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It’s Time to Reassess Breast Implantation… and Explantation

As surgeons, we face a lack of definitive agreement on several emerging patient concerns. Open dialogue and patient education are essential.

Lisa B. Cassileth, MD, FACS

As a plastic surgeon whose practice is largely focused on revision of prior breast surgeries, I have seen increased interest in breast implant explantation. This increased interest is driven in large part by both a lack of good science-based education for patients and growth of misinformation, including peer-to-peer spread. The reality is that we, as surgeons, also face a lack of definitive agreement on several emerging patient concerns. Importantly, I continue to believe that silicone breast implants are generally safe and that patients receiving implants are at low risk for dangerous side effects. Nonetheless, surgeons must begin to address emerging concerns about implant safety and be prepared to respond to patients’ valid reasons for seeking explantation. Informed Consent Informed consent for silicone breast implants has long included discussion of the risk for implant rupture, movement, and development of deformities, such as capsular contracture. Most are manageable risks that have been known for many years. As the as yet unproven breast implant illness (BII) continues to gain prominence, there are calls to at least re-assess the informed consent. Some argue that patients with unrelated autoimmune illnesses could be wrongly associating their symptoms with breast implants. Although we lack reliable data, anecdotal reports abound from surgeons who see women recover from symptoms once their implants are removed. Though it is just one example, I often point to a woman who came to me from Spain. She indicated that she experienced a range of systems, most notably exhaustion, that would resolve with a course of penicillin and then re-emerge after a few weeks. She linked the symptoms to her breast implants and, concerned about the potential risks of continuous antibiotic use, sought me out for explantation. She has been symptom-free since the implants were removed. Of note, I cultured her implants and grew C. acnes (formerly P. acnes), which is known to produce numerous inflammatory mediators. We culture all explanted implants, and one-third of our patients have positive cultures and positive PCR. Perhaps this bacterial presence is benign. Perhaps some patients are susceptible to an inflammatory state induced by bacterially generated inflammatory mediators. We cannot make a determination yet, but I believe we should maintain an open mind. It may be reasonable to update informed consent for breast implant candidates to at least indicate there is a possibility that biofilms can live on the surface of implants, and we don’t know the potential effects at this moment. Another aspect of breast implant health is the identification of silicone in other locations in the body, even when implants have not ruptured. I recently removed an intact 410 implant from a patient who had had a recurrent cancer. A biopsy of her lymph node identified free silicone in the node. A cohesive silicone gel is not expected to leak, and we would not intuitively anticipate finding silicone outside of an unruptured implant. Yet, we do have evidence of spread of microscopic silicone outside of intact implants. We believe this spread is benign, and we predict hundreds of women may have such spread with no negative impact. Nonetheless, it may be reasonable to address this possibility with patients before surgery so that they can fully trust us as surgeons. The reality is that most patients who present for breast implant surgery are highly motivated and are unlikely to be dissuaded by updates to the informed consent, so why not be as thorough as possible? Natural Order There is a tendency, it seems, when we introduce any sort of aesthetic augmentation, for some individuals to tend toward an extreme. We have witnessed demand for large breast implants and are seeing a continuing interest in rather large, round buttocks. With time, the pendulum seems to eventually swing the other direction, as patients trend toward a more “natural” look with more subtle enhancement that eschews a “fake” or “inflated” appearance. (I predict patients will one day be looking at buttock reductions again!) Trends toward a more “natural” aesthetic appearance may reflect overall health trends. Currently, Americans show substantial interest in health and wellness, as we see a surge in “clean eating,” juicing, yoga, and meditation, etc. Such a natural focus may lead patients to reconsider the use of artificial materials, such as silicone, for body enhancement. The desire for more “natural” augmentation may also explain the increased demand for fat grafting as a method for breast augmentation. The “Mommy Makeover” patient is particularly well suited to fat grafting of the breast. Many women note a loss in breast fat and deflation of the breast after breastfeeding. They appreciate the ability to replace that lost volume with fat that is removed from elsewhere on the body, such as the love handles. Patients may perceive “natural” fat grafting as a “simpler” alternative to implants. Patients require education on the procedure, and surgeons must be well trained on the technique. Optimal aesthetic outcome and reduced risk for fat necrosis each depends on the placement of hundreds of tiny strips of fat throughout the breast. Whereas a surgical implant can take about 45 minutes to an hour, a fat grafting procedure will take a minimum of two hours for each hundred CCs, in my practice. Fat grafting has limitations. My standard is that you can double the size of a native breast. If a patient is an A, I can get them to small B. Once the graft is established, we can do a second fat grafting procedure for further augmentation, assuming there is a sufficient harvest site. Nonetheless, that A-cup patient will not get to a C or D in one surgery. Reasonable Reasons Controversies remain in the field of breast augmentation. Lacking solid scientific evidence, we should at least acknowledge that there is theoretical support for some emerging concerns. Additionally, we must be receptive to patients’ health preferences. We must be willing to listen to patients and talk to them about their concerns and share our knowledge in order to determine whether or not permanent explantation is appropriate. Some cases are straightforward; a woman in her 50s who had an initial implant 15 to 20 years ago may want an explantation with no new implant placed because she wishes to avoid yet another surgery in 15 to 20 years. This is reasonable. Decisions can become more complex, for example, for a patient who has had a mastectomy and will be left with a deformity if the implant is removed. Some patients who had rather large implants have very little natural breast tissue. The volume can’t possibly be replaced with fat. Such patients need to fully understand the consequences of the decision to explant and must understand what they’ll look like afterwards. 3D imaging has emerged as a useful tool to help patients visualize their post-explantation appearance, using the subtraction tool. When patients present for explantation, a few key considerations are essential. What is the patient’s rationale for seeking explantation? Is she being reactive? Does she need reassurance? If the patient has completely normal breasts, no capsular contracture, and is very implant dependent, then I explain that this decision will have major consequences for her that are going to make her feel deformed and be affected by the surgery in a negative way. Is explantation medically indicated? Does a capsule need to be removed? A medical basis for explantation makes the decision easier, although patients still require education about anticipated outcomes as well as options for repair/replacement of volume. What is the right surgery for repair? Must the silicone implant be replaced with fat grafting? Is a mastopexy in order? First, do the right surgery to deal with the implant, then determine how to provide a repair that is aesthetically appealing. Put somebody back together again, so that when they wake up every morning and put their bra on, and go work out, they feel good about themselves. Removal and restoration/repair go hand-in-hand, but each element deserves careful consideration. DON’T FORGET PECTORAL REPAIRS If you and the patient decide to pursue explantation, be sure to repair the pectoral muscle with subpectoral augmentation. If you do not, the patient will have window shading deformities or pec flex deformities. I benefit from surgeons’ failure to do these repairs, because patients come to me to fix the bad looking removals. Why not put the pectoral together like it anatomically was, prior to the implant? I suggest that you take the free edge of the pectoral muscle and sew it down where it used to lie. This simple step brings the whole breast together, looks good aesthetically, and it restores function and balance. Patients Not Cases As surgeons, we may tend to view “cases” from a clinical perspective. If a patient expresses concern about an implant absent any deformity/defect or symptoms that may be directly linked to the implant, a surgeon may assess the aesthetic of the breast and dismiss the patient’s concern. However, we should make an effort to focus on the patient, so as not to appear negative or patronizing. Listen to the patient. If you believe she is being reactive, then have an honest conversation based on facts and science. Explain what you perceive as her individual level of risk and leave open the possibility to revisit her concerns in the future. If the patient is adamant, consider providing the desired surgery, assuming there is no significant risk.

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Toward Racial and Ethnic Equality in Aesthetic Practice

Part one of a series begins a dialogue about challenges and opportunities in aesthetic medicine.

With Cheryl Burgess, MD; Jeanine B. Downie, MD; José Raul Montes, MD; Wendy W. Lee, MD; and Melissa Kanchanapoomi Levin, MD Do you see problems with regard to race/ethnicity? Jose Raul Montes, MD: Unquestionably, the problem exists since time immemorial, and it’s regrettable that we haven’t been able to overcome it. The problem is very complex and it cuts across geographical boundaries and cultures. I will share a personal perspective from my native Puerto Rico. You might find this surprising, but Puerto Ricans—who are considered as an ethnic minority—harbor feelings of prejudice amongst each other. Despite having a racial mix comprised of Native Taíno, European, and African blood, for purposes of the US Census an overwhelming majority classifies itself as “white.” Jeanine Downie, MD: I absolutely see many problems. Very significant problems. I believe we are caught in two pandemics currently: the pandemic of coronavirus and the pandemic of racism/police brutality. I will speak for African-Americans and say for 401 years we have been looking for equal justice under the law. Currently, we still do not have this. As everyone knows, this country was built on capitalism and we African-Americans were the country’s first capital. Our free labor enabled this country to become what it is today. Racism is a pandemic that continues to kill black and brown people mercilessly. Police officers seem to be unrelenting with their brutality as evidenced by the peaceful protests when protesters have been tear gassed, hit with rubber bullets, pushed over, and beaten. Wendy Lee, MD: I only rarely am on the receiving end of comments regarding my Asian heritage that could be taken as racist; these are more likely not meant to offend but perhaps based on experience, knowledge-base, or age of the person delivering the comment. Melissa Kanchanapoomi Levin, MD: This is a time of deep learning for everyone. There is so much to explore, unpack, learn, question, and evolve in our industry. I’m impressed that this moment of revelation for so many of us is different, but I’m not sure we are seeing the same type of movement in our field of aesthetic medicine and dermatology. As aesthetic physicians, while we do not stand on the front lines of the COVID epidemic, we, as physicians, are aware of the health disparities that disproportionately affect our Black American patients. The history of medicine, like the history of our country, is entrenched in racism and white supremacy. We often blame health care disparities on factors such as socioeconomic status, lack of access, poor medical or health literacy, or cultural mistrust in not only physicians but the overall institution of medicine. But we need to ask ourselves why there is a mistrust. We must face and learn about our history as American medical doctors, such as the 40-year Tuskegee syphilis experiment, where treatments for syphilis were purposely withheld, or when cells which were unknowingly donated from Henrietta Lacks, a black woman who passed away from cervical cancer, revolutionized medicine and science. In dermatology, we remain the second least diverse medical specialty, likely due to lack of mentorship, limited exposure to dermatology, implicit bias, and financial barriers. Was there a time that you faced a professional challenge as a result of your race/Ethnicity? How did you respond? Cheryl M. Burgess, MD: My colleagues or counterparts in research are often involved much earlier in their careers and are recruited more often for top innovative cosmetic research. My exposure and interest in dermatology began in research at NIH Dermatology under the tutelage of Dr. Gary Peck. At that time, the dermatology department was involved in Phase 3 Accutane clinical trials. My experience truly led me to pursue the specialty of dermatology, and I envisioned myself being involved in clinical research as well as a practicing dermatologist. Unfortunately, I did not start my clinical research career until 23 years later. In the mid-1990s, I spoke to those in industry and companies who were conducting Phase 3/4 clinical trials in cosmetic fillers and neuromodulators; however, I was passed over and ignored. I started reconstructing faces of AIDS patients who displayed HIV+ facial lipoatrophy with PLLA and published the first paper on the topic in the Journal of the American Academy of Dermatology. I testified before the FDA regarding the safety and efficacy of PLLA; however, my expertise and knowledge of PLLA wasn’t enough to impress those who selected the principle investigators for the PLLA cosmetic trials in the US. Not until the FDA imposed full representation of ethnicities and gender in clinical research trials according to the most recent census, was I ever considered to be a Principle Investigator. I have now gained the confidence of industry, and now I have the option to be selective to the clinical trials that I perform in my office. Whenever a clinical trial needs help in filling the protocol with subjects of skin of color, I will get a call. Dr. Montes: Admittedly, I have a built a professional career in a territory where Hispanic culture is prevalent. Hence, in Puerto Rico I’m not part of a so-called “minority,” and I haven’t encountered professional hurdles. However, I can share two observations from my interactions with stateside Americans: 1.) anyone who doesn’t fit the traditional WASP profile is automatically classified as a minority and treated differently; 2.) there is propensity to make unnecessary comments about non-native English speakers’ accents. Dr.Lee: Not that I can think of, fortunately. Dr. Downie: When I was a pediatric intern at NYH/Cornell, the program director, who was half African-American and half Jewish, could not stand me. For no reason, other than I was raised as an African-American with more money than she was raised with—and she felt that I was not “good enough” to be in the field of dermatology. She literally said this to me. Typically, interns have to do three weeks at Memorial Sloan Kettering Cancer Center, because dealing with all of those children with cancer is quite depressing. She made me do seven weeks. Following this, with regard to the neonatal intensive care unit (NICU), typically you don’t do more than four to five weeks, and she had me do 12 weeks. She claimed it was a “happenstance” of my schedule; it actually was that she was furious that I had the nerve to want to be going into dermatology. I responded by sucking it up, getting the work done, stressing out, and gaining about 45 pounds—because I became clinically depressed! Too many premature babies and children with cancer dying was too much for my heart to handle. She targeted me because I was black and did not know to “stay in my place.” This is one story among many for that program director…Another example of a professional challenge because of my race would be when I finished Mount Sinai as a chief resident. I interviewed widely, as did two colleagues in my year. The male, who was co-chief resident had about six offers, all for about $140,000. The female got about four offers, and hers were the equivalent of $125,000. Interestingly enough, I only got two job offers; one was at the same place that they were both offered $140,000 and $125,000, respectively. My offer was for$100,000. I responded by being livid, as I had published a few papers and had excellent references and credentials. I went to the head of that practice for an in-person second interview and asked if it was because I was black that I was offered so little. He denied this, stuttered, and became red in the face. I went on to work in Westfield, NJ for dermatologists who gave me a more fair offer. Was there a time you felt your profession or specialty supported positive change in regard to race? Dr. Lee: The American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) is very supportive of positive change and takes the fair and equal treatment of all very seriously. ASOPRS is committed to providing a welcome environment to all. We have a code of conduct policy that is expected of all who participate in our community and several committees that oversee appropriate behavior. Dr. Montes: After being asked to become a Trainer and a Speaker for major cosmetic industry players, I expressed my interest as a clinical trial investigator for new products. To my surprise, I always got the same negative response. While they recognized my experience, skills, demeanor, and resources, my coming from Puerto Rico was a limiting factor. Even clarifying that Puerto Rico falls under the same FDA regulations as any of the states wasn’t enough. The “being-outside-the-US impediment felt unreasonable and biased to me. Finally, they had their “aha moment.” Upon completion of our first clinical trial (which, by the way, was recognized for its excellence), invitations from the rest of the industry partners followed. Dr. Downie: I feel my specialty supported positive change with regard to race when the Skin of Color Center was started by Dr. Susan Taylor at St. Luke’s Roosevelt Hospital in New York City. The SOC center still focuses on the special and unique needs of skin of color patients and I personally feel/felt supported and validated by the very existence of this center. Additionally, the Skinclusion campaign by Obagi has been a mechanism for positive change within the pharmaceutical community. Obagi has always tested on all skin types for the past 30 years. As an African-American, I encourage all pharmaceutical companies to test on all skin types always. In addition, I strongly recommend that pharma hire all races and both sexes and promote some of these people up to the top tier of their companies so they can have real decision making power. Finally, I recommend forward-facing advertising with all races/ethnicities. I am honored to be a Skinclusion ambassador for 2020 and have worked closely with Obagi on this project. Next month, panelists address strategies for inclusion.