Diana Zuckerman, Ph.D.
The complication rate for getting breast implants after mastectomy has been described by experts as “alarmingly high and arguably unacceptable,”1 even though most of the information about complications is based on studies that were paid for by companies that make breast implants or silicone.
How safe are breast implants and how many women have complications after getting reconstruction with breast implants after a mastectomy? When the Food and Drug Administration (FDA) approved breast implants, they acknowledged that the complication rate is very high for all women, especially those undergoing reconstruction. What the FDA did not know, however, is that early-stage breast cancer patients that undergo mastectomy and reconstruction with breast implants are 10 times as likely to commit suicide as other early-stage breast cancer mastectomy patients.
We do not know why the suicide rate is so high for mastectomy patients with breast implants, but we do know that complications are very common. For example, a study conducted by implant manufacturer Inamed (now called Allergan) found that 46% of reconstruction patients needed additional surgery within the first 2 to 3 years after getting silicone gel breast implants 2. Not surprisingly, the implant maker did not publish an article describing this high complication rate, which was more than twice as high as the 21% reported by Henriksen and his colleagues in their study funded by Dow Corning (which manufactures silicone).
Why was the complication rate lower in the Dow Corning study? One explanation is that the women in that study had breast implants for an average of only 23 months, compared to 2-3 years in the Inamed study. Even so, the Dow study found that 31% of the women developed at least one serious complication and 16% developed at least 2 serious complications in that short period of time. The Inamed study reported that 25% underwent implant removal, 16% experienced Baker III-IV capsular contracture (which is painful breast hardness), 6% experienced necrosis (death of breast tissue), 6% had other types of breast pain, and 6% had an implant that ruptured, and other women reported infections and other complications.2 This shows that both studies found very high complication rates despite a short follow-up of less than 3 years.
In their Dow-funded study, Henriksen concluded that “reconstruction failure (loss of implant) is rare.” Of course, it should be rare after less than 2 years. In contrast, when Inamed used Magnetic Resonance Imaging (MRIs) to detect rupture, they found that 20% of reconstruction patients had ruptured implants by the third year;3 while very few ruptures were detected without MRIs. Since Henriksen did not use MRIs to detect rupture, he probably undercounted the number of failed implants. Moreover, FDA scientists concluded that the risk of rupture would likely increase exponentially every year.4
The lack of MRI use also helps explain the lower rate of additional surgery for the Henriksen study. If a woman underwent an MRI and learned that her implant was ruptured, she would probably have surgery to remove it.
Many plastic surgeons claim that the Institute of Medicine concludes that breast implants are safe. However, the Institute of Medicine report was completed in 1999, and most research on breast implant patients was published after 1999, making the report very outdated. Many of the studies reported higher levels of diseases or symptoms among women with breast implants, which would have reached statistical significance if the studies were larger and women were followed 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 only 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 that were not leaking outside the scar tissue capsule.4 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 with breast implants raise important safety issues. It is difficult for patients to receive informed consent when few studies of breast cancer reconstruction patients are available.
An earlier version of the above article was based on Dr. Zuckerman’s article published in Archives of Surgery, Vol 141, July 2006, pages 714-715. The original article can be found here.
- style=”color: black;”>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. ▲
- style=”color: black;”>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 target=”_blank”>http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1_02-update_files/frame.htm, slide 49. ▲
- 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 ”_blank”>http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf ▲
- 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 ▲
- Brinton LA, Lubin, JH, Murray MC, et al. Mortality among augmentation mammoplasty patients: an update. Epidemiology. 2006; 17: 162-169. ▲
- 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. ▲