The Food and Drug Administration Bans Biocell Textured Breast Implants

On July 24, 2019, the US Food and Drug Administration (FDA) requested the immediate withdrawal of Biocell breast implants and tissue expanders from the marketplace.1 Allergan (Allergan plc, Dublin, Ireland) issued a global recall of the devices.2 In making its decision, the FDA cited 33 fatalities from breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) worldwide, a jump from 19 deaths known at the time of the FDA hearing held just 4 months previously.3 This surprising decision came less than 3 months after a decision by the FDA that Biocell implants could remain on the market and that the evidence did not justify a ban.4 The FDA ban on textured implants was preceded by regulatory actions in Europe, Canada, Brazil, and Australia.3 In its earlier May 2, 2019 ruling, the FDA noted (incorrectly) that BIA-ALCL occurred in women with smooth implants and that less than 5% of breast implants sold in the United States were of the macrotextured type anyway.4 Ethically, the market share of textured implants should be irrelevant.3 After learning of the ban, breast implant manufacturers and plastic surgery societies issued e-mails to plastic surgeons highlighting the message that the FDA does not recommend the removal or replacement of textured breast implants or textured tissue expanders in asymptomatic patients.5,6 A sample letter for patients capitalizes the word NOT, as in the FDA does “NOT” recommend removal.7 Another template for plastic surgeons to distribute to patients includes frequently asked questions about BIA-ALCL. In response to the question, “Is the FDA asking me to have my implants removed?” the answer is “No, just the opposite.”8 An e-mail to plastic surgeons from Allergan, defending its policy not to provide surgical fee assistance to women requesting implant replacement, includes the sentence, “This decision is in line with the FDA's recommendation not to remove textured implants” in asymptomatic patients. This sentence is slightly different from the actual FDA recommendation, which states that the FDA does not recommend that asymptomatic women have their textured implants removed (but does not recommend that women keep them either). It does seem contradictory to ban the devices and also suggest that they are safe to remain in women's bodies. An analogy would be an automobile manufacturer acknowledging that its vehicles have a problem with, for example, a sticking accelerator pedal, and will use a different design going forward, but there is no need for owners to have the defective part replaced. Indeed, any decision regarding implant removal or replacement is properly made by women who have the implants. Our duty is to inform them of their options and facilitate their choice and, yes, that means a financial commitment on the part of manufacturers and implanting surgeons. A model for a proper response is provided by Roberts et al,9 who sent letters to 264 women with textured breast implants and either replaced or removed the implants in 9 women (3.4%). Patient charges were discounted and surgeon's fees were often waived.9 A large prospective study by McGuire et al10 suggests a lifetime BIA-ALCL risk of approximately 1:2200 (after inclusion of 4 cases diagnosed after publication3) and possibly 1:1000, because the diagnosis is typically made 8 to 10 years after implantation and the mean follow-up time has not yet reached this mean interval.11 Cordeiro12 implanted Biocell implants in 3537 women undergoing breast reconstruction at Memorial Sloan-Kettering Cancer Center; 11 women were diagnosed with BIA-ALCL (1:322). The decision to abandon Biocell implants was not made by the implant manufacturers or plastic surgery societies. It was not driven by actual or threatened legal recourse because of the legal principle of preemption.3 At the FDA hearing, none of the 40 plastic surgeons testifying before the FDA, including 24 female plastic surgeons, recommended a ban on textured implants.13,14 However, Dr. Chevray, a nonvoting panelist and plastic surgeon, did make this bold conclusion at the very end of the hearing, to applause from the audience.14 His opinion was not reflected in the May 2, 2019, FDA statement.4 This important decision by the FDA to ban macrotextured implants rejected the mainstream opinion, reflected in numerous plastic surgery panel discussions, journal articles, and “best practices” recommendations to keep these implants available.3 The issue has been framed as one of patient choice.3,13,14 Despite the abundance of literature on this topic, relatively few dissenting opinions have been published.3,11,15–19 Only one plastic surgery journal editor recommended abandonment of textured implants.19 Of course, this is not the first breast implant crisis. In 1992, the FDA ordered a moratorium on the sale of silicone gel implants, which was finally lifted in 2006. Several large studies showed that silicone gel implants did not cause cancer or serious systemic illnesses.20–23 In retrospect, there was a great deal of “smoke,” but little “fire” in 1992. The present textured implant crisis is different. According to the FDA, there are at least 573 cases of BIA-ALCL worldwide and 33 fatalities.1 There is certainly a fire, but where is the smoke? At the 2019 FDA hearing, plastic surgeons and manufacturers repeatedly assured the public that patient safety was their priority.13,14,24 However, these assurances rang hollow to many women who attended the hearing, some of whom were still battling for their lives in the face of a life-changing disease.3 Their testimony is sobering.13,14,24 An edited, 27-minute “highlights video,”24 condensing 18 hours of presentations,13,14 is recommended viewing for any plastic surgeon who inserts breast implants. Brody et al,25 in their seminal 2015 article, informed plastic surgeons that the BIA-ALCL risk was exclusively linked to textured implants. Unfortunately, this critical message was clouded by subsequent reports that up to 30 women with smooth implants were also affected.13,24 Adams,26 in his discussion of the article by Brody et al,25 claimed that “there are clearly patients diagnosed with implant-associated ALCL who have had only smooth implants. That is the major flaw with the texture-only theory.” In 2017, the FDA published 28 adverse event reports of BIA-ALCL in women with smooth implants.27 These reports, however, were unreliable.27 Clemens, in his FDA testimony,13,24 emphasized that “no smooth-only implant cases have been reported in any case report or case series to date.” Regarding 30 cases reported24 on the FDA Web site, the cases “either had a mixed clinical history or no clinical history available for review.”13,24 The initial FDA ruling4 overlooked this important information. In retrospect, this disease should have been labeled “textured breast implant–associated anaplastic large-cell lymphoma.” In 2017, Sieber and Adams28 suggested that the risk of BIA-ALCL is trivial compared with other activities, such as driving a car, which also poses a risk of death. A “micromort” calculation may make plastic surgeons seem insensitive to the impact on individuals and families affected by this cancer.11 A diagnosis of BIA-ALCL creates substantial morbidity even if the disease is seldom fatal.3 Affected women complain that they are dismissed as a “statistical anomaly.”3,13,24 Reimbursement of US $7500 and free smooth replacement implants are of little help to women who are often financially devastated by the diagnosis and treatment.3,13,24 The FDA action does not affect less aggressively textured implants, which have a risk of BIA-ALCL approximately 6 times lower than the Biocell salt-loss implants, according to the FDA release.1 This distinction may be lost on patients. Even a smaller risk is best avoided without a very clear compensatory benefit. There is no reliable evidence that texturing limits implant movement or rotation in the first place. In their ultrasound study, Sieber et al29 found that both Biocell and Mentor (Irvine, Calif) Contour Profile Gel implants rotate in their pockets. Reliable evidence supporting aesthetic advantages of anatomical implants is lacking. A recent meta-analysis that included one randomized study30 and 4 observational studies concluded that there was no aesthetic advantage for anatomical implants.31 Van Slyke et al32 reported that Biocell breast implants perform not only no better than other implants but also spectacularly worse. Ironically, some surgeons are concerned that losing textured implants as an option might lead to more complications.3,13,24 However, many surgeons have adopted smooth implants exclusively for both cosmetic and reconstructive use without reports of increased complication rates or inferior outcomes.3 Ethical questions must be addressed. Why did plastic surgeons and our societies not act quickly to curtail a serious health risk? The answer, conflict of interest, is clear, but makes many plastic surgeons uncomfortable because of their financial links to industry. Plastic surgeons are reluctant to criticize implants if they have received “consultant” fees. Legally, these payments may be considered kickbacks and have created serious legal difficulties for physicians.33 A committee formed by the Institute of Medicine recommends restricting consultantships to the provision of objective technical advice paid at fair market value.34 Speakers at plastic surgery meetings are often heavily compensated by industry. Allergan is the top contributor, paying US $4,973,340 to 46% of the speakers at the 2017 meeting of the American Society for Aesthetic Plastic Surgery and US $1,598,901 to 34% of the speakers at the 2017 meeting of the American Society of Plastic Surgeons.35 At the 2018 meeting of the American Society for Aesthetic Plastic Surgery, none of the panelists called for abandoning textured devices.36 Two recent journal supplements dedicated to BIA-ALCL were funded by breast implant manufacturers.37,38 Neither included a recommendation to abandon textured implants. Corporate-funded publications invariably support the marketing goals of the sponsors.33 A counterpoint discussion is rarely provided. Collaboration is promoted over controversy.37,38 In her book, “In Defense of Troublemakers, The Power of Dissent in Life and Business,” Nemeth39 makes the case for dissenters. When dissenters are ignored, the consequences can be disastrous, such as the recent Boeing MAX plane crash.3 A difference of opinion should be welcome in corporate boardrooms, on plastic surgery panels, and in scientific publications. Remarkably, dissenting opinions bring groups far closer to the truth, even if the dissenting opinion turns out to be wrong.39 An insidious effect of consensus is that it shapes the way we think. We start to view the world from the majority perspective. Dissent broadens our thinking.39 Younger plastic surgeons may not be aware that our specialty was not always so heavily entangled with industry. A blurring of science and marketing has gone on for so long that it may be difficult to conceive an arms-length relationship.33 Let us imagine a new paradigm. Breast implant manufacturers save millions of dollars by not funding plastic surgery societies and surgeons. Less expensive smooth round implants are marketed instead of the more expensive shaped implants. The cost to women drops substantially. Plastic surgeons pay more to attend meetings but pay less for implants. The net financial effect is zero, and the benefit is a return of credibility.33 Relinquishing corporate funding is also the morally correct decision. The Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE) registry is available for reporting cases of BIA-ALCL.4 The case for a new registry, the National Breast Implant Registry to also study “breast implant illness,” was made at the FDA hearing.4,13,14,24 Several panelists raised concerns.13,24 Chief among them was where is the control group? Dr. Lippman, a panelist and Professor of Oncology and Medicine at Georgetown University, cautioned, “Many of these diseases and symptoms are extremely common…. When an extremely common thing [breast augmentation], being done 300,000 times a year, collides with something else that is common, attribution, just because it happened to a person, however sorry I am for that, doesn't prove the connection.” He continued, “I'm very concerned that you might create a tremendous database, accumulate hundreds of data points about these patients, and then not know quite what to compare it to, and that would be a catastrophe I think.”13,24 Such a massive data collection effort creates a huge time commitment.13,24 Patient confidentiality precludes doing a “deep dive” into subgroups for additional analysis. Who is paying? If the breast implant manufacturers fund this program, the cost is passed on to women in the form of increased implant prices. We need to consider any decision regarding a new registry carefully before acting on an “it makes sense” basis. Texturing also seemed to make sense. As reported by his successors,40 Goldwyn was extremely concerned about the pernicious effect of corporate influence on our specialty when he stepped down as editor of Plastic and Reconstructive Surgery in 2004. The textured implant crisis is, unfortunately, a clear example of his prescience. Let us work to be sure the textured breast implant crisis has a silver lining—an opportunity for learning, greater tolerance for dissenting opinions, and a catalyst to disengage our specialty from undue corporate influence.

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