibility with the silicone implants. And because the implants come pre-filled the umbilical method is not an option with the silicone implants, and the incisions in the other locations will have to be slightly larger. Also, for patients with small areola, who want to go large, the inframammary fold incision may have to be used. This is because it may not be possible to squeeze a large implant through very small areola or through the armpit. Capsular contracture may be more common with silicone implants. Most of the studies, however, were with the older, thinner shelled implants and therefore may not be accurate. Leaks may be diffiucult to detect and it may be necessary to get routine MRI exams every few years to rule out a leak. With saline implants a leak will be very obvious as the breast will appear significantly smaller than it’s original size. And finally, the cost of the silicones is much greater compared to the saline implants.
So, which implant will be better for you? Well, that will be up to you and your surgeon to decide. You will have to take into consideration how much breast tissue you have, what is the quality of your breast tissue, how large you want to go, how important scarring is to you, how important the feel of the breast is to you, and how much your budget allows you to spend. Silicone implants are definitely softer in feel and will have a significant difference in patients with thin skin / breast tissue. But in patients with thicker skin and more breast tissue this difference will be less noticeable. The implant company you use will also affect the feel, as certain implant companies will have a softer feel to their shell, and therefore a softer feel overall.
The important thing is to go to someone who is board certified by the American Board of Plastic Surgery. Preferably someone with experience with both saline and silicone implants and all the different methods of insertion. Being certified by the ABPS, and only the ABPS, will guarantee that your surgeon is a true plastic surgeon trained in breast surgery and passed all the requirements of the certification process.
True Experiences with Silicone Breast Implants
I have had silicone implants for 15 years with no repeat surgeries, no complications. Anyone else out there with a similar story. I have had 2 mammograms and there has been no apparent leakage. I rarely get sick and have no strange maladies. I hope this gives encouragement to other women. ~Patricia
TRIAL OF COHESIVE GEL BREAST IMPLANT
Silicone-Filled Breast Implant to be Studied in 30 Years
IRVINE, CA, April 19, 2001 - The Food and Drug Administration (FDA) has approved a clinical trial of the first new silicone-filled breast implant in more than 30 years, the Women's Implant Information Network announced today. The study, which will begin in early Spring, will examine the safety and efficacy of the Inamed (formerly McGhan) Style 410 implant for breast augmentation or breast reconstruction following mastectomy.
The new device, which has been marketed in Europe since 1993, is filled with a unique, cohesive silicone gel that is designed to prevent leakage or migration of the gel. The implant's natural, curved profile shape is maintained by the cohesive gel, and the implant has orientation marks to assist the physician with visual and/or tactile placement during surgery.
"Silicone implants are preferable to saline for a natural look and feel," said Sandra Finestone of the Women's Implant Information Network (WIIN). "This study is important because women seeking breast augmentation and reconstruction deserve the most advanced technologies available."
A total of 440 were enrolled in the multi-center study, with half the subjects undergoing augmentation and half undergoing breast reconstruction. Patients will be evaluated pre-, intra- and post-operatively, and annually for 10 years following surgery.
Dr. John B. Tebbetts, F.A.C.S., a Dallas-based plastic surgeon, designed the new implant and will personally investigate 55 primary cosmetic augmentation cases in the study.
"It is important to develop and study new options for women. The silicone implants currently used in surgeries in the U.S. were designed 30 years ago," Dr. Tebbetts says.
He is the only physician in the U.S. who has long-term experience using the Style 410 in breast augmentation. He implanted the device in more than 60 augmentations in Europe over five years ago, and has tracked patient progress since the surgeries.
Silicone breast implants have been used since the early 1960s for breast augmentation and reconstruction. The safety of silicone-based implants was confirmed in 1998, when the National Academy of Sciences Institute of Medicine (IOM) published a study evaluating the evidence of an association of silicone breast implants with human health conditions. Of the 1.5 to 1.8 million women with silicone implants in the U.S., the report concluded that immunological diseases, cancer, neurological diseases, and other systemic conditions did not appear to be increased in women with breast implants when compared to women without breast implants.
According to the American Society of Plastic Surgeons, use of breast implants has increased 101 percent since 1997. Last year, more than 200,000 women underwent breast reconstruction or augmentation.
Surgical techniques for breast augmentation have advanced significantly over the past several years. "Precise dissection techniques improve the patient's overall experience," says Dr. Tebbetts. "Because of these less-traumatic techniques, the need for special brassieres, bandages and draining is eliminated, and over 95 percent of patients are back to normal activities within 24 hours. That is a drastic change from traditional breast augmentation, which requires up to two weeks to return to normal activities."
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