Archives of Surgery, July 2006
By Diana Zuckerman, PhD
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 implant manufacturer Inamed found that 46% of reconstruction patients 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 study had breast implants for an average of only 23 months, compared to 2-3 years in the Inamed study. Henriksen et al reported that 31% developed at least one 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, Henriksen et al did not use Magnetic Resonance Imaging (MRIs) to detect rupture, thus undercounting the number of ruptures according to the FDA.3 A study using MRIs found that 20% of reconstruction patients had ruptured implants by the third year;4 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 was 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 was published after 1999. The IOM report included only 17 studies of autoimmune diseases among implants, almost all of which studied 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 to women with silicone implants without extracapsular leakage.3 The National Cancer Institute (NCI) found a doubling of deaths from brain cancer, lung cancer, and suicides among women with breast implants compared to 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.5,6
The unanswered questions about diseases and the high complication rate for breast cancer patients 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.
1 Henriksen TF, Fryzek JP, Holmich LR et al Reconstructive breast implantation after mastectomy for breast cancer: clinical outcomes in a nationwide prospective cohort study. Arch Surg. 2005; 140: 1152-1159.
2 Inamed Corporation’s McGhan Silicone-Filled Breast Implants, October 14-15, 2003, slides presented by the FDA, http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1_02-update_files/frame.htm
3 Brown SL, Pennello G, Berg WA, et al. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. Journal of Rheumatology. 2001; 28:996-1003.
4 FDA Summary Memorandum, Inamed PMA Review Team, March 2, 2005., http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf
5 Brinton LA, Lubin, JH, Murray MC, et al. Mortality among augmentation mammoplasty patients: an update. Epidemiology. 2006; 17: 162-169.
6 Brinton, LA, Buckley, LM, Dvorkina, O et al. Risks of connective tissue disorders among breast implant patients. American Journal of Epidemiology. 2004, 180: 619-627.