The Influence of BIA-ALCL on the Use of Textured Breast Implant and its Placement: A Survey of Dutch Plastic Surgeons

Abstract

Background

Breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) and its association with macrotextured breast implants may have induced plastic surgeons to change their breast augmentation and breast reconstruction practice.

Objectives

The aim of this study was to survey Dutch plastic surgeons about the effects of BIA-ALCL on their choice of breast implant texture and placement technique.

Methods

An online questionnaire was distributed to all members of the Dutch Association of Plastic Surgeons. Descriptive data were presented as frequencies and percentages. Technique alterations were analyzed by the marginal homogeneity test for paired nominal data.

Results

A total of 63 plastic surgeons completed the questionnaire. The majority of respondents altered their use of textured implants due to BIA-ALCL concerns for both breast augmentation and reconstruction (75.4% and 69.8%, respectively; both being statistically significant, P < .001). Microtextured and smooth/nanotextured breast implants are now most frequently used. BIA-ALCL did not influence the placement technique in breast augmentation and reconstruction (87.7% and 94.3%, respectively). Dual-plane breast implant placement is still the most favored technique for breast augmentation, and submuscular placement is still most favored for breast reconstruction.

Conclusions

BIA-ALCL has had a significant impact on the use of macrotextured breast implants by Dutch plastic surgeons in both aesthetic and reconstructive breast surgery. Breast implant placement technique has not been affected.

Level of Evidence: 4

See the Commentary on this article here.

Around 35,000 breast implants are placed in the Netherlands annually and it is estimated that 3.3% of women have breast implants.^1,2 Numerous studies have proven that breast implants can improve self-esteem and quality of life. However, increasing attention on breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL), breast implant illness, and the polyimplant prothesis scandal has damaged the reputation of breast implants in the public eye. As of April 2022, 1130 unique cases of BIA-ALCL have been identified worldwide according the US FDA.³ The Dutch Ministry of Health has reported 70 cases up to 2020.⁴ The Netherlands has introduced nationwide databases such as the Nationwide Network and Registry of Histo- and Cytopathology in the Netherlands and the Dutch Breast Implant Registry, and has been among the countries reporting the most cases of BIA-ALCL. At least 3 patients from the Netherlands are known to have died from BIA-ALCL.⁵ The pathogenesis of BIA-ALCL is thought to be linked to a combination of breast implant texture, biofilm formation due to bacterial contamination, and individual genetic predisposition.⁶ In 2018, the Dutch government issued a ban on Allergan’s macrotextured Biocell breast implants (Allergan Inc.; Irvine, CA).⁴ Consequently, some plastic surgeons had to change their breast augmentation and breast reconstruction practice. We surveyed Dutch plastic surgeons about the impact of BIA-ALCL on their choice of breast implant texture and placement technique.

METHODS

An anonymous online questionnaire was distributed by the Dutch Association of Plastic Surgeons (NVPC) among its members by e-mail on January 10, 2022. The questionnaire was constructed with Google Forms (Google LLC; Mountain View, CA) and was closed for responses after 2 months.

The self-made questionnaire started with several demographic questions (eg, gender, years of experience, institution type, procedure type, number of procedures per year). Participants were then asked for their personal preferences about breast implant placement technique in breast augmentation and/or reconstruction, and implant texturing in breast augmentation and/or reconstruction, depending on which procedures the participant performed. Multiple-choice questions were asked on implant placement and texturing (see Appendix, available online at www.aestheticsurgeryjournal.com).

Four types of implant texture were identified: smooth/nanotextured (Sa < 10 μm), microtextured (Sa = 10–50 μm), macrotextured (Sa > 50 μm), and coated breast implants. Texturing was classified according to the International Organization for Standardization (ISO) 2018 classification based on arithmetic roughness (Sa) measured by scanning electron microscopy.⁷ Nanotextured breast implants are categorized as smooth in this study according to Barr et al.⁸ Coated breast implants were classified as a separate identity: another material (nonsilicon, namely polyurethane) is coated on a smooth or microtextured silicone implant and through that process becomes macrotextured. The polyurethane will gradually disintegrate and dissolve over time.

The patient information in this study was collected by the authors and deidentified. The study was approved by the medical ethics commission of the University Medical Center Groningen.

Statistical Analysis

Descriptive data were presented as frequencies and percentages. Technique alterations were analyzed by the marginal homogeneity test for paired nominal data. SPSS Statistics v. 24.0 (IBM Corporation; Armonk, NY) was used for all statistical analyses. P < .05 was deemed significant.

RESULTS

A total of 63 plastic surgeons filled out the questionnaire, a 21.7% response rate. Sex distribution was equal with 50.8% being male. Most plastic surgeons performed both breast augmentations and reconstructions (74.6%). See Table 1 for further demographic information.

Texturing

The majority of respondents changed their use of textured implants due to BIA-ALCL for both breast augmentation and reconstruction (75.4% and 69.8%, respectively; both being statistically significant, P < .001). In breast augmentation, macrotextured was the most commonly preferred implant prior to worldwide familiarity with BIA-ALCL (43.9%). Currently, macrotextured breast implants are no longer used, having been supplanted by microtextured and smooth/nanotextured implants (54.4% vs 38.6%, respectively). Of the respondents who used macrotextured breast implants, the majority switched to microtextured and smooth/nanotextured implants (60.0% and 40.0%, respectively). Interestingly, 27.3% of respondents who used microtextured implants for breast augmentation also switched to smooth/nanotextured implants.

The same trend was observed among the respondents performing breast reconstruction, where almost half of the respondents preferred macrotextured implants (49.1%) before worldwide familiarity with BIA-ALCL. Currently, microtextured (67.9%) and smooth/nanotextured (20.8%) implants are most popular in breast reconstruction.

Placement

BIA-ALCL did not influence placement technique in breast augmentation and reconstruction (87.7% and 94.3%, respectively). In breast augmentation, dual-plane placement is still mainly preferred as it was prior to BIA-ALCL (66.6%, and 68.4% respectively). Respondents also believed that this type of implant location results in superior aesthetic outcomes (66.6%). In breast reconstruction, most respondents preferred submuscular placement prior to BIA-ALCL as well as currently (66.0% and 56.6%, respectively). A minority of the respondents believed that submuscular placement also results in superior aesthetic outcomes (43.4%).

DISCUSSION

Rigorous measures have been undertaken since the discovery of BIA-ALCL to minimize the risk of developing this rare disease. The association of implant surface texturing and BIA-ALCL has generated some form of taboo surrounding these once-favored breast implants. We believe that it is essential to stay up-to-date with current surgical standards and preferences. Therefore, we surveyed Dutch plastic surgeons on the utilization of textured breast implants and preferred placement technique and the effect BIA-ALCL had on previous practices. Our data confirm that Dutch plastic surgeons have stopped using macrotextured breast implants and have made a significant shift towards microtextured and smooth/nanotextured breast implants. However, BIA-ALCL did not influence the plane in which implants are placed.

The Netherlands has one of the highest numbers of BIA-ALCL diagnoses in Europe.⁵ This is most likely due to the country’s modern healthcare system, a swift response to surging cases worldwide, and registration in our recently established nationwide databases. Dutch women with breast implants have a 1:35,000 chance of developing BIA-ALCL before they reach the age of 50 years and 1:7000 by the age of 75.¹ However, it may be more common than previously believed as recent studies from the United States reported a 1:355 to 1:559 incidence of BIA-ALCL after breast reconstruction.^9,10 Concerned patients with breast implants can check on implantaatcheck.nl whether there is an issue with the device. Although most cases of BIA-ALCL in the Netherlands concern macrotextured Biocell breast implants, patients are not recommended to have these preventively explanted as the risk of developing lymphoma is small and outweighed by the risk of regular surgical complications.⁴ In the case of BIA-ALCL, the NVPC management guidelines recommend explantation of the affected breast implant(s) and total capsulectomy as well as multidisciplinary consultation with a hematologist/oncologist to assess the need for chemotherapy, radiotherapy, and/or stem cell therapy.¹¹

Textured breast implants were introduced in 1968 to reduce capsular contracture rates following the first-generation smooth breast implants.¹² Capsular contracture is the most common complication and reason for reoperation after breast augmentation.¹³ A meta-analysis of 7 randomized controlled trials found that textured breast implants offer a 5 times higher protection against capsular contracture vs smooth breast implants.¹⁴ The authors, however, argued that the most important factor preventing capsular contracture is the plane in which the breast implants are placed, namely, submuscular (subpectoral or dual-plane).¹⁵ This is already the case in our cohort. It is important to note that several factors other than texture have been associated with the development of capsular contracture, namely, placement, the use of iodine rinsing, and biofilm formation.¹⁴

Biofilm formation following bacterial contamination has, in fact, also been suggested to play a key role in the development of BIA-ALCL. Breast implants with textured surfaces have been shown to support higher bacterial loads.¹⁶ Research suggested that biofilm formation on the implant surface may trigger chronic inflammation and an immune system response that, combined with genetic predisposition, can cause BIA-ALCL.^17,18 Hu et al studied breast capsule specimens of patients with BIA-ALCL and high-grade capsular contracture and concluded that biofilm formation by Gram-negative bacteria (eg, Ralstonia picketti, Pseudomonas, Brevundimonas) may trigger a lymphocytic immune response that can ultimately lead to BIA-ALCL. Interestingly, biofilm formation by Gram-positive bacteria (eg, Staphylococcus) is linked to capsular contracture.¹⁸

We support the abandonment of macrotextured implants in light of patient safety. Macrotextured breast implants have also been associated with late seroma and double capsule.¹⁹ Nevertheless, (macro)textured breast implants have certain advantages over other implants. “Bottoming out” occurs less frequently with textured breast implants due to tissue adherence and stronger capsular formation. This has also previously been described by Randquist and Gribbe in combination with low rates of capsular contracture, rupture, rippling, visibility, and reoperation.²⁰ Textured implants also displace less frequently, which is especially of importance in anatomic breast implants.

Breast implant placement is an interesting subject of discussion in alloplastic breast surgery. Adams et al previously proposed a 14-point plan for breast implant placement to reduce the risk of BIA-ALCL.²¹ The authors advocate for dual-plane placement of macrotextured breast implants. It is well known that subpectoral placement decreases the rate of capsular contracture whereas smooth implants increase it.^14,22 When designing this study, we hypothesized that a switch towards smooth breast implants may have led to more implants being placed subpectorally or dual-plane. Our data refute this theory, yet the majority of surgeons already placed implants dual-plane or submuscular. Regardless, it is good to note that a direct link between breast implant placement and BIA-ALCL has so far not been found. However, one may expect that increased coverage of the breast implant in the subpectoral plane may somewhat hide ipsilateral swelling of the breast, which is a well-known symptom of BIA-ALCL.

Strengths and Limitations of the Study

This study gives an accurate and up-to-date description of changes in practice by surveying colleagues through the largest and most renowned plastic surgery association in the Netherlands. Breast implants remain a key part of cosmetic and reconstructive surgery and it is important to continuously self-evaluate and share information with colleagues in light of patient safety. It is essential for plastic surgeons to remain updated in order to adequately inform and consult patients. We believe it is especially of importance in the case of BIA-ALCL, with which we have only recently become familiarized. Although the response rate was acceptable at 21.7%, the sample size is small and may be considered a limitation, but we believe that it is representative for a relatively small country such as the Netherlands. Despite that fact that this study was only performed among Dutch plastic surgeons, similar trends are likely to be seen all over the world. Prior to writing the article, we also distributed the survey through the European Association of Plastic Surgery. Unfortunately, the survey response rate was low at 10% (28 out of at least 270). For this reason, we decided to shift our focus to our own nation and contribute to the literature from an environment that is known to us and more accurately investigated with our data. Tables 2 to 4 present the data of the 28 non-Dutch plastic surgeons. Unfortunately, it is hard to paint a picture of how practice was impacted for colleagues who did not participate in this study which may introduce some nonresponder bias. Moreover, survey research methodologically provides a lower level of evidence. Regardless, we believe it is unlikely to differ significantly from our findings. We did not use the classification of Jones et al to classify breast implant surface area/roughness into 4 categories (high, intermediate, low, and minimal) correlating to biofilm formation, which could also be considered a limitation of this study.²³

CONCLUSIONS

Our data show that BIA-ALCL has had a significant impact on the use of macrotextured breast implants by Dutch plastic surgeons in both aesthetic and reconstructive breast surgery; these implants have been abandoned due to worldwide familiarity with BIA-ALCL. Microtextured and smooth/nanotextured breast implants are now most frequently used. Breast implant placement technique has not been affected. Dual-plane breast implant placement is still the most favored technique for breast augmentation, and submuscular placement is still most favored for breast reconstruction.

Supplemental Material

This article contains supplemental material located online at www.aestheticsurgeryjournal.com.

Disclosures

The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.

Funding

The authors received no financial support for the research, authorship, and publication of this article.

REFERENCES

Author notes