Diana Zuckerman, PhD
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 after a mastectomy. 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.
Complications from Implants
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 in a study funded by a company that makes silicone (Dow Corning).1
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.
The Dow-funded study 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 but very few ruptures were detected without MRIs. Since Henriksen did not use MRIs. Since the Dow Corning study did not use MRIs to detect rupture, they couldn’t accurately count the number of failed implants. Moreover, FDA scientists concluded that the risk of rupture would likely increase exponentially every year.4
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, years before most research was conducted. 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.
Can implants cause cancer or other serious diseases?
Experts around the world now agree that breast implants can cause a type of cancer of the immune system called ALCL (anaplastic large cell lymphoma). In fact, there is now a specific diagnosis called breast implant associated ALCL (BIA-ALCL). If caught early, removal of the breast implants can be very effective, but if not treated quickly it can be fatal. 5
The link between breast implants and other cancers remains controversial. Studies paid for by plastic surgeons or implant companies tend to conclude that breast implants are safe. Since breast implants can cause cancer of the immune system, it seems logical that implants might have an impact on other diseases of the immune system or other cancers. For example, FDA 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 In addition, scientists at 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.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 Bottom Line
Many women choose mastectomies to “get rid of the cancer once and for all” hoping that it is the safest strategy for dealing with breast cancer. However, research shows that women who have lumpectomies live longer than women with the same diagnoses that chose mastectomies instead. Research makes it clear that there are many complications from breast implants that often keep women needing additional surgery and medical help in the years after breast cancer is removed, including the possibility of cancer of the immune system. Unfortunately, many women tell us that their doctors did not warn them about these risks. [Read a New York Times article about a woman with ALCL here.]
Some of the information from this article was based on Dr. Zuckerman’s article published in Archives of Surgery, Vol 141, pages 714-715. The original article can be found here.
- 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. ▲
- Inamed Corporation’s McGhan Silicone-Filled Breast Implants, October 14-15, 2003, slides presented by the FDA, href=”http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1_02-update_files/frame.htm”>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 ▲
- Miranda, R., Aladily, T., Prince, H., et. al. (2013). Breast Implant-Associated Anaplastic Large-Cell Lymphoma: Long-term Follow Up of 60 Patients. Journal of Clinical Oncology. ▲
- Brinton LA, Lubin, JH, Murray MC, et al. Mortality among augmentation mammoplasty patients: an update. Epidemiology. 2006; 17: 162-169. ▲