Outcomes of Implant Removal and Capsulectomy for Breast Implant Illness in 248 Patients

Jacob Y. Katsnelson, MD; Joseph R. Spaniol, MD; Joshua C. Buinewicz, BA; Frederick V. Ramsey, PhD; Brian R. Buinewicz, MD, FACS


Plast Reconstr Surg Glob Open. 2021;9(9):e3813 

In This Article


A total of 248 patients underwent bilateral implant removal with capsulectomy performed by the senior author from August 2016 to February 2020. Two hundred and twenty-six patients (93%) had implants placed for cosmetic purposes. The median patient age at presentation was 45 years (range: 22–72 y), median age at placement of first implants was 29.5 and average BMI was 24. On physical examination, 130 patients (55%) exhibited Baker II and 95 patients (39%) exhibited Baker III/IV capsular contracture at initial presentation. Patient characteristics are summarized in Table 1.

The most common symptoms mentioned at time of initial evaluation included generalized pain, fatigue, cognitive "fogginess," migraines, headaches, anxiety, arthritis, vision changes, dyspnea, hair loss, weight gain, back pain, rashes, generalized gastrointestinal issues, and depression. The number of complaints did not vary significantly between types of implants. Symptoms are summarized in Figure 1.

Figure 1.

Most common complaints reported by patients on initial evaluation.

Operative details and findings are shown in Table 2. Simultaneous procedures at time of implant removal and total capsulectomy included mastopexy in 53 patients (21%), scar revision in 12 patients (4.9%), breast reconstruction in five patients (2.0%), and abdominoplasty in one patient (0.4%). One patient requested implant replacement of her silicone implants with saline implants combined with capsulectomy (0.4%). Implant rupture at time of explantation was noted in 20 patients on the right (8.2%), and 18 patients on the left (7.4%). Two hundred forty-four patients (98.3%) underwent total capsulectomy on the right and 245 patients (98.7%) had total capsulectomy on the left. Two patients had a partial excision of the capsules bilaterally, and one patient had no capsulectomy performed. The capsules were removed intact in 27 patients (10.8%) on the right and 28 patients (11.2%) on the left. There were six major complications, which consisted of one pneumothorax that required hospital admission for observation, three breast hematomas that required evacuation in the odds ratio (OR), and two deep vein thromboses that were managed with anticoagulation. Minor complications consisted of five delayed seromas and three liquified hematomas which were treated by aspiration. Three patients who underwent simultaneous mastopexies had a suture infection which was treated with antibiotics.

Ninety-eight patients (40.2%) had silicone implants, and 146 (59.8%) had saline implants. Silicone implants included 38 Allergan silicone (21%), 32 Mentor silicone (18%), and six Sientra silicone (3%). Saline implants included 71 Mentor saline (39%), 34 Allergan saline (19%), and one IDEAL saline (0.6%). In 63 patients, the brand of implant could not be determined. Two hundred and seven patients (85%) had smooth implants, and 37 (15%) had textured implants (Figure 2).

Figure 2.

Characteristics of removed implants. A, Make and model. B, Texture and fill.

All capsules were submitted to permanent pathology, and 111 (23%) of the capsules were found to have evidence of acute or chronic inflammation. One capsule did have atypical lymphocytic infiltration but was CD30 negative in testing for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Positive cultures were noted in fourteen patients, eight (3.28%) from right breast pockets, and nine (3.69%) from left breast pockets. The most common organisms from cultures included several strains of Staphylococcus as shown in Table 3. One patient had cultures positive for Candida albicans from both breast pockets and underwent a 2-week course of fluconazole after consultation with an infectious disease specialist but had an otherwise uneventful postoperative course. Twelve patients (4.9%) had capsular findings of "refractile/nonpolarizable foreign material or silicone." Of these patients, three had bilateral implant rupture, four had one ruptured and one unruptured implant, and five had no evidence of rupture. All of these patients had histiocytic reactive changes, macrophages, or multinucleated cells associated with the refractile material on histology. Four of these patients had saline implants and eight had silicone implants at time of explantation (Table 4).

Capsular inflammation was significantly associated with silicone implants vs. saline implants (right: 31.3% silicone versus saline 16.4%, P = 0.007; left: 29.9% silicone versus 15.1% saline, P = 0.005). Additionally, inflammation was significantly associated with textured implants versus smooth implants (right: 38.9% textured versus 19.9% smooth, P = 0.01; left: 37.8% textured versus 18.5% smooth, P = 0.008). Figure 3 shows rates of inflammation by implant type.

Figure 3.

Rates of inflammation by implant type. A, implant fill. B, implant texture.

On logistic regression modeling, capsular inflammation was independently associated with silicone versus saline (right: OR = 2.18 [1.16–4.11], P = 0.016, Left: OR = 2.25 [1.17–4.31], P = 0.015) and textured versus smooth implants (right: OR = 2.26 [1.04–4.9], P = 0.040, left: OR = 2.35 [1.08–5.12], P = 0.031) (Figure 4). Textured and silicone characteristics independently increased inflammation when present together to approximately 51% but had an additive rather than synergistic effect on increasing inflammation.

The average number of follow-up visits was 3.9 ± 2.1, with a duration of 1.8–6 months. Postoperative visit notes addressed specific symptoms in 46 patients, and of these, 44 (96%) reported a decrease in the number of symptoms after surgery. Of 228 patients reporting their level of satisfaction with the procedure at first postoperative visit, 206 (90.4%) reported they were satisfied with the results and had no or minor complaints. In subsequent follow-up visits, 125 of 153 (81.7%) patients reported high satisfaction at their second postoperative visit, 59 of 75 (78.7%) reported high satisfaction at their third postoperative visits, and 30 of 39 (77%) reported high satisfaction at the fourth postoperative visit.

Figure 4.

Logistic regression modeling for ORs with regards to texturing and implant fill.