Misinformation Abounds

Though several months have passed since the FDA issued the final guidance for certain labeling recommendations for breast implants, greater safeguards are needed to ensure that individuals considering breast implants are adequately informed of the risk for BIA-ALCL, among other complications. Materials such as the ASPS brochure, which states, “Breast implants do not impair breast health. Careful review of scientific research conducted by independent groups such as the Institute of Medicine has found no proven link between breast implants and autoimmune or other systemic diseases,”3 are sources of disinformation that hinder patients’ ability to make informed choices.

“What exactly is ‘breast health’ anyway?” said Swanson. “The statement is a little too short and does not tell the whole story.”

Zuckerman described the ASPS brochure as “terribly” out of date. “The Institute of Medicine report is more than 20 years old, and there has been a great deal of research since then,” she said. 


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Although the FDA recalled textured implants and expanders manufactured by Allergan in 2019, other textured implants are still available, even though cases of BIA-ALCL have been reported in patients with textured implants from other manufacturers.11,12 These implants are less aggressively textured than the devices from Allergan, and like all textured implants, they cost more than smooth implants and have been marketed as superior because of their ability to reduce the risk of capsular contracture.13

“Once you start reducing the degree of texturing, you really wonder whether it’s doing you any good,” Swanson said.

Existing evidence indicates that textured implants are not in fact superior devices, but plastic surgeons still use them, albeit infrequently.14-17 Nevertheless, misleading information aimed at patients considering breast implants could influence their choice of implant, underscoring the importance of patient access to information regarding BIA-ALCL risk.

The ASPS Brochure: Current Status

When Cancer Therapy Advisor inquired about the content of the brochure, an ASPS representative agreed that the information was “outdated” and removed the brochure from sale on its website.

Enclosed in the ASPS brochure was a list of websites that included breastimplantsafety.org, which—despites its domain name—did not include any safety information about breast implants. Instead, the domain redirected users to a different domain, smartbeautyguide.com, the patient site for The Aesthetic Society, a professional organization for plastic surgeons. A representative for The Aesthetic Society told Cancer Therapy Advisor that breastimplantsafety.org was active until 2015, when it migrated to their patient site, Smart Beauty Guide.

“We have been developing and will launch our new Aesthetic Society website that will include a dedicated section for patient education,” the representative wrote in an email. Within days of being contacted by Cancer Therapy Advisor, The Aesthetic Society updated the breastimplantsafety.org domain name to direct users to an existing page that provides resources about breast implants, including information about BIA-ALCL and breast implant illness, a systemic condition characterized by a wide range of symptoms that is currently under FDA investigation.18

Disclosures: For Drs Swanson and Clemens, the only payments received from industry for 2019 (the most recent year available) were in the form of food and beverage. Note that although Dr Clemens ceased consulting in 2015, he received consulting payments in 2016 and 2017, according to ProPublica’s Dollars for Docs resource.19,20

References

  1. FDA issues final guidance for certain labeling recommendations for breast implants. FDA. September 28, 2020. Accessed January 28, 2021. https://www.fda.gov/news-events/press-announcements/fda-issues-final-guidance-certain-labeling-recommendations-breast-implants
  2. Breast implants – certain labeling recommendations to improve patient communication. FDA. Published September 29, 2020. Accessed January 28, 2021. https://www.fda.gov/media/131885/download
  3. Breast reconstruction. American Society of Plastic Surgeons. Published 2019. Accessed January 28, 2020.
  4. @ASPS Members. Twitter. Published September 1, 2020. Accessed January 29, 2021. https://twitter.com/ASPSMembers/status/1300908808420589568
  5. Ghione P, Vorstenbosch J, Cordeiro PG, et al. Clinical characteristics and follow-up post-surgery of women with BIA-ALCL operated at a single institution. Presented at: 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; December 2-8, 2020. Abstract 2080.
  6. Chao AH, Gangopadhyay N. Industry financial relationships in plastic surgery: analysis of the Sunshine Act Open Payments Database. Plast Reconstr Surg. 2016;138(2):341e-348e. doi:10.1097/PRS.0000000000002404
  7. Gray R, Tanna N, Kasabian AK. Conflict of interest at plastic surgery conferences: is it significant? Plast Reconstr Surg. 2019;144(2):308e-313e. doi:10.1097/PRS.0000000000005877
  8. Swanson E. Plastic surgeons defend textured breast implants at 2019 U.S. Food and Drug Administration hearing: Why it is time to reconsider. Plast Reconstr Surg Glob Open. 2019;30;7(8):e2410. doi:10.1097/GOX.0000000000002410
  9. Swanson E. Highlights from FDA hearing on breast implants and BIA-ALCL, March 25 and 26, 2019.  Published June 7, 2019. Accessed January 28, 2021. https://www.youtube.com/watch?v=oWgjh0INJyQ
  10. Mark W. Clemens. Dollars for Docs. Accessed January 28, 2021. https://projects.propublica.org/docdollars/doctors/pid/78775/year/2015.
  11.  Allergan recalls Natrelle Biocell textured breast implants due to risk of BIA-ALCL cancer. FDA.. Updated September 12, 2019. Accessed January 28, 2021. https://www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer
  12. Srinivasa DR, Miranda RN, Kaura A, et al. Global adverse event reports of breast implant-associated ALCL: An international review of 40 government authority databases. Plast Reconstr Surg. 2017;139(5):1029-1039. doi:10.1097/PRS.0000000000003233
  13. Barnsley GP, Sigurdson LJ, Barnsley SE. Textured surface breast implants in the prevention of capsular contracture among breast augmentation patients: A meta-analysis of randomized controlled trials. Plast Reconstr Surg. 2006;117(7):2182-2190. doi:10.1097/01.prs.0000218184.47372.d5
  14. Hall-Findlay EJ. Breast implant complication review: Double capsules and late seromas. Plast Reconstr Surg. 2011;127(1):56-66. doi:10.1097/PRS.0b013e3181fad34d
  15. Van Slyke AC, Carr M, Carr NJ. Not all breast implants are equal: A 13-year review of implant longevity and reasons for explantation. Plast Reconstr Surg. 2018;142(3):281e-289e. doi:10.1097/PRS.0000000000004678
  16. Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants. FDA. Published May 2, 2019. Accessed January 28, 2021. https://www.fda.gov/news-events/press-announcements/statement-fda-principal-deputy-commissioner-amy-abernethy-md-phd-and-jeff-shuren-md-jd-director-fdas
  17.  McCarthy CM, Loyo-Berríos N, Qureshi AA, Mullen E, Gordillo G, Pusic AL, et al. Patient registry and outcomes for breast implants and anaplastic large cell lymphoma etiology and epidemiology (PROFILE): initial report of findings, 2012-2018. Plast Reconstr Surg. 2019;143(3S):65S-73S. doi:10.1097/PRS.0000000000005571
  18. FDA updates analysis of medical device reports of breast implant illness and breast implant-associated lymphoma. FDA. August 20, 2020. Accessed January 28, 2021. https://www.fda.gov/news-events/press-announcements/fda-updates-analysis-medical-device-reports-breast-implant-illness-and-breast-implant-associated
  19. Mark W. Clemens. Dollars for Docs. Accessed January 28, 2021. https://projects.propublica.org/docdollars/doctors/pid/78775/year/2016
  20. Mark W. Clemens. Accessed January 28, 2021. https://projects.propublica.org/docdollars/doctors/pid/78775/year/2017