Safety FAQ

Perhaps the two most frequently asked questions about breast implants are "Are they safe?" and "How much do they cost?" The short answer to the first question is "Yes" - implants are, for the most part, a safe option for women who are interested in breast augmentation or reconstruction. The long answer requires a more comprehensive understanding of the history of breast implants. (For more information on the second question, read about Breast Implant Costs.)

Before the modern breast implant entered the scene, women attempted to augment their breasts by having different substances – most often silicone – injected.  Many of these women developed granulomas (bunches of immune cells) and, as a result, required mastectomies.  This clearly raised concerns about the use of silicone in the body in general.  Numerous other items were (unsuccessfully and sometimes disastrously) tried as filler.  Some pioneering surgeons also attempted breast enlargement by adjusting the tissues on the patient’s chest to enhance the volume of the breast. 

The implant as we now know it (that is, a shell filled with a substance) was invented in the early 1960s by doctors Frank Gerow and Thomas Cronin.  These physicians were working at the University of Texas in Houston at the time, which is why Houston sometimes has the nickname “Silicone City.”  The original implant, known as the Cronin-Gerow implant, had a thick silicone shell and was filled with thick, cohesive silicone gel. Another feature of the original silicone implants was a set of patches on the side that faced the chest; the purpose of these patches was similar to that of Velcro - to keep the implant from rotating after placement. These were eventually removed as advances in surgical procedures made them unnecessary. Originally intended for reconstruction after mastectomy (i.e., as a prosthesis), these implants also attracted the attention of women who were interested in enhancing their busts. However, despite being the product of a decade of research, these implants were criticized for looking and feeling somewhat unnatural.

Saline implants appeared in 1964 in France as an alternative to silicone implants; these implants could be filled after being placed, which meant that the incision could be much smaller than that necessary for silicone implants.   In 1968, Dow Corning (then a manufacturer of implants) introduced a new silicone implant with a thinner, seamless lining and a modified filler gel that more closely resembled breast tissue. Although this second-generation implant reduced some (but not all) of the complaints about its predecessor, it created a new problem caused by the thinner lining: leaks. The models that followed (that is, third and fourth generation breast implants) attempted to eliminate this issue while simultaneously making the implants look and feel more like the real thing.

In the 1990s, the Food and Drug Administration (FDA) banned silicone implants for new breast enlargement procedures because of a growing concern that a relationship between silicone implants and connective tissue and auto-immune diseases (e.g., lupus, arthritis) might exist.  Although there was no clear evidence that silicone implants were safe, there was also no clear data to suggest that they were not safe.  Silicone implants could still be used for reconstruction, replacement, and select other reasons, but throughout the 1990s and early 2000s, saline implants overwhelmingly dominated the implant market. The ban simply reflected the FDA’s understandably cautious approach to products that could have an impact on public health.  In response, over the next decade, manufacturers and scholars alike attempted to determine whether silicone breast implants did indeed pose a health threat to women.  In 2006, manufacturers again approached the FDA with more data – enough that the FDA felt it had sufficient proof that silicone implants were safe, and the FDA lifted the ban, allowing them to the market. 

In 2011, the FDA updated the safety information about breast implants in general.  Recent research has suggested a potential connection between breast implants and anaplastic large cell lymphoma (ALCL), which is an extremely rare (that is, estimated to affect 1 in 500,000 American women annually) type of non-Hodgkin’s lymphoma – a cancer that affects the immune system.  ALCL located in the breast is an even less common phenomenon with as few as 3 out of 100,000,000 (yes, million!) American women receiving this diagnosis each year.  Importantly, this finding applies to both silicone gel and saline implants, which raises the question of whether the procedure could be contributing to this increased risk as much as the implants themselves.  However, although the risk is elevated, it is still considered to be small.  To put this in perspective, the FDA has knowledge of about 60 total ALCL cases in women with breast implants around the world; however, the total number of breast implants worldwide is estimated to be somewhere between 5 million and 10 million (so 60 cases out of an average of 7.5 million).  Although there may be other unreported cases, the FDA did not consider this research sufficient evidence to withdraw breast implants from the market, but it will continue to monitor the situation and take the necessary steps to update consumers and physicians as new data emerges.

Modern implants have multiple layers in the shell to reduce the likelihood of ruptures and leaks.  If a saline implant breaks, the solution will be absorbed by the body; because saline implants are filled with a fluid that basically amounts to water and salt, there is little concern over such leaks.  The silicone filler in implants is also made from the naturally occurring element silicon.  Silicone is also used in cardiology, gastroenterology, dentistry, ophthalmology, and numerous other areas of medicine.  In the event of a leak, the silicone will enter the breast in the region surrounding the leak and lead to the development of scar tissue.  The result is often a change in the breast’s shape, a change in the breast’s firmness, lumps, and, possibly, pain. Not all women experience these symptoms. A ruptured saline implant will commonly result in deflation of the breast whereas a silicone leak can usually only be found through MRIs, ultrasounds, mammograms, or CT scans.