Breast Surgery Aesthetic Surgery Journal 2016, Vol 36(6) 672–680 Low Risk of Skin and Nipple Sensitivity and © 2016 The American Society for Aesthetic Plastic Surgery, Inc. This is an Open Access article Lactation Issues After Primary Breast distributed under the terms of the Creative Commons Attribution- Augmentation with Form-Stable Silicone NonCommercial-NoDerivs licence (http://creativecommons.org/ Implants: Follow-Up in 4927 Subjects licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that Herluf G. Lund, MD, FACS; Janet Turkle, MD; Mark L. Jewell, MD; the work is properly cited. For commercial re-use, please contact and Diane K. Murphy, MBA [email protected]. DOI: 10.1093/asj/sjv266 www.aestheticsurgeryjournal.com Abstract Background: Natrelle 410 implants (Allergan, Inc., Irvine, CA) are approved in the United States for breast augmentation, reconstruction, and revision. Objectives: To assess the risk of nipple and skin sensation changes and lactation issues in subjects receiving implants for primary breast augmentation and ascertain whether differences based on incision site exist. Methods: We used 410 Continued Access study data to assess safety and effectiveness of devices implanted via inframammary or periareolar incision sites. Subjects were evaluated preoperatively and at 4 weeks, 6 months, and annually up to 10 years postoperatively. Lactation issues and nipple and skin sensation changes (hypersensitivity/paresthesia, loss of sensation) were assessed. Results: The inframammary and periareolar cohorts comprised 9217 and 610 implanted devices, with mean follow-up of 4.1 years (range, 0-10.1 years) and 4.8 years (range, 0-10.1 years), respectively. In the inframammary cohort, risk of first occurrence of nipple sensation changes was 0.3% (95% CI: 0.2-0.5) at week 4 and month 6, and 0.4% (0.3-0.7) at year 10. Risk of skin sensation changes was 0.0% (95% CI: 0.0-0.2) at week 4, 0.1% (0.0-0.2) at month 6, and 0.1% (0.0-0.3) at all subsequent time points. No nipple or skin changes occurred in the periareolar cohort. Incidence of lactation issues was similar to that reported in postpartum women who did not have breast implants. Conclusions: We found that the risk of nipple or skin sensation changes and lactation issues is low and provide long-term safety and effectiveness data on subjects receiving implants for primary breast augmentation. Level of Evidence: 3 Accepted for publication December 1, 2015; online publish-ahead-of-print April 26, 2016. Therapeutic Breast augmentation is among the most common cosmetic Dr Lund is a plastic surgeon in private practice in Chesterfield, MO. surgery procedures worldwide, with approximately 287,000 Dr Turkle is a plastic surgeon in private practice in Carmel, IN. 1 procedures performed in the United States alone in 2014. Dr Jewell is a plastic surgeon in private practice in Eugene, OR. Silicone gel-filled implants have been used for breast aug- Ms Murphy is the Director of Clinical Development at Allergan plc, mentation for more than 50 years.2 Implant characteristics Irvine, CA. have changed greatly during that time, from having limited Corresponding Author: available sizes (ie, volume), shapes, and textures to having Dr Herluf G. Lund, St. Louis Cosmetic Surgery, 17300 N Outer 40 Road, a variety of dimensional and silicone gel-filled styles. Over #300, Chesterfield, MO 63005, USA. the years, surgical methodology and operational techniques E-mail: [email protected] Lund et al 673 have evolved from an experiential approach to analytical or aplasia. All subjects were required to have adequate tissue quantitative measurement.3,4 available to cover the implants and be willing to follow all While rates of certain adverse events, such as capsular study requirements. contracture, are well documented for many implant types,5 other potential complications of breast implants are not as Data Analysis well documented. Specifically, a limited number of articles Subjects were evaluated pre- and postoperatively at 0 to have reported on the potential effect of breast implants on 4 weeks, 6 months, and annually for up to 10 years following nipple or skin sensitivity and on lactation in women undergo- primary implant surgery. Written case report forms (CRFs) ing primary breast augmentation. This study reports on the were used for data collection in this study; investigators re- risk of nipple and skin sensation changes and lactation issues viewed and signed the CRFs and carried the ultimate re- in subjects receiving Natrelle 410 breast implants (Allergan sponsibility for the accuracy and completeness of the data plc, Dublin, Ireland) for primary breast augmentation. provided. Nipple hypersensitivity/paresthesia or loss of nipple sensation changes and skin hypersensitivity/paresthe- METHODS sia or loss of skin sensation changes were captured prospec- tively on a complications CRF. Data on severity, treatment, Study Design and resolution status were collected. Those reported as mod- This analysis, based on data collected through July 31 2014, erate, severe, or very severe, but not as mild or very mild, in the 410 Continued Access study, assessed the safety and were counted. Overall nipple and skin sensation changes effectiveness of Natrelle 410 implant devices. Natrelle 410 were compiled from the data collected on the CRF. Risk breast implants are form-stable, teardrop-shaped devices of first occurrence of overall nipple sensation changes (ie, filled with a highly cohesive silicone gel.3 Each implant style nipple hypersensitivity/paresthesia plus loss of nipple sensa- has a Biocell (Allergan plc, Dublin, Ireland) textured shell tion) was calculated; risk of first occurrence, resolution surface with irregularly spaced depressions and a mean pore status, and time to resolution were also calculated for individ- diameter of 300 µm (range, 100-600 µm).6-8 Natrelle 410 ual variables (nipple hypersensitivity/paresthesia and loss of breast implants were approved by the US Food and Drug nipple sensation). Similarly, risk of first occurrence of overall Administration in 2013.9,10 Long-term safety, effectiveness, skin sensation changes was calculated; risk of first occur- and subject satisfaction are supported by results from a rence, resolution status, and time to resolution were also 10 year, multicenter prospective study.11 calculated for individual variables (skin hypersensitivity/ Devices were implanted by surgeons certified by the paresthesia and loss of skin sensation). For subjects experi- American Board of Plastic Surgery with experience placing encing nipple or skin sensation changes, time to resolution silicone-filled implants; investigators were required to have was reported for those with resolution. participated in the pivotal study.11 The study was conducted Some subjects became pregnant following implantation in compliance with the US Food and Drug Administration re- and opted to breastfeed their babies. Lactation issues were quirements.12 Before enrolling subjects, an institutional review assessed before and after implantation as reported on the board (IRB) at each site approved the study protocol (the full medical history or follow-up CRF, as applicable. Information list of approving IRBs is available online as Supplementary collected included whether breastfeeding was attempted, material, at www.aestheticsurgeryjournal.com). All subjects the number of children for whom breastfeeding was attempt- provided written informed consent before surgery. ed, the number of children who were successfully breastfed, and any lactation problems that occurred. Lactation prob- lems were defined as inadequate milk production, excessive Subjects milk production, mastitis, pain, and “other.” Device assess- ments at year 8 were conducted by asking physicians if the The 410 Continued Access study enrolled female subjects shape of the breast reflected the shape of the implant (yes or aged 18 years or older, presenting for primary breast aug- no) and if the breast implant maintained its original position mentation, primary breast reconstruction, or breast implant (yes or no). revision surgery. Inclusion and exclusion criteria were identical to those previously detailed in the published pivotal Statistical Analysis study.13 Here, we report results for subjects exclusively undergoing primary breast augmentation who underwent Kaplan-Meier analyses of the rates of sensation problems surgical implantation of devices via inframammary or periar- were performed to assess the risk of first occurrence of the eolar incision sites, the two most common surgical approach- development of changes in nipple and skin sensation. The es in clinical practice.14 Eligible subjects aged 18 years or cumulative risk ratio and its 95% confidence interval (CI) older underwent primary breast augmentation because of were calculated for assessments of risk. No hypothesis tests dissatisfaction with breast size or shape, asymmetry, ptosis, of predictors were performed because of the low incidence 674 Aesthetic Surgery Journal 36(6) Table 1. Baseline Demographics and Characteristics Table 1. (Continued) Characteristic Inframammary Periareolar Characteristic Inframammary Periareolar Incision Incision Incision Incision Primary augmentation cohort Not provided 10 (0.2) 0 (0.0) Number of subjects 4621 306 Lactation sub-cohort Age, years, median (range) 36 (18-72) 36 (18-82) Number of subjects 294b 19 Body mass index, kg/m2 Age, years, median (range) 28 (18-52) 32 (26-46) Median (range) 20.8 (15.4-47.0) 21.7 (16.5-40.4) Pregnancies/live births in subjects with 145 7 no prior pregnancies Race,a no. (%) Pregnancies/live births in subjects with 159 12 White 4121 (88.9) 260 (83.6) prior pregnancies Asian 215 (4.6) 11 (3.5) aSubjects were allowed to select more than one response. bIn the inframammary subgroup, 294 subjects attempted breastfeeding after 304 pregnancies. Hispanic 125 (2.7) 18 (5.8) Black 51 (1.1) 6 (1.9) of occurrences. Descriptive statistics were used in all other analyses. Other 47 (1.0) 7 (2.3) Not provided 74 (1.6) 9 (2.9) RESULTS Marital status,a no.