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Reconstructive Breast Implantation After Mastectomy

Reconstructive Breast Implantation After Mastectomy Henriksen et al1 provided useful data on the short-term complications of breast reconstruction with implants. Although the invited critique described the complication rate as “alarmingly high and arguably unacceptable,” the complication rate is even higher in other studies with superior study designs. For example, a study conducted by the implant manufacturer Inamed found that 46% of patients with reconstruction needed additional surgery within the first 2 to 3 years after getting silicone gel breast implants2—more than twice as high as the 21% reported by Henriksen et al. One explanation is that the women in the Henriksen et al study had breast implants for an average of only 23 months, compared with 2 to 3 years in the Inamed study. Henriksen et al reported that 31% developed at least 1 serious complication and 16% developed at least 2 serious complications. The Inamed study reported that 25% underwent implant removal, 16% experienced Baker III-IV capsular contracture, 6% experienced necrosis, 6% had breast pain, and 6% had scarring, in addition to infections and other complications.2 Henriksen et al concluded that “reconstruction failure (loss of implant) is rare.” However, in addition to the short follow-up period, Henriksen et al did not use magnetic resonance imaging (MRI) to detect rupture, thus undercounting the number of ruptures according to the Food and Drug Administration.3 A study using MRIs found that 20% of patients with reconstruction had ruptured implants by the third year4; very few ruptures were detected without MRIs. Food and Drug Administration scientists concluded that the risk of rupture would likely increase exponentially every year. Henriksen et al's lack of MRI use also helps explain the lower rate of additional surgery. If a woman underwent an MRI and learned that her implant had ruptured, she would probably have surgery to remove it. In his critique, Singh states that “the immunologic and systemic complications ascribed to implants (silicone or saline) have been debunked by the Institute of Medicine's 1999 definitive report.” However, most research on diseases among implant patients has been published after 1999. The Institute of Medicine report included only 17 studies of autoimmune diseases among implant patients, almost all of which studied relatively small numbers of women for short periods of time. Many of the studies reported higher levels of disease or symptoms among women with breast implants, which would have reached statistical significance if maintained in larger studies conducted for a longer period of time. For example, the study by Schusterman et al included only 250 women with implants, all of whom had implants for 2 years. In 2001, Food and Drug Administration scientists reported a significant increase in fibromyalgia and several other autoimmune diseases among women whose silicone gel breast implants were leaking, compared with women with silicone implants without extracapsular leakage.3 The National Cancer Institute found a doubling of deaths from brain cancer, lung cancer, and suicides among women with breast implants compared with other plastic surgery patients.5 National Cancer Institute findings regarding autoimmune diseases were not definitive.6 National Cancer Institute scientists concluded that more research was needed to determine if implants increase the risk of cancer or autoimmune diseases.4,5 The unanswered questions about diseases and the high complication rate for patients with breast cancer raise important safety issues about breast implants. It is difficult for patients to receive informed consent when definitive long-term data are not yet available. Correspondence: Dr Zuckerman, National Research Center for Women and Families, 1701 K St NW, Suite 700, Washington, DC 20006 (ads@center4research.org). References 1. Henriksen TFFryzek JPHolmich LR et al. Reconstructive breast implantation after mastectomy for breast cancer: clinical outcomes in a nationwide prospective cohort study. Arch Surg 2005;1401152- 1159PubMedGoogle ScholarCrossref 2. Inamed Corporation's McGhan Silicone-Filled Breast Implants, October 14-15. Food and Drug Administration Web site. http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1_02-update_files/frame.htm. Accessed January 3, 2006 3. Brown SLPennello GBerg WA et al. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol 2001;28996- 1003PubMedGoogle Scholar 4. Summary memorandum panel. Food and Drug Administration Web site. http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf. Accessed January 3, 2006 5. Brinton LALubin JHMurray MC et al. Mortality rates among augmentation mammoplasty patients: an update. Epidemiology 2006;17162- 169PubMedGoogle ScholarCrossref 6. Brinton LABuckley LMDvorkina O et al. Risks of connective tissue disorders among breast implant patients. Am J Epidemiol 2004;160619- 627PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Surgery American Medical Association

Reconstructive Breast Implantation After Mastectomy

Archives of Surgery , Volume 141 (7) – Jul 1, 2006

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Publisher
American Medical Association
Copyright
Copyright © 2006 American Medical Association. All Rights Reserved.
ISSN
0004-0010
eISSN
1538-3644
DOI
10.1001/archsurg.141.7.714-b
Publisher site
See Article on Publisher Site

Abstract

Henriksen et al1 provided useful data on the short-term complications of breast reconstruction with implants. Although the invited critique described the complication rate as “alarmingly high and arguably unacceptable,” the complication rate is even higher in other studies with superior study designs. For example, a study conducted by the implant manufacturer Inamed found that 46% of patients with reconstruction needed additional surgery within the first 2 to 3 years after getting silicone gel breast implants2—more than twice as high as the 21% reported by Henriksen et al. One explanation is that the women in the Henriksen et al study had breast implants for an average of only 23 months, compared with 2 to 3 years in the Inamed study. Henriksen et al reported that 31% developed at least 1 serious complication and 16% developed at least 2 serious complications. The Inamed study reported that 25% underwent implant removal, 16% experienced Baker III-IV capsular contracture, 6% experienced necrosis, 6% had breast pain, and 6% had scarring, in addition to infections and other complications.2 Henriksen et al concluded that “reconstruction failure (loss of implant) is rare.” However, in addition to the short follow-up period, Henriksen et al did not use magnetic resonance imaging (MRI) to detect rupture, thus undercounting the number of ruptures according to the Food and Drug Administration.3 A study using MRIs found that 20% of patients with reconstruction had ruptured implants by the third year4; very few ruptures were detected without MRIs. Food and Drug Administration scientists concluded that the risk of rupture would likely increase exponentially every year. Henriksen et al's lack of MRI use also helps explain the lower rate of additional surgery. If a woman underwent an MRI and learned that her implant had ruptured, she would probably have surgery to remove it. In his critique, Singh states that “the immunologic and systemic complications ascribed to implants (silicone or saline) have been debunked by the Institute of Medicine's 1999 definitive report.” However, most research on diseases among implant patients has been published after 1999. The Institute of Medicine report included only 17 studies of autoimmune diseases among implant patients, almost all of which studied relatively small numbers of women for short periods of time. Many of the studies reported higher levels of disease or symptoms among women with breast implants, which would have reached statistical significance if maintained in larger studies conducted for a longer period of time. For example, the study by Schusterman et al included only 250 women with implants, all of whom had implants for 2 years. In 2001, Food and Drug Administration scientists reported a significant increase in fibromyalgia and several other autoimmune diseases among women whose silicone gel breast implants were leaking, compared with women with silicone implants without extracapsular leakage.3 The National Cancer Institute found a doubling of deaths from brain cancer, lung cancer, and suicides among women with breast implants compared with other plastic surgery patients.5 National Cancer Institute findings regarding autoimmune diseases were not definitive.6 National Cancer Institute scientists concluded that more research was needed to determine if implants increase the risk of cancer or autoimmune diseases.4,5 The unanswered questions about diseases and the high complication rate for patients with breast cancer raise important safety issues about breast implants. It is difficult for patients to receive informed consent when definitive long-term data are not yet available. Correspondence: Dr Zuckerman, National Research Center for Women and Families, 1701 K St NW, Suite 700, Washington, DC 20006 (ads@center4research.org). References 1. Henriksen TFFryzek JPHolmich LR et al. Reconstructive breast implantation after mastectomy for breast cancer: clinical outcomes in a nationwide prospective cohort study. Arch Surg 2005;1401152- 1159PubMedGoogle ScholarCrossref 2. Inamed Corporation's McGhan Silicone-Filled Breast Implants, October 14-15. Food and Drug Administration Web site. http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1_02-update_files/frame.htm. Accessed January 3, 2006 3. Brown SLPennello GBerg WA et al. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol 2001;28996- 1003PubMedGoogle Scholar 4. Summary memorandum panel. Food and Drug Administration Web site. http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf. Accessed January 3, 2006 5. Brinton LALubin JHMurray MC et al. Mortality rates among augmentation mammoplasty patients: an update. Epidemiology 2006;17162- 169PubMedGoogle ScholarCrossref 6. Brinton LABuckley LMDvorkina O et al. Risks of connective tissue disorders among breast implant patients. Am J Epidemiol 2004;160619- 627PubMedGoogle ScholarCrossref

Journal

Archives of SurgeryAmerican Medical Association

Published: Jul 1, 2006

Keywords: breast implantation,mastectomy

References