Perception of Risk and the Choice Between Smooth and Textured Breast Implants

In their online survey, Wood et al1 conclude that respondents generally are willing to accept a higher risk of Breast Implant-Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL) in exchange for a reduced risk of capsular contracture and the option of a teardrop-shaped implant. The authors believe that this information “can help inform regulatory and care paradigms.” The authors' conclusion is an important one because it may influence patient and surgeon decision making. It may affect recommendations of the US Food and Drug Administration (FDA). Therefore, the premises for this comparison merit close consideration. The 10 authors include 6 PhD researchers, and 3 co-authors with master's degrees employed by a research institute (RTI International, Research Triangle Park, Durham, NC) or the FDA.1 The senior author, Michelle Tarver MD, is an ophthalmologist and an epidemiologist. She is the Director of the Center for Devices and Radiological Health at the FDA. She is responsible for overseeing the regulation of breast implants. This “threshold technique” study is reminiscent of a previous publication that used a “micromort analysis” to compare the risk of BIA-ALCL with common activities that pose risk, such as driving a car, concluding that the risk is comparatively small and an acceptable trade for the purported benefits of textured devices.2 The authors start with the premise that a textured implant “increases” the risk of BIA-ALCL. This assumption is flawed because it implies a continuum of risk; textured implants are further along this continuum than smooth devices. In fact, the difference in risk is categorical, not relative.3 Mathematically, the difference in risk is infinite because the risk for smooth implants is zero. By analogy, one would not say that the risk of pregnancy is increased in women.3 To do so, one would have to accept a risk of pregnancy in men. Remarkably, to date, there is no published case of BIA-ALCL arising in a woman known to have received only smooth breast implants.4 In 2021, the Scientific Committee on Health, Emerging and Environmental Risks (SCHEER) concluded that textured implants are not just associated with a greater risk of BIA-ALCL; textured devices are causative for this malignancy.5 A recent consensus conference convened by the American Association of Plastic Surgeons came to the same conclusion.4 There may be other factors, such as a genetic predisposition,4 but without textured implants, there would be no malignancy. Prospective patients and plastic surgeons could be forgiven for not appreciating the difference between relative and categorical risk. The FDA website cautions that BIA-ALCL “occurs more commonly in patients with textured implants than smooth implants.”6 The Allergan (an AbbVie company, North Chicago, IL) boxed warning and patient checklist reiterates, “this cancer occurs more commonly in patients with textured implants than smooth implants.”7 Patients are likely to believe that smooth implants carry a risk, but not as great as textured devices. This publication is unusual in that only 2 of the authors are physicians and only 1 co-author is a plastic surgeon.1 The lead author, who is also the corresponding author, is a research economist. Not surprisingly, the authors lack familiarity with this disease. For example, the authors searched for a publication providing an incidence rate for BIA-ALCL in patients with smooth implants, unaware that the incidence is zero.4 The authors reported 28 patients with smooth implants listed on the 2022 FDA website (since updated), without comprehending that these patients did not have a complete implant history or had a history of at least 1 textured implant.8 The term “teardrop-shaped” is a colloquial term used by laypersons. Plastic surgeons use the label “anatomical” or “shaped.”9–12 The short list of references includes only 4 plastic surgery publications. An important summary of current knowledge about BIA-ALCL was unreferenced.4 The first reference misconstrues the name of a well-known investigator (Santanelli Di Pompeo). Ironically, the authors conclude that their findings “underscore the importance of patient-physician communication around the benefits and risks of implant choices and shared decision-making.”1 An accurate understanding of the risk/benefit analysis is essential to such communication. BREAST APPEARANCE The authors present a graphic to their online subjects illustrating round implants for the smooth choice versus a teardrop option for the textured choice (Fig. 1).1 The smooth implant diagram depicting a round implant shows an unnatural semicircular “fake” look with an overly filled upper pole. By contrast, the teardrop image appears natural. Respondents would be expected to opt for the textured implant option. However, this representation is misleading. Although the upper pole may appear overly full immediately after surgery, round implants settle and adopt a more relaxed shape, unlike the illustration.FIGURE 1: The authors' threshold technique question. Reprinted from Wood et al.1Moreover, several studies,9–12 including a meta-analysis,12 reveal no aesthetic advantage for shaped implants. Friedman et al9 found a highly significant (P < 0.001) aesthetic advantage for round (not shaped) implants in “naturalness” and upper pole assessment. Plastic surgeons are frequently unable to identify the type of implant based on photographs.9–12 A correct identification rate of implant shape using pooled data was 52%.12 Hidalgo and Weinstein11 concluded that their level 1 randomized study “provides high-level evidence supporting no aesthetic superiority of anatomical over round implants. Given that anatomical implants have important and unique disadvantages, a lack of proven aesthetic superiority argues against their continued use in breast augmentation.” These studies were published before the 2019 FDA ban13 on macrotextured implants. Consequently, they do not also consider the BIA-ALCL risk. Shaped implants introduce a risk of malrotation,14 which is avoided using round devices. Van Slyke et al15 reported that shaped Allergan Biocell textured implants perform much worse (not better) than smooth implants. Problems include malposition, malrotation, seroma, rippling, rupture, pain, capsular contracture, double capsules, and the shortest time to explantation. Cordeiro,16 in his experience replacing Biocell implants with smooth, round devices in breast reconstruction patients, found that patients usually prefer their new smooth, round implants. CAPSULAR CONTRACTURE The second part of the authors' graphic illustrates a difference in capsular contracture risk (Fig. 1). The authors assign a 15% risk for smooth, round implants versus a 5% risk for textured devices.1 A widely cited meta-analysis reported no significant difference in capsular contracture rates when implants are placed subpectorally,17 the plane preferred by most surgeons. In 2020, Lista et al18 reported similar capsular contracture rates for smooth and textured implants in the subglandular plane (1.6% and 3.3%, P = 0.20). A large 2014 manufacturer core study of Allergan Natrelle silicone gel breast implants with 10-year follow-up reported a capsular contracture rate of 18.9% for breast augmentation, with no significant difference between textured and smooth devices.19 Very low rates of capsular contracture (1%) have been reported recently for breast augmentation patients treated with “nanotextured” implants.20 These implants are so lightly textured that they are considered equivalent to a smooth surface.3 Indeed, recent literature does not support a 3-fold increase in capsular contracture risk for smooth, round implants over textured devices. BIA-ALCL The third set of images compares the risk of BIA-ALCL between smooth implants and textured devices (Fig. 1). A risk of less than 0.1% is indicated for smooth implants. For textured implants, a BIA-ALCL risk of 3/1000 people is illustrated. The graphic appears almost empty. Respondents' reactions depend heavily on how the data are presented. If over 1264 dots were used instead to represent women affected globally with BIA-ALCL,8 versus 0 dots for all patients worldwide with smooth implants, the respondents might have a much different reaction. Participants are not informed that BIA-ALCL carries a 5% risk of death.8 If the right side of the graphic showed at least 63 dots representing fatalities8 compared with none on the left side, respondents might also have a much different reaction. If prospective patients are informed that one device carries a risk of serious illness and death and the other does not, and any advantages are equivocal, and may even favor smooth, round implants,15 few women, probably none, would be willing to take the risk. Patients are understandably intolerant of small risks that are completely avoidable.21 Moreover, respondents are not informed of a cost difference. Smooth, round implants are less expensive (and less profitable for the manufacturer) than textured, shaped devices. Respondent reluctance to take on additional risk is evidenced by a willingness to accept less than a 1% increase in BIA-ALCL risk to gain the alleged benefits in appearance of a shaped implant and a reduced capsular contracture rate.1 ETHICAL CONSIDERATIONS The rationale for this study is unclear. Why would the FDA sponsor such a study? What is the clinical relevance of knowing that women may choose a product that carries a small risk of lethality, based on incomplete (eg, mortality is not mentioned) information that inaccurately favors textured breast implants? This approach does not seem to align with the FDA's gatekeeper function to protect patients from unsafe devices. How do textured breast implants compare with other products that pose a small but potentially lethal risk?21,22 When Toyota Corporation was faced with accelerator pedals getting stuck, causing dozens of fatalities, it issued a recall (but also paid a massive fine for waiting too long).23 Automobile manufacturers do not charge customers for replacing defective parts, nor do they insist that the device malfunction before replacing it. Customers are relieved of the anxiety of driving with a pedal that could get stuck, and the manufacturer is relieved of exposure to liability if the defective part was not replaced and an accident ensued. The mechanical basis for the defective part is not relevant to the decision making.22 In the case of textured breast implants, manufacturers and their surrogates have taken a different approach. Patients are discouraged from having their existing textured devices replaced.24–26 Asymptomatic patients receive no financial assistance for surgery to replace the implants with safe smooth devices, although they receive smooth replacement implants at no charge.24 Patients only qualify for financial aid if they develop this malignancy. Allergan reimburses patients diagnosed with BIA-ALCL $7500 in return for a signed release of liability in favor of Allergan.27 Moral hazard is a consideration.26 Surgeons and the FDA do not have to bear the responsibility for their recommendations. They are not responsible for reimbursing patients for their medical costs incurred in treating BIA-ALCL, which can be several hundred thousand dollars.3,28 Each patient requires a PET-CT scan as part of their workup, explantation, capsulectomies, and possibly chemotherapy, immunotherapy, and radiation, depending on the stage of the disease.26 Patients are left traumatized physically, psychologically, and financially.28 Neither the implanting surgeon, the manufacturer, nor the FDA is responsible for reimbursing patient families (if that were possible) for the unnecessary loss of their loved one. It is sobering to consider that every patient death from BIA-ALCL could have been avoided if the patient had received a smooth device.28 Many plastic surgeons who have experienced this serious complication in one of their patients never insert another textured device.3 CONFLICT OF INTEREST At the 2019 FDA Hearing, plastic surgeons, many of whom were financially conflicted, unanimously testified in favor of keeping textured implants available.28 By contrast, every patient with BIA-ALCL who attended, some fighting for their lives, pleaded with the FDA to ban these harmful devices. The FDA panel initially ruled in favor of keeping macrotextured implants available before changing course and requesting their withdrawal from the US market a few months later, on July 24, 2019, after additional cases and patient deaths were reported.13 Allergan distributes millions of dollars to plastic surgeons, our societies, our meetings, and our journals.26 Although the authors report no conflicts of interest with implant manufacturers, all 10 are employed by the FDA or a research institute that received funding from the FDA.1 GOING FORWARD In the US, smooth breast implants and tissue expanders are now inserted almost exclusively.3,29 Asking patients to accept an unnecessary risk of a malignancy that carries heavy morbidity and a 5% risk of death is unethical. Undue financial influence has created a moral blind spot for plastic surgeons.26 Even today, some plastic surgeons are skeptical regarding causation, or believe the risk is negligible.3 In 2023, 9.7% of the breast implants sold in Italy were macrotextured.30 Some plastic surgeons look forward to vindication when a BIA-ALCL case is finally reported in a woman known only to have been exposed to smooth implants.31 Others believe the small risk is worth taking. One UK plastic surgeon compares the risk to riding a motorcycle instead of driving an automobile to his office.3 Although BIA-ALCL is being studied to discover how surface texture triggers this malignancy,4 this knowledge is not necessary to correctly manage patients.22 A recommendation to abandon textured devices is not new.32 Capsulectomies are not mandatory for asymptomatic patients with normal-appearing capsules.33 Importantly, plastic surgeons should not discourage women from having their textured implants replaced with smooth devices.26 Although any benefit in risk from textured implant removal or exchange is unknown, epidemiological clues suggest that replacement may be helpful, by decreasing the duration of exposure.4,34 Implant replacement can also bring patients peace of mind.4,26 Even if there were an advantage for textured, shaped devices, any marginal aesthetic benefit cannot possibly justify introducing a risk of serious illness and death to a cosmetic operation.3 The boxed warnings and the FDA website need to be updated to properly inform patients of the categorical difference in risk.3,29 The FDA should consider amending its 2019 statement that it “does not recommend removal for patients without symptoms due to potential risks.”13 The risk/benefit analysis has changed.3 It is clear today that the risk is greater than once thought, whereas the risk of explantation is negligible.25,26 Patients should not be misinformed that the risk of implant removal or exchange exceeds the risk of BIA-ALCL.25,26 This decision should be left to the properly informed patient and her plastic surgeon. An accurate understanding of the facts is essential to this discussion.