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Textured Breast Implants, Anaplastic Large-Cell Lymphoma, and Conflict of Interest

Swanson, Eric M.D.

Plastic and Reconstructive Surgery: February 2017 - Volume 139 - Issue 2 - p 558e–559e
doi: 10.1097/PRS.0000000000002966
Letters

Swanson Center, 11413 Ash Street, Leawood, Kan. 66211, eswanson@swansoncenter.com

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Sir:

Hu et al.1 conclude that bacterial infection leads to anaplastic large-cell lymphoma (ALCL) and insist that all surgeons implement their 14-point intraoperative plan2 to reduce the risk of infection (e.g., nipple shields, antibiotic irrigation). Adams2 considers an infectious cause an obvious fact, stating “there was no way it was caused simply by texture.”

The authors1 concede that there was no difference in the number of bacteria comparing capsule specimens from ALCL patients with nontumor specimens. The bacterial count was higher on the affected side, but the number of samples was very limited (n = 3). Textured implants are not just “overrepresented”1 in cases of ALCL. Brody et al.3 report no cases of ALCL in women treated solely with smooth implants. Seemingly at odds with his coauthors1 and discussant,2 Brody believes that texturing is the likely trigger, not infection.4

Adams5 comments that “a cosmetic implant patient is twice as likely to be struck by an asteroid as to develop implant-associated ALCL.” Only one person is known to have been struck by a meteorite.6 The U.S. Food and Drug Administration now has 258 medical device reports of ALCL.7 A recent survey found that 7 percent of plastic surgeons had seen a case of ALCL in their practice.8

In view of this serious risk, why are textured devices still being used? Texturing promotes tissue adherence to avoid implant malrotation.8 However, there is no evidence that shaped implants are superior to round implants for cosmetic breast augmentation; in fact, there is evidence to the contrary.8 Superiority over round devices has even been questioned for breast reconstruction.9 Adams2 considers antibiotic wound irrigation part of the standard today, but supportive controlled trials are lacking. Some studies report no benefit in reducing capsular contracture rates.10,11 It is even possible that antibiotics stimulate biofilm formation by creating a hostile environment for microbes.12

Patients are uninformed of the link between textured devices and ALCL. This strong, possibly universal3 association is still not mentioned in manufacturer brochures13 or the American Society of Plastic Surgeons consent forms.14 The reader would think that ALCL is a rare complication of any breast implant, not just textured implants. She should be informed of the added risk with texturing so she can participate in implant selection and possibly select a smooth device. Clemens et al.15 recommend including ALCL in the informed consent discussion. However, the possibility of ALCL developing with a smooth implant is so unlikely it falls below the threshold for foreseeable risk—the criterion for inclusion in the informed consent process.16

This discussion leads directly to conflict of interest. Most researchers receive financial support from breast implant manufacturers, including Hu et al.1 Adams5 previously reported financial conflicts with implant manufacturers. Textured, form-stable silicone gel implants are much more profitable for the manufacturer than smooth gel- and saline-filled implants. However, a transition to smooth, round devices would improve patient safety. We can be proactive. The industry can adapt, as it has in the past. The problem, and its resolution, could not be clearer.

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DISCLOSURE

The author declared no potential conflicts of interest with respect to the research, authorship, and publication of this communication. The author received no financial support for the research, authorship, and publication of this communication.

Eric Swanson, M.D.

Swanson Center

11413 Ash Street

Leawood, Kan. 66211

eswanson@swansoncenter.com

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REFERENCES

1. Hu H, Johani K, Almatroudi A, et al. Bacterial biofilm infection detected in breast implant-associated anaplastic large-cell lymphoma. Plast Reconstr Surg. 2016;137:1659–1669.
2. Adams WP Jr. Discussion: Bacterial biofilm infection detected in breast implant-associated anaplastic large-cell lymphoma. Plast Reconstr Surg. 2016;137:1670–1672.
3. Brody GS, Deapen D, Taylor CR, et al. Anaplastic large cell lymphoma occurring in women with breast implants: Analysis of 173 cases. Plast Reconstr Surg. 2015;135:695–705.
4. Brody GS. The case against biofilm as the primary initiator of breast implant-associated anaplastic large cell lymphoma. Plast Reconstr Surg. 2016;137:766e–767e.
5. Adams WP Jr. Discussion: Anaplastic large cell lymphoma occurring in women with breast implants: Analysis of 173 cases. Plast Reconstr Surg. 2015;135:709–712.
6. Nobel J. The true story of history’s only known meteorite victim. Available at: http://news.nationalgeographic.com/news/2013/02/130220-russia-meteorite-ann-hodges-science-space-hit. Accessed May 26, 2016.
7. U.S. Food and Drug Administration. Anaplastic large cell lymphoma (ALCL) in women with breast implants: Preliminary FDA findings and analyses. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm. Accessed May 26, 2016.
8. Hidalgo DA, Sinno S. Current trends and controversies in breast augmentation. Plast Reconstr Surg. 2016;137:1142–1150.
9. Gahm J, Edsander-Nord A, Jurell G, Wickman M. No differences in aesthetic outcome or patient satisfaction between anatomically shaped and round expandable implants in bilateral breast reconstructions: A randomized study. Plast Reconstr Surg. 2010;126:1419–1427.
10. Drinane JJ, Kortes MJ, Bergman RS, Folders BL. Evaluation of antibiotic irrigation versus saline irrigation in reducing the long-term incidence and severity of capsular contraction after primary augmentation mammoplasty. Ann Plast Surg. 2016;77:32–36.
11. Pfeiffer P, Jørgensen S, Kristiansen TB, Jørgensen A, Hölmich LR. Protective effect of topical antibiotics in breast augmentation. Plast Reconstr Surg. 2009;124:629–634.
12. Poppler L, Cohen J, Dolen UC, et al. Histologic, molecular, and clinical evaluation of explanted breast prostheses, capsules, and acellular dermal matrices for bacteria. Aesthet Surg J. 2015;35:653–668.
13. Mentor Corp. Patient educational brochure: Breast augmentation with Mentor MemoryGel Silicone Gel breast implants. 2013.Santa Barbara, Calif: Mentor Corp.
14. American Society of Plastic Surgeons. Informed consent: Augmentation mammaplasty with silicone gel-filled implants. 2012.Arlington Heights, Ill: American Society of Plastic Surgeons.
15. Clemens MW, Miranda RN, Butler CE. Breast implant informed consent should include the risk of anaplastic large cell lymphoma. Plast Reconstr Surg. 2016;137:1117–1122.
16. Office for Human Research Protections. Code of Federal Regulations. General requirements for informed consent. Available at: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.116. Accessed May 27, 2016.
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