Breast augmentation is currently the most common cosmetic surgical procedure performed by plastic surgeons in the United States, with 290,000 cases performed in 2016 alone.1 Breast augmentation mammaplasty using silicone prostheses was first described in the 1960s.2 Since that time, breast implants have undergone significant changes in material properties, fill, and shape.2 , 3 Early prostheses were prone to frequent implant rupture4–7 and high rates of capsular contracture,8–10 a potentially painful or visibly distorting tightening of the implant capsule. To mitigate the risk of capsular contracture, texturing of the implant shell was developed in the 1980s based on the theory that an irregular shell surface would prevent the parallel alignment of collagen fibers and, by extension, prevent capsular contracture.10–12 Preliminary studies supported this theory with an observed reduction in capsular contracture rates,13–15 but recent implant studies have demonstrated negligible differences in contracture rates between textured and smooth styles, and the issue is now generally considered less certain.16–19
Texturing was later adopted as a necessary adjunct for form-stable anatomical implants, which have been available in Europe for decades but which were introduced to the U.S. market only 5 years ago.20 Because anatomical implants must remain positioned upright without rotating, texturing is considered a requirement to provide friction and reduce malposition.
Recent research has suggested a reproducible association between textured implants and the development of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL), a potentially fatal T-cell lymphoma. Although rare, the presence of a textured breast implant is thought to increase the risk of developing breast ALCL by an estimated 67 to 421 times,21 an estimated 7 percent of breast plastic surgeons have reported personally treating a patient with a history of BIA-ALCL,22 and 508 unique cases have been reported in 23 countries.23 Concerns for causing a malignancy in elective surgical patients have led the plastic surgery community to prioritize BIA-ALCL investigation, with numerous recent publications on the topic and the creation of a national registry.24–37 Since the first reported case in 1997,38 the number of patients with BIA-ALCL has been increasing rapidly, possibly as a result of more widespread adoption of textured implants or increased awareness and diagnosis. Over the past decade, the U.S. Food and Drug Administration has become progressively involved in tracking and investigating ALCL, and has released several national announcements, including a recent report publicly linking ALCL to textured implants. It is unclear how the speculated association between textured implants and the development of ALCL has impacted physician practices, specifically related to the use of textured implants.
Doren et al. evaluated trends in sales of textured implants,39 and our work adds to the body of literature by addressing actual use by board-certified plastic surgeons across all manufacturing entities. Thus, we proposed the use of data acquired from records submitted to the American Board of Plastic Surgery Maintenance of Certification Tracer Database to investigate recent trends in the use of textured implants for cosmetic augmentation. Specifically, we examine and describe the relationship between textured implant use and landmark events in ALCL discovery, implant approvals, and U.S. Food and Drug Administration announcements.
PATIENTS AND METHODS
The American Board of Plastic Surgery Maintenance of Certification Tracer Database includes all procedures performed, recorded, and submitted to the American Board of Plastic Surgery as part of maintenance of certification. To review, surgeons submit 10 consecutive cases from a given tracer case (in this case, augmentation mammaplasty) to the American Board of Plastic Surgery for review during years 3, 6, and 9 of a 10-year Maintenance of Certification cycle. This data set was queried for all cosmetic breast augmentation procedures performed between 2011 and 2015. The cases using textured breast implants were then identified and the proportion and absolute number of textured implant cases were determined for each year. In addition, patient demographic and preoperative variables were extracted, including age, sex, nipple-to–inframammary fold distance, notch-to-nipple distance, base width, implant composition, implant position, and incision. A nested logistic regression analysis with a surgeon random effect was used to account for the expected correlation among all same-surgeon cases. Indeed, most surgeons (85.1 percent) tended to use only smooth or only textured implants. Because we hypothesized an increase in textured implant use would strongly correlate with the introduction of form-stable implants, a new regression analysis including implant variables was generated to account for implant shape. Statistical significance was defined as p < 0.05. Release 9.4 of the SAS System (SAS Institute, Inc., Cary, N.C.) was used to perform the data analysis. The nested logistic analyses were fit by the NLMIXED procedure of this software.
A total of 11,716 cosmetic breast augmentation cases were identified from the Maintenance of Certification Tracer Database between 2011 and 2015. The vast majority of patients were women, as expected (99.6 percent), with a mean age of 34 ± 9.9 years. Silicone implants were the most common [7863 (66.7 percent)], followed by saline [2953 (25.1 percent)] and form-stable [212 (1.8 percent)], with the remainder being categorized as “other” (Table 1). Implant surface data were available for 11,618 (99.2 percent) of the reported cases, with 92.2 percent of cases using smooth implants and 6.9 percent of cases using textured implants during the study period (Table 1).
It was discovered that textured implant use increased steadily every year during the study period from 50 cases to 328 cases, or a proportion of 2.3 percent to 13.0 percent of all cases (Fig. 1).40 The Jonckheere’s trend test41 confirmed a statistical increase for each year and overall (p < 0.001). Because each surgeon tended to consistently use only one type of implant (85.1 percent of surgeons), a nested random effects logistic regression analysis was used to account for same-surgeon effects. There were 880 surgeons in the study period, and the proportion of surgeons who performed at least one case with smooth and one case with textured implants increased significantly over time (6.2 percent in 2011 to 24.3 percent in 2015), which was found to be significant by this nested analysis (p < 0.001). Similarly, the proportion of surgeons using only textured implants for their breast augmentation procedures increased significantly during the study period (0.4 percent in 2011 to 4.4 percent in 2015; p < 0.001). Because the largest increase in textured implant use occurred between 2012 and 2013 (2.75 percent to 6.85 percent), the 2 years that the major implant manufacturers initially received U.S. Food and Drug Administration approval for shaped implants,42 a new logistic analysis was created to control for the use of form-stable implants. Form-stable implants represented only 1.8 percent of all implants used during the study period and, even after controlling for form-stable implant emergence, the new nested-surgeon logistic analysis still yielded a significant increase in textured implant use over time.
The use of textured implants was then compared to other patient variables, again using a nested logistic analysis to control for same-surgeon effects. It was determined that textured implants were preferentially selected in older patients (11.5 percent for those aged 60 years or older versus 5.4 percent for those aged 0 to 30 years; p < 0.001). In addition, implants placed in the subglandular position were more likely to be textured (20.5 percent) compared to submuscular (8.4 percent) or dual-plane (7.8 percent) (p < 0.001 for both) implants. However, in this logistic analysis, the use of textured implants was not found to be significantly associated with notch-to-nipple distance, nipple-to–inframammary fold distance, or base width.
Some surgeons prefer textured breast implants out of a perception that these implants may be more stable, prevent implant malposition,43 and provide some protection against capsular contracture, particularly in the subglandular pocket,44 and surface texturing is at present required in shaped anatomical implants. However, recent reports have associated the use of textured implants with BIA-ALCL, a rare but potentially fatal malignancy.34 , 39 , 45 The first case of BIA-ALCL was described in 1997, almost four decades after the introduction of silicone breast prostheses. It is unclear whether ALCL has appeared in the past two decades only as a direct result of implant texturing developed in the 1980s. Since the first described case, the number of reported cases of ALCL has increased, likely as a result of increased awareness.
With these considerations in mind, it is important to understand the recent national trends in textured implant use. The Maintenance of Certification Tracer Database provides a reliable substitute for exploring practice patterns in the United States. Specifically, we demonstrate a robust increase in textured implant use by plastic surgeons for cosmetic augmentations between 2011 and 2015. Not only did we observe an increased use of textured implants by select surgeons, but throughout the study period, more plastic surgeons trended from exclusively smooth implant use to a practice intermixing both implant shells. Moreover, the proportion of surgeons using only textured implants in their practice increased. The association with texturing was first reported in an abstract by Brody et al. in 2010,46 followed by a complete article description in 2014.34 However, even after the article release, the use of textured implants continued to rise in our study the following year. This may reflect a reaction latency; however, this is unlikely given that, in January of 2017, 12.7 percent of the breast implant market was still textured, nearly identical to the 2015 rate observed in our study (Fig. 1).39 Rather, it appears that surgeons are generally unconcerned about the potential association between implant texturing and ALCL given the rarity of the disease.
In addition to the rising proportion and total number of textured implant cases each year, we identified years with considerably larger relative increases. Specifically, between 2012 and 2013, the use of textured implants more than doubled, from 2.75 percent to 6.85 percent of all cosmetic augmentations. These years correspond to the period when Sientra (Santa Barbara, Calif.) received U.S. Food and Drug Administration approval for their shaped, textured implants in 2012, followed by Allergan (Madison, N.J.) and Mentor (Irvine, Calif.) receiving initial approvals in 2013 (Fig. 1).42 We also note that early in the study period (2011), the rate of textured implant use is very low at only 2.3 percent despite this technology being available since the 1980s. After witnessing textured implants fall out of favor in the mid 2000s, it is reasonable to conclude that the recent increase in use was a direct result of the introduction of shaped implants. However, after controlling for the use of form-stable implants, the increase in use of textured implants over time remained significant during the study period. For example, form-stable implants represented only 4.9 percent (124 cases) of all augmentations in 2015, meaning that 204 of the textured implant cases in 2015 were textured round implants, four times the number of textured cases performed only 4 years prior in 2011.
We proceeded to use a nested surgeon logistic analysis to determine other significant associations that could be driving the observed increase in textured implant use. Importantly, subglandular augmentations were found to be significantly more likely to involve textured implants than dual-plane or submuscular augmentations. Although the data surrounding the ability of textured implants to reduce capsular contracture are inconsistent depending on the specific study, many surgeons believe that textured implants reduce capsular contracture most effectively in subglandular augmentations.44 The discovered association between subglandular placement and textured implants may therefore reflect a desire to reduce capsular contracture in subglandular cases. However, only 19.9 percent of all textured implant cases were placed in the subglandular pocket, so the recent increase in textured implants cannot be attributed entirely to this rationale. The remaining round textured implants placed submuscularly or dual-plane may have still been selected to reduce capsular contracture, although this would be speculative. It was also noted that textured implants were used more frequently in elderly patients. The motivating factors driving the significant increase in use of textured implants over the past several years remain unknown.
Although our results show a clear trend toward textured implants increasing in relative market share, there are certain limitations to our study. Our results suggest a growing preference for textured implants among board-eligible American Board of Plastic Surgery diplomates, but it cannot be necessarily assumed that this finding is generalizable to all practicing plastic surgeons. It may be the case that less experienced plastic surgeons have not established long-term preferences and may be more willing to experiment with newer implant technology. Regardless, it remains clear that at least within specific practitioner populations, the preference for textured implants is growing substantially in recent years despite evidence associating textured implants to ALCL.
Textured implants represent a growing proportion of the breast implants used for cosmetic augmentations by American Board of Plastic Surgery–certified plastic surgeons in the United States, despite mounting evidence linking textured implants to BIA-ALCL. This trend is relatively recent and may be motivated by perceptions of effect on capsular contracture rather than the introduction of form-stable implants. Plastic surgeons must weigh many variables and consider all the risks and benefits when selecting implants for each patient.
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