January 2007

What Women Need to Know About Breast Implants

Diana Zuckerman, PhD, Elizabeth Nagelin-Anderson, MA, and Elizabeth Santoro, RN, MPH


In 2005, more than 360,000 women and teenagers underwent surgery to have their breasts enlarged with silicone or saline implants,¹ and experts estimate that about 46,000 breast cancer patients had implant surgery after mastectomy. ² The popularity of breast augmentation has more than tripled since 1997, when there were just over 101,000 of these procedures.³

More than 50,000 implant removal procedures were also reported in 2004.⁴ Given these statistics, it is not surprising that in spite of the increasing number of women with breast implants, debate continues to swirl about their safety. Many women are justifiably confused by the conflicting information they hear. The following summary provides the facts about what is known and not known about the risks of breast implants.

After a brief history of breast implants in the U.S., we will answer the following questions:

• What are the known risks?
• What happens when breast implants break?
• Do breast implants make women sick?
• What are other concerns?
• What if I need to get my implants removed?
• Are there newer, safer implants?

History of Implants in the US

Breast implants made with silicone envelopes and filled with silicone gel or saline (salt water) were first sold in the United States in the 1960's, but sales were relatively slow until the 1980's. By 1990, however, almost one million women had undergone breast implant surgery, even though no safety studies had been published. Most of those women had silicone gel breast implants, which the plastic surgeons preferred. 

Although most medical products must be proven safe and effective before they can be sold in the U.S., that was not true for implanted medical devices sold before 1976.  The Food and Drug Administration (FDA) did not require that companies selling silicone breast implants prove that their implants were safe until 1991 – after they had been in use for almost three decades. For the first time, the media started to report about women with implant problems, and quoted doctors who were concerned about implant safety. When the studies were provided to the FDA, the safety data were found to be inadequate to warrant FDA approval. 

The FDA did not require implant makers to prove that their saline implants were safe until 2000, when, despite high complication rates, the FDA approved saline breast implants for the first time.

Silicone gel breast implants were approved for the first time in November 2006. Between 1992 and 2006, silicone implants were restricted to clinical trials that were primarily for cancer patients and women with broken implants. Patients were required to be informed that the implants were not approved by the FDA and to be regularly evaluated by their plastic surgeons as part of the study, in order to provide safety data intended to help all women with gel implants. Although silicone gel breast implants made by two manufacturers were approved in November 2006, there are still restrictions. For example, they are only approved for women over the age of 22, because younger women are still developing physically and emotionally.

What are the known risks?

Reports of complications among women with implants have been published in medical journals and discussed at public FDA meetings. There are a number of short-term and long-term risks that any woman thinking about getting breast implants or about removing or replacing older implants needs to be aware of.

"Local complications" refer to problems that occur in the breast area that are obviously related to the breast implants or the surgery. Common complications include infection and other surgical risks, chronic breast pain, changes in sensitivity, capsular contracture, breakage and leakage, necrosis (skin death), the need for additional surgery, and "cosmetic" problems (such as dissatisfaction with how the breast looks with the implant).

Studies of saline breast implants and silicone gel breast implants conducted by implant manufacturers have shown that within the first three years, approximately three out of four reconstruction (breast cancer) patients and almost half of first-time augmentation patients experienced at least one local complication – such as pain, infection, hardening, or the need for additional surgery. ⁵

For example, among reconstruction patients:

• 46% of women with silicone gel implants and 21% with saline implants underwent at least one re-operation within three years;
• 25% of silicone patients and 8% of saline patients had implants removed; and
• 6% of silicone patients and 16% of saline patients experienced breast pain. ^{6, 7}  

Complication rates were lower, but still substantial, for augmentation patients. The FDA has a consumer handbook with descriptions of common complications as well as photographs, available to consumers at http://www.fda.gov/cdrh/breastimplants/indexbip.html

In addition to the risks from anesthesia, surgical risks include infection and hematoma (blood or tissue fluid collecting around an implant), both of which can range from mild to severe. Surgical risks are highest immediately around the time of surgery, but complications can require additional surgery later, which will have similar risks to the initial surgery. A woman may need to face these surgical risks several times if she decides to have broken or damaged implants replaced with new ones.

Other local complications include loss of nipple sensitivity or painfully sensitive nipples. Some women are dissatisfied with the cosmetic results of breast implants, because their breasts look or feel unnatural or asymmetrical, or they can hear a "sloshing sound" from saline-filled implants. Problems like these can potentially interfere with sexual intimacy.

Scar tissue that forms naturally around any implant or foreign body can, in some cases, become hard or tight around the implant. This common problem is called capsular contracture. The scar tissue is inside the body, but it can cause the breasts to become very hard and misshaped, and it leads to discomfort that ranges from mild to severely painful.

Several researchers have shown that bacteria or mold can grow in saline implants,⁸ and have expressed concerns about the bacteria or mold being released into the body if the implant breaks. What effect that might have on a woman, or a nursing baby, has not been studied.

What happens when implants break?

All breast implants will eventually break, but it is not known how many years the breast implants that are currently on the market will last. Studies of silicone breast implants suggest that most implants last 7-12 years, but some break during the first few months or years, while others last more than 15 years.

In a study conducted by FDA scientists, most women had at least one broken implant within 11 years, and the likelihood of rupture tends to increase over time.⁹ Silicone migrated outside of the breast capsule for 21% of the women, even though most women were unaware that this had happened.

Implant makers were required to study breakage and provide their studies to the FDA.  Short-term studies of today's saline implants suggest that between 3-9% break within the first three years, and one implant manufacturer's study of their silicone gel implants found that between 3-20% break within three years. ^5,10 A Danish study of ruptured silicone gel implants suggests that most last for ten years, but by the time they are 11-20 years old, most will break, and after 20 years the few that are still intact will break.¹¹

Silicone Migration: Research has shown that silicone gel in implants can break down to liquid silicone at normal body temperatures, and there are reports of silicone leakage and migration from implants to the lymph nodes and other organs.¹² What happens if liquid silicone migrates to the lungs, liver, or other organs? A study published by the Royal Academy of Medicine in Scotland found that a woman with a broken silicone gel implant in her calf was coughing up silicone identical to the kind in her implant.¹³ This has potentially serious implications for women with breast implants, since silicone gel breast implants are considerably larger and closer to the lungs than calf implants.

Do breast implants make women sick?

A more controversial question is whether breast implants cause diseases or illnesses, and not just problems in the breast area.

Auto-immune diseases.  Several reports have concluded that there is no evidence that implants cause systemic disease.^{14, 15, 16} These reports, however, relied on research that focused on autoimmune or connective-tissue diseases in women who had implants for a relatively short time - ranging from a few months to a few years. Since connective-tissue and autoimmune diseases may take many years to develop and be diagnosed, studies that include women who had implants for such a short time cannot be used to determine whether or not breast implants increase the long-term risks of getting these diseases.

Studies conducted after these reports were published indicated that implants may be linked to auto-immune diseases. For example, FDA scientists conducted a study of women who had silicone gel breast implants for at least seven years and found that those with leaking implants were significantly more likely to report fibromyalgia, a painful auto-immune disease.¹⁷  The risk of fibromyalgia remained even after controlling for patient's age, implant age, and implant manufacturer. These researchers also found that women with leaking silicone implants were significantly more likely to report a diagnosis of at least one of the following painful and debilitating diseases: dermatomyositis, polymyositis, Hashimoto's thyroiditis, mixed connective-tissue disease, pulmonary fibrosis, eosinophilic fasciitis, and polymyalgia.

Do implant patients who have auto-immune symptoms feel better if their implants are removed?  A study of 95 women who had silicone gel-filled breast implants and rheumatologic symptoms such as joint pain, found that the symptoms improved in 97% (42 of 43) of the women who had their breast implants removed. In contrast, rheumatologic symptoms worsened in 96% (50 of 52) of the women who did not have their implants removed.¹⁸ In addition, a university researcher has reported that silicone stimulates an immune response, and cellular analyses indicate that these responses are associated with atypical forms of connective tissue disease.¹⁹

A study of Danish women who had breast implants for an average of 19 years found that they were significantly more likely to report fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), and memory loss and other cognitive symptoms, compared to women of the same age in the general population.²⁰

Despite reporting that women with implants were between two and three times as likely to report those symptoms, the researchers, who were funded by a silicone manufacturer, concluded that long-term exposure to breast implants "does not appear to be associated with" autoimmune "symptoms or diseases."

Cancers.  A study by National Cancer Institute (NCI) scientists found a 21% overall increased risk of cancer for women who had implants for at least seven years, compared with women of the same age in the general population.²¹ The increase was primarily due to an increase in brain, respiratory tract, cervical, and vulvar cancers. More research is needed to draw any conclusions, however.  There is no research evidence that implants cause breast cancer. 

Death. A more recent NCI study found that women who had breast implants for at least 12 years were more likely to die from brain tumors, lung cancer, other respiratory diseases, and suicide compared with other plastic surgery patients.²²  Augmentation patients were not more likely to smoke than other plastic surgery patients, so the difference in respiratory diseases did not appear to be due to smoking. However, more research is needed to better control for relevant health habits. Three Scandinavian studies have reported that women who had breast implants for augmentation were three times more likely to commit suicide compared to women in the general population.^{23, 24, 25}

What are other concerns?

Breastfeeding.  According to the Institute of Medicine (IOM), women with any kind of breast surgery, including breast implant surgery, are at least three times as likely to have an inadequate milk supply for breastfeeding.¹⁴ Concerns about the safety of breast milk have also been raised, but there has not been enough research to resolve this issue.  A study of a small number of women with silicone gel breast implants found that the offspring born and breastfed after the mother had breast implants had higher levels of a toxic form of platinum in their blood than offspring born before the same women had breast implants. ²⁶

Breast Cancer Detection.  Breast cancer is the most common type of cancer among women, and since mammograms have been shown to detect breast cancer earlier and thus save lives, the question of whether implants interfere with mammograms is important.

There are several ways in which implants have the potential to delay detection of breast cancer:

• Although mammography can be performed in ways that minimize the interference of the implants, approximately 55 percent of breast tumors will be obscured in women with implants.²⁷
• A study by FDA scientists indicates that silicone or saline implants can rupture when women undergo mammograms, and for this reason, women who fear implant rupture may forego mammograms.²⁸
• The accuracy of mammograms tends to decrease as the size of the implants increase in proportion to the size of the woman's natural breast.      

Research findings on whether implants lead to a delay in breast cancer diagnosis have been inconsistent, but patients have reported such delays.²⁸ A delay in diagnosis could necessitate more radical surgery or be fatal.

Cognitive Problems. Women with implants have raised concerns about memory loss, difficulties with concentration, and other cognitive problems. FDA's analysis of industry data found a significant increase in neurological symptoms, such as poor concentration, for women who had silicone implants for two years compared to their symptoms just prior to getting implants. These differences were maintained even when the women's ages were statistically controlled.²⁹ Some experts believe these symptoms could be related to the small amounts of platinum that are used to make silicone gel breast implants, since potentially toxic levels of platinum have been found in the blood and urine of women with implants.²⁶  Unfortunately, there is no well-designed published epidemiological research to determine whether there is an association between these complaints and breast implants.

Financial Costs. The initial surgery for breast implants is the first, but not always the greatest expense for implant patients. On average, implants last 7-12 years, and each replacement adds to the cost. Even if the implant itself is replaced for free, or if the surgeon offers his or her services for free, the cost of the medical facility, anesthesiology, and other expenses can still cost many thousands of dollars for each surgery.  These expenses are affordable for some women, but not for others, and they are certainly more likely to be burdensome for a woman whose implant breaks after just a few months or years.

When the FDA approved silicone gel breast implants in November 2006, it stated that women with these implants should have a breast MRI three years after getting silicone implants and every two years after that.³⁰ The purpose of the MRIs is to determine if the silicone gel breast implants are ruptured or leaking, because there are often no symptoms. Breast MRIs usually cost at least $2,000, and at some facilities they cost more than $5,000. It is important to remove silicone implants if they are ruptured, to avoid the silicone leaking into the breast or lymph nodes. That is an additional expense of at least $5,000, and can be $10,000 or more.

Saline implants do not require MRIs to check for leakage, and do not usually cost more than $5,000 to remove. The cost of MRIs and the additional cost of removing leaking silicone makes silicone implants substantially more expensive than saline.

What about health insurance? Typically, cosmetic surgery is not covered by health insurance, and problems resulting from cosmetic surgery are also excluded from coverage. Health insurance will not pay for MRIs to check for silicone leakage for augmentation patients. In some states, major health insurance providers do not insure women with breast implants. Some insurers will sell health insurance to women with implants, but charge them more, and some insurers will not cover certain kinds of illnesses - or any problems in the breast area - for women with breast implants. Obviously, this can be a terrible problem for women who are diagnosed with breast cancer or any other illnesses that are excluded, whether or not those diseases are related to the implants.

What if I need to get my implants removed?

Women who have implants sometimes decide to have them removed because of complications, disappointment with the cosmetic result, or, perhaps, concern about the long-term health risks. Some surgeons discourage patients from removing their implants. This may be because they don't share the patient's concerns, or because they know that some patients will be very unhappy with their appearance after the implant is removed. (See photo #3 at www.fda.gov/cdrh/breastimplants/breast_implants_photos.html.) Women with ruptured silicone implants often lose breast tissue as part of the removal surgery. If silicone has leaked into the breast tissue, the resulting removal surgery may be similar to a mastectomy. (See second photo at www.breastimplantinfo.org/what_know/dz_fda_test_oct03.html.)

The plastic surgeon who performed the original surgery is not necessarily the best choice for removing the implant. Removal can be much more complicated and expensive than the original surgery, especially after a silicone gel implant has broken. Some plastic surgeons are very experienced at removal and are especially skilled at getting the best possible cosmetic result. Most surgeons who specialize in removal recommend removing the implants "en bloc," which means that the implant and the intact scar tissue capsule surrounding it are all removed together. This helps remove any silicone that may have leaked from a broken gel implant, and also helps remove silicone or other chemicals that may have "bled" from the silicone outer envelope.

Are there newer, safer implants?

As part of new research studies, plastic surgeons sometimes offer "gummy bear" breast implants, named after gummy bear candies because the implants are a thicker, more cohesive silicone gel. Since the shell and gel in these newer models are thicker than most other silicone gel implants, it is possible that they might be less likely to break or leak into the body.

However, new implants often have risks that are not immediately obvious. Unfortunately, no studies have been published in medical journals to show whether these new implants are proven safer than other silicone gel breast implants for long-term use. At this point, there is no way to know whether the thicker shell will last longer than other implants and if so, whether it will last one year longer or several years longer. Only when the cohesive gel implants are in women for 10 years or more will we know whether and how the implant deteriorates or changes when it is in the human body. These implants have not been approved by the FDA because even less is known about their safety than is known about the older styles of silicone gel breast implants.

Why long-term safety studies matter. In addition to silicone and saline implants, three other kinds of implants were developed in recent years and used primarily outside the United States: Trilucent implants (with soybean oil filler), and Novagold and PIP hydrogel implants, which were filled with a plastic gel.

Although these implants were vigorously promoted by plastic surgeons and the media as a "natural" and safer alternative to silicone or saline implants, clinical trials were apparently never conducted on humans with these implants. By 2000, serious safety concerns resulted in the removal of all three from the market.^{31, 32, 33} The fact that they had been enthusiastically praised by doctors and patients when they were initially introduced serves as a reminder that the long-term risks of implants are not always obvious during the first few years of use. That is why studies of the risks of long-term use - which are still lacking for silicone implants - are essential to establish the safety of all kinds of implants.

Conclusion

Research clearly shows that implants are associated with significant health, cosmetic, and economic risks within the first several years and these risks increase over time. Unfortunately, long-term risks remain unknown because of a lack of careful scientific studies. FDA has required implant manufacturers to conduct additional research to determine why implants break, how long they can be expected to last, and what the longer-term health consequences of broken and leaking breast implants might be. Those studies, however, have not yet been conducted.



References

1 ASAPS 2005 Statistics on Cosmetic Surgery. American Society for Aesthetic Plastic Surgery (ASAPS), Inc., 2005. Available: www.surgery.org.

2 2005 Reconstructive Breast Surgery, American Society of Plastic Surgery (ASPS), Inc., 2005. Available: http://www.plasticsurgery.org/public_education/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=17845 .

3 ASAPS Percent of Change in Select Procedures: 1997-2004.American Society for Aesthetic Plastic Surgery (ASAPS), 2005. www.surgery.org. ASAPS estimates approximately 70,000 more augmentation surgeries in 2004 than does ASPS.

4 ASPS 2000/2002/2003/2004 National Plastic Surgery Statistics: Cosmetic and Reconstructive Procedure Trends. American Society of Plastic Surgeons (ASPS), 2005. www.plasticsurgery.org. ASPS reports more than 164,000 implant removal procedures among augmentation patients between 2000 and 2004.

5 FDA transcript of the Advisory Panel Meeting on Mentor Saline Breast Implants, testimony of Dr. Sahar Dawisha, pages 431-7, 441, at http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3596t1.rtf; FDA transcript of the Advisory Panel Meeting on McGhan Saline Breast Implants, testimony of Dr. Sahar Dawisha, pages 129-148, at http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3596t2.rtf. Local complications are even higher, and tend to be more serious, for women with silicone gel breast implants. See Inamed Corporation’s McGhan, Silicone-Filled Breast Implants, October 14-15, 2003, slides 39-42 and 49-51, at http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1.ppt

6  FDA Summary Panel Memorandum of Inamed PMA, pages 21-22, at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed Panel Memo.pdf. 

7  For a summary of these findings, see Zuckerman D, Santoro E, Hudak N. Silicone Breast Implants: Illnesses and Complications, The Latest Research from Inamed's Core Study at www.breastimplantinfo.org/what_know/oct03_summary.html.

8 Young VL, Hertl, CH, Murray PR, et al. Microbial Growth Inside Saline-Filled Breast Implants. Plastic and Reconstructive Surgery. 1997; 100: 182-196.

9 Brown SL, Middleton MS, Berg WA, et al. Prevalence of Rupture of Silicone Gel Breast Implants Revealed on MR Imaging in a Population of Women in Birmingham, Alabama. Am J Roentgenol. 2000; 175: 1057-1064.

10 FDA Summary Panel Memorandum of Inamed PMA, pages 21-22, at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed Panel Memo.pdf.

11 Holmich L, Friis S, Fryzek J, et al. Incidence of silicone breast implant rupture. Arch Surg, 2003; 138: 801-6.

12 Katzin WE, Centeno JA, Feng LJ. Pathology of lymph nodes from patients with breast implants: A histologic and spectroscopic evaluation. Modern Pathology. 2002; 15: 246A. (abstract).

13 James SE, Tarr G, Butterworth MS, et al. Silicone in the sputum after rupture of a calf implant. J R Soc Med 2001;94:133-134.

14 Bondurant S, Ernster V, Herdman, R, eds. Safety of Silicone Breast Implants. Washington, DC: Institute of Medicine; 1999.

15 "Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction" Summary of Report of National Science Panel. www.fjc.gov/BREIMLIT/SCIENCE/summary.htm.

16 Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000;342:781-790.

17 Brown SL, Pennello G, Berg WA, et al. Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women. J Rheumatology. 2001; 28:996-1003.

18 Aziz NM, Vasey FB, Leaverton PE, et al. Comparison of clinical status among women retaining or removing gel breast implants. Presented at the American College of Epidemiology, 1998.

19 O’Hanlon TP. Restricted and Shared Patterns of TCR b-chain Gene Expression in Silicone Breast Implant Capsules and Remote Sites of Tissue Inflammation. J Autoimmunity. 2000; 14: 283-293.

20 Breiting VB, Holmich, LR, Brandt B, Long-term health status of Danish women with silicone breast implants. Plastic and Reconstructive Surgery. 2004; 114: 217-226.

21 Nyren O, Yin L, Josefsson S, et al. Risk of Connective Tissue Disease and Related Disorders Among Women with Breast Implants: A Nation-Wide Retrospective Cohort Study in Sweden. British Medical Journal. 1998; 316: 417-422.

22 Brinton LA, Lubin, JH, Murray MC, et al. Mortality among augmentation mammoplasty patients: An update. Epidemiology. 2006; 17: 162-9.

23 Koot VCM, Peeters PHM, Granath F, et al. Total and cause specific mortality among Swedish women with cosmetic breast implants: prospective study. British Medical Journal. 2003; 326: 527-528.

24 Pukkala E, Kulmala I, Sirpa-Liis H, et al. Causes of death among Finnish women with cosmetic breast implants. Annals of Plastic Surgery, 2003; 51: 339-42.

25 Jacobsen PH, Holmich LR, McLaughlin JK. "Mortality and suicide among Danish women with cosmetic breast implants." Archives of Internal Medicine. 2004; 164: 2450.

26 Maharaj SVM, & Lykissa ED. Total platinum in urine of women exposed to silicone breast implants and in their children conceived after implantation by ICP-MS. Abstracts of Papers, 230th National Meeting of the American Chemical Society, Washington, DC, United States, Aug. 28-Sept. 1, 2005. American Chemical Society, Washington, DC, 2005; ANYL 510.

27 Miglioretti DL, Rutter CM, Geller BM, et al. Effects of breast augmentation on the accuracy of mammography and cancer characteristics. JAMA, 2004; 291: 442-50.

28 Brown SL, Todd JF, and Luu HD, Breast Implant Adverse Events during mammography: Reports to he Food and Drug Administration, Journal of Women's Health 2004, 13: 371-378

29 Inamed Corporation’s McGhan, Silicone-Filled Breast Implants, October 14-15, 2003, slides #45 and #55, at http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1.ppt.

30 Important Information for Women About Breast Augmentation with Inamed Silicone Gel-Filled Implants, http://www.fda.gov/cdrh/pdf2/P020056d.pdf  [For other identical MRI warnings for Mentor and reconstruction patients, see http://www.fda.gov/cdrh/breastimplants/labeling.htm]

31 UK Department of Health, Medicines and Healthcare Products Regulatory Agency. "Device Alert - Breast Implants: NovaGold." UK: Medical Devices Agency. www.medical-devices.gov.uk/.

32 Laurance J, "Agonizing wait for 5,000 women told that their breast implants might leak and cause cancer." The Independent, 7 June 2000. www.independent.co.uk/story.jsp?story=5864.

33 "Statement on the Safety of Trilucent Breast Implants." UK: Medical Devices Agency. www.medical-devices.gov.uk/.