The group concluded that late periprosthetic fluid collection (arbitrarily defined as occurring ≥ 1 year after implant) is an infrequently reported occurrence (0.1 percent) after breast implant surgery and that, at a minimum, management should include clinically indicated ultrasound-guided aspiration of fluid, with appropriate cultures and cytologic testing. Further evaluation and additional treatment is recommended for recurrence of periprosthetic fluid collection after aspiration, or clinical suspicion of infection or neoplasia.

Therapeutic, IV.

With the recent voluntary recall by Allergan of their Biocell textured implants, many plastic surgeons are left with questions of how to best manage asymptomatic patients who have concerns about having these devices. We realized that there is no clear, published recommendations or scientific data to guide surgeons on how to discuss options with their patients and recommendations for surgical management in this uncharted territory. Using available literature and personal experience, we answer the most common questions we are hearing from our plastic surgery colleagues.

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Background Breast Implant Illness (BII) is a term used to describe a variety of symptoms by patients with breast implants for which there are no abnormal physical or laboratory findings to explain their symptoms. There currently exists a difference of opinion among clinicians and patients concerning the diagnosis and treatment of patients self-reporting BII. Objectives The first aim of this study was to determine if there is a valid indication for "en bloc" capsulectomy in patients self-reporting BII and if the type of capsulectomy performed alters long-term symptom improvement. The second goal was to identify any clinical laboratory differences between the cohorts. This study was funded by the Aesthetic Surgery Education and Research Foundation (ASERF). Methods A prospective blinded study enrolled 150 consecutive subjects divided equally into three cohorts: (A) women with systemic symptoms they attribute to their implants who requested implant removal, (B) women with breast implants requesting removal or exchange who do not have symptoms they attribute to their implants, and (C) women undergoing cosmetic mastopexy who have never had any implanted medical device. The subject's baseline demographic data and a systemic symptoms survey, including PROMIS ® validated questionnaires, was obtained before surgery and at 3-6 weeks, 6 months, and one year. Blood was collected from all three cohorts and implant capsules were collected from Cohorts A and B. Results 150 patients were enrolled between 2019- 2021. Follow-up at 3-6 weeks for all three cohorts was between 98-100%, 78-98% at 6-months, and one year data is currently at 80%. The type of capsulectomy; intact total, total, or partial all showed similar symptom improvement with no statistical difference in the reduction of symptoms based on the type of capsulectomy. Conclusions This study addresses one of the most discussed questions by plastic surgeons, patients, their advocates, and social media. The findings show that patients who self-report BII demonstrate a statistically significant improvement in their symptoms after explantation and that this improvement persists for at least 6 months. This improvement in self-reported systemic was seen regardless of the type of capsulectomy performed.

During the U.S. Food and Drug Administration's advisory panel hearings to evaluate the premarket approval for conventional silicone gel implants on October 14 and 15, 2003, panel members and patient advocate representatives focused on four specific areas of concern: reoperation rates in primary breast augmentation; levels, depth, and methods of patient education and informed consent; modes, frequency, and management of silicone gel implant device failures, including management of "silent" ruptures; and methods of monitoring and managing symptoms or symptom complexes that may or may not be associated with connective tissue disease or other undefined symptom complexes. These concerns, with a reported 20 percent reoperation rate for primary augmentation within just 3 years, and a lack of concise, definitive management protocols addressing these areas of concern may have contributed to the Food and Drug Administration's rejection of the premarket approval, despite the panel's recommendation for approval. This article presents decision and management algorithms that have been used successfully for 7 years in a busy breast augmentation practice (Tebbetts and Tebbetts). The algorithms have been further expanded and refined by a group of surgeons with diverse experiences and expertise to address the following clinical situations that coincide with concerns expressed by patients and the Food and Drug Administration: implant size exchange, grade III to IV capsular contracture, infection, stretch deformities (implant bottoming or displacement), silent rupture of gel implants, and undefined symptom complexes (connective tissue disease or other). In one practice (Tebbetts and Tebbetts) that uses the TEPID system (tissue characteristics of the envelope, parenchyma, and implant and the dimensions and fill distribution dynamics of the implant), implant selection is based on quantified patient tissue characteristics, pocket selection is based on quantified soft-tissue coverage, and anatomic saline implants have fill volumes that are designed to minimize shell collapse and fold fatigue; in this practice, the algorithms contributed to a 3 percent overall reoperation rate in 1662 reported cases with up to 7 years of follow-up, compared with a 20 percent reoperation rate at 3 years in the 2003 premarket approval study.

5.