Commentary on: Is Banning Texturized Implants to
Prevent Breast Implant–Associated Anaplastic Large
Cell Lymphoma (BIA-ALCL) a Rational Decision?
A Meta-Analysis and Cost-Effectiveness Study
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Citation
Clemens, Mark W. and Christopher R. Knittel. "Commentary on: Is
Banning Texturized Implants to Prevent Breast Implant–Associated
Anaplastic Large Cell Lymphoma (BIA-ALCL) a Rational Decision?
A Meta-Analysis and Cost-Effectiveness Study." Aesthetic Surgery
Journal 40, 7 (March 2020): 732–734. © 2020 Oxford University Press
As Published
http://dx.doi.org/10.1093/asj/sjz374
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Oxford University Press (OUP)
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Author's final manuscript
Citable link
https://hdl.handle.net/1721.1/130165
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BREAST SURGERY
COMMENTARY
Commentary on: Is Banning Texturized Implants to Prevent Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) a Rational Decision? A Meta-Analysis and Cost-Effectiveness Study
Mark W. Clemens, MD, FACS
Dr Clemens is an Associate Professor, Department of Plastic Surgery, MD Anderson Cancer Center, Houston TX; and is Breast Surgery Section Co-editor for Aesthetic Surgery Journal.
Christopher R. Knittel, MIT
Dr Knittel is a Professor, Applied Economics, Sloan School of Management, Cambridge MA.
Corresponding Author: Dr Mark W. Clemens, Associate Professor, Department of Plastic Surgery, The University of Texas, MD Anderson Cancer Center, 1400 Pressler Street, Unit 1488, Houston, TX 77030, USA
E-mail: mwclemens@mdanderson.org; Twitter: @clemensmd
Disclosures: The author declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.
Funding: The author received no financial support for the research, authorship, and publication of this article.
“The doctrine of ‘social responsibility’ involves the acceptance of the socialist view that political mechanisms, not market mechanisms, are the appropriate way to determine the allocation of scarce resources…there is one and only one social responsibility of business- to use its resources and engage in activities designed to increase its profits” Milton Friedman1
The risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) elicits a strong visceral response among the media, patients, and many surgeons. Dr. Danilla and colleagues ask the reader to set emotions aside when considering BIA-ALCL, and to instead focus on a cost-effectiveness model of implant selection.2 The authors compare any complication
(infection, capsular contracture, reoperation, etc.3) to deaths from BIA-ALCL, and conclude that
the lost future productivity of a death in work-years is not cost-effective to justify switching to smooth implants. While most surgeons are unfamiliar with these models, the author’s approach to evaluate BIA-ALCL in microeconomic terms is a calculation undoubtedly performed by manufacturers and government authorities. But let us not stop there. If we are going to solely consider BIA-ALCL in economic terms, we need to dive deeper from the point of view of governments, manufacturers, and surgeons.
Governments have finite resources for health care expenditures and must allocate these funds judiciously based upon where the funds have the largest payoff. When a patient receives a breast implant, they (or an insurance company) bares the cost of between $800-1400 per implant placed. This cost is set by the manufacturer and passed on by the distributor (surgeon) with variable markup and considerable margin. In microeconomics, when one manufacturer’s product adversely affects consumers or another producer, and that impact is not accounted for in the price, this is known as a negative externality. Take for instance pollution, climate change, traffic congestion, or antibiotic resistance, each of these adverse sequelae come from products, but their actual cost is born not by the manufacturer or a distributor, but by society. For the patient that develops BIA-ALCL, the implant cost starts at $800 but inherently also includes fees from lab diagnosis and all subsequent therapeutics. Most recent estimates demonstrate that for BIA-ALCL patients, 58.6% will receive systemic chemotherapy, 44.8% radiation therapy, and 6.9% stem cell transplant.4 For the one in eight patients with lymph node metastasis, a single dose of
rounds on average. Lost wages are common, stretching from months to years in some patients, which must be factored into the cost model. At the March 2019 FDA Breast Implant Advisory Panel, one patient with Stage IIA disease requiring surgery alone (no additional treatment) reported her BIA-ALCL medical costs to be $207,000.5 Therefore, the personal cost of this
patient’s implant is greater than $200,000, and this financial burden is shouldered by the patient, insurance companies, and society.
Government authorities will often take action against negative externalities. However, they do not necessarily ban the product, as this would be considered a restriction on the free market, or limiting a patient’s right to choose a particular implant. Consider that society would be better off if everyone drove electric cars, but not everyone wants to drive electric cars. The government can institute Cap and Trade to cap CO2 emissions while allowing companies to
trade greenhouse gas emissions credits. A similar approach to this operates in California where
automobile manufacturers are required to have a certain share of their sales be EVs. Those that sell less than this share must buy credit from manufacturers selling larger than the requirement. Under this policy, for every Model S sale, Tesla can sell emission credits to essentially offset other traditional combustion companies.6
In applying this concept of cap and trade to BIA-ALCL, a breast implant company could be mandated to limit their textured implant production to a set percentage of their overall sales. A textured implant company could then pool sales, or buy “BIA-ALCL credits” from a smooth implant company if they wish to persist marketing the devices. Tesla has sold nearly $2 billion in compliance credits to traditional manufacturers such as Fiat and GM since 2010. That means that the sale of any large SUV ultimately subsidizes R&D technology development, if not outright pays for a Tesla Model 3. Governments may also apply Pigouvian taxes, a tax on the good that creates the negative externality such as a carbon tax for CO2 emission. In the Netherlands, a 25
euro breast implant surcharge completely funds the national breast implant registry.
Now consider the possibility of a “textured tariff.” In this situation, simply take all of the BIA-ALCL cases, multiply by the financial costs incurred per case ($200,000+ per patient), then divide by the total number of textured implants sold, and apply that surcharge amount each time a textured implant is placed. Revenue from tariffs can be reinvested into medical costs for uninsured patients, ALCL study grants, or research to produce alternative technology surfaces that have low capsular contracture while not being carcinogenic. Applying the tariff cost upfront
will drive down the demand curve with fewer BIA-ALCL cases due to less textured implants placed. This importantly preserves a patient’s choice to a textured implant - those textured customers with a high willingness to pay no matter what the cost, what economists refer to as the inframarginal zone.
How should manufacturers consider the cost-effectiveness of continued sales of textured breast implants? There is a sizable textured implant market, which accounts for half of the $1.5 billion world breast implant sales, that now faces a competition void formed by Allergan Corporation’s worldwide recall of their textured implants on July 23, 2019. However, due to the recognition that textured implants increase malignancy risk, US sales have been diminishing from 12% to 5% over the past two years and are expected to continue to decline.7 Manufacturers
must consider the opportunity costs of allocating resources, factory and warehouse space to textured devices with declining demand and revenue share. Anchoring a future business strategy to traditional macrotextured implants is an increasingly futile endeavor that only throws good
money after bad. Short term windfalls generated by scavenging a narrowing market must be
weighed against long-term losses in brand value, litigation, and poor patient perception. For surgeons, cost-effectiveness models assigning value on lost-life increments may be viewed by some as a callous endeavor to reframe an iatrogenic malignancy. We should not attempt to retroactively justify poor decisions. Despite fervent debate at national meetings, there are no existing randomized controlled trials of modern smooth versus textured implants in the last twenty years. Therefore, any claims of outcome superiority are speculative and unvalidated. When choosing what is right for our patients, we cannot rely on flawed economic or statistical modelling. The human cost is too high. BIA-ALCL patients have many tragic experiences that include delayed recognition, misdiagnoses leading to wrong disabling treatment, significant out of pocket costs, lost wages, invasive and systemic regimens, and significant tolls on family members. It is imperative that we remember that breast implants are always an elective
procedure for any indication. Manufacturers are responsible to shareholders, governments to
society at large, but only physicians bear the direct responsibility of advocacy and trust for our patients.
REFERENCES
Commented [CK1]: Love it! You have your next license
1. Friedman M. The social responsibility of business is to increase its profits. The New York
Times Magazine. September 13, 1970.
2. Danilla SV, Jara RP, Miranda F, et al. Is banning texturized implants to prevent breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) a rational decision? A meta-analysis and cost-effectiveness study. Aesthet Surg J. 2019. pii: sjz343. doi:
10.1093/asj/sjz343. [Epub ahead of print]
3. Coroneos CJ, Selber JC, Offodile AC 2nd, Butler CE, Clemens MW. US FDA breast implant postapproval studies: long-term outcomes in 99,993 patients. Ann Surg. 2019;269(1):30-36. 4. Clemens MW, Medeiros LJ, Butler CE, et al. Complete surgical excision is essential for the
management of patients with breast implant-associated anaplastic large cell lymphoma. J
Clin Oncol. 2016;34(2):160-8.
5. Holrah R. Presentation to the US FDA Breast Implant Safety Advisory Committee Panel. Bethesda, MD. March 2019.
6. Geuss M. Tesla sold greenhouse gas credits to Fiat and… GM? | Ars Technica.
https://arstechnica.com/cars/2019/06/tesla-sold-greenhouse-gas-credits-to-fiat-and-gm. Accessed June 3, 2019.
7. Tandon VJ, DeLong MR, Ballard TN, et al. Evolving trends in textured implant use for cosmetic augmentation in the United States. Plast Reconstr Surg. 2018;142(6):1456-1461.
