Commentary on: Complications of Aesthetic and Reconstructive Breast Implant Capsulectomy: An Analysis of 7486 Patients Using Nationwide Outcomes Data Free

See the Original Article here.

The decision of whether or not to undergo capsulectomy at the time of implant removal or exchange is an individual choice that should be made after a full discussion of risk vs benefit. Many factors can influence this decision, including the presence of capsular contracture, the integrity of the implant shell, whether the implant is textured or smooth, gel or saline, and concerns of patient and surgeon about the possibility of developing breast implant–associated malignancy. The patient's medical history and ability to tolerate the longer, more invasive, and potentially more expensive procedure are all factors to be considered. Having scientific data to aid in the discussion is essential for patients to determine what is best for their circumstance.¹

This paper, “Complications of Aesthetic and Reconstructive Breast Implant Capsulectomy: An Analysis of 7486 Patients Using Nationwide Outcomes Data, analyzed the Tracking Operations and Outcomes for Plastic Surgeons (TOPS) database.² TOPS is a national plastic surgery–specific database from the American Society of Plastic Surgeons that collates surgeon-reported procedures and their associated outcomes. This paper reviewed data from 2008 to 2019 for patients undergoing capsulectomy or capsulotomy for both aesthetic and reconstructive breast procedures. Importantly, there was also a control cohort of patients undergoing implant exchange without capsulectomy or capsulotomy. The database was analyzed for the 30-day complication profile for the 3 cohorts with the purpose of determining if the complication profile differed depending on whether a capsulectomy was performed and examining potential differences between aesthetic and reconstructive procedures.

The authors used Current Procedural Terminology (CPT) codes to stratify the 3 cohorts: CPT 19371 for capsulectomy, CPT 19370 for capsulotomy, and CPT 19342 for no capsulectomy. They reported 5042 patients in the capsulectomy cohort, 2444 patients in the capsulotomy cohort, and 2248 patients in the control cohort in which no capsulectomy or capsulotomy was performed.

As would be expected, the surgical time was longer in the capsulectomy cohort, with an average of 94.7 minutes, compared with 74.7 minutes for capsulotomy and 82 minutes for the control. The overall complication rate was 5.79% for the capsulectomy cohort, 4.5% for the capsulotomy cohort, and 4.4% for the control, which was statistically significant between the capsulectomy cohort and both control groups. The most common breast-specific complication was a 1% incidence of hematoma in the capsulectomy cohort, which was statistically higher than in the capsulotomy and control cohorts. If an implant exchange was performed, there was a significantly higher rate of seroma between the capsulectomy and capsulotomy cohorts. There was no difference in surgical site infection between the groups.

The authors also reported that complication rates were significantly higher in reconstruction patients than in aesthetic patients, with a higher risk for seroma, wound dehiscence, and implant loss when capsulectomy was performed. The reconstruction cohort included patients who had received radiation, which is a known risk factor for wound healing issues and infection, and more of the reconstruction procedures were performed in hospital, which could indicate the procedure was more complicated than those performed in an outpatient setting. Hematoma rates were not different between aesthetic and reconstruction patients.

The reported complication rate in this study was higher than previously reported in patients undergoing capsulectomy at the time of implant removal or exchange.^3,4 The authors hypothesize that this is due to a more extensive collection of variables and not being limited by those complications requiring surgical treatment or hospitalization. They found that capsulectomy was associated with significantly greater overall complication rates, with a 1.8-fold increased risk of hematoma rates compared with capsulotomy patients, and a 3.6-fold increase in seroma rates compared with controls.

There are many reasons to consider total, partial, or no capsulectomy. An en bloc capsulectomy refers to removal of an implant and capsule with a margin of uninvolved tissue, with the only indications being capsular-associated malignancy. The relative indications for a total capsulectomy, ie, removal of the entire capsule, are capsular contracture and intracapsular rupture. There are no current data showing that capsulectomy is a risk-reducing procedure for the development of capsular-associated malignancy, but it is considered reasonable for patient and surgeon to be concerned and request histological analysis of the capsule. There is also published evidence that capsulectomy is not required for symptom improvement in patients with systemic symptoms they attribute to their implants.⁵

A limitation of this paper is that the cohorts were determined based on reported CPT codes. The extent of capsulectomy in the CPT 19370 cohort is unknown and the application of codes may differ by surgeon for capsulectomy vs capsulotomy. A significant strength of this paper is the use of a no-capsulectomy control cohort which showed statistically significantly fewer overall complications than the capsulectomy and capsulotomy cohorts.

This paper is a welcome addition to the literature, allowing surgeons and patients to make educated choices based on published, scientific data. Patients are inundated with information from multiple sources, including social media groups and surgeons who promote themselves as explant or capsulectomy experts. These sources may present capsulectomy as the only option when considering removal or exchange of implants, rather than giving patients choices after a full discussion of the alternatives with the risk and benefit of each.⁶

Capsulectomy should not be treated as a “one size fits all” procedure and patients considering this procedure should be given options based on the most current scientific data. This paper provides plastic surgeons with further information to add to informed discussion with patients who are considering removal or exchange of their implants.

Disclosures

Dr McGuire is a clinical investigator for the Motiva (Establishment Labs Holdings, Inc., Alajuela, Costa Rica) US FDA clinical trials and a consultant for Establishment Labs Holdings, Inc (Alajuela, Costa Rica).

Funding

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

REFERENCES

Author notes