Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1.  Caroline Glicksman, MD, MSJ, FACS, Patricia McGuire, MD, Marshall Kadin, MD, Marisa Lawrence, MD, Melinda Haws, MD, Jill Newby, PhD, Sarah Ferenz, BA, James Sung, MD, FCAP, Roger Wixtrom, PhD 

This was a landmark study performed to determine if “en bloc” capsulectomy is necessary for long-term symptom improvement.  150 patients were enrolled in the study and underwent either intact complete capsulectomy, complete capsulectomy, or partial capsulectomy. The patients were followed for six months. The authors found that 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. 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 symptoms was seen regardless of the type of capsulectomy performed.

Heavy Metals in Breast Implant Capsules and Breast Tissue: Findings from the Systemic Symptoms in Women–Biospecimen Analysis Study: Part 2 Roger Wixtrom, PhD, Caroline Glicksman, MD, MSJ, Marshall Kadin, MD, Marisa Lawrence, MD, Melinda Haws, MD, Sarah Ferenz, BA, James Sung, MD, FCAP, Patricia McGuire, MD

This was the second part of the study that aimed to determine whether heavy metals are present in the capsules around saline and silicone implants and if there are statistical differences in the type or level of these metals between women with or without symptoms. 150 patients were enrolled in the study and divided into three groups: 1) Women with self-reported BII,  2) Women with breast implants but did not report BII, and 3) women who never had breast implants.  Capsule tissue that was removed was analyzed for 22 heavy metals.  Heavy metal content was compared between the capsule tissue from Groups 1 and 2. The only statistically significant differences identified in Group 1 were higher levels of arsenic and zinc, and lower levels of cobalt, manganese, silver, and tin. There were no elevated levels or statistically significant differences in the other metals tested between Groups 1 and 2. Heavy metals were also detected in the non-implant Group 3 breast tissue.  In Group 3 (patients who never had implants), some had higher levels of metals than patients in Group 1 and 2 (patients with breast implants). Smoking, gluten-free diets, dietary supplements, and the presence of tattoos were all identified as statistically significant sources of arsenic and zinc in Group 1.