![]() Connective tissue disease, breast cancer, and reproductive problems.Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma (cancer of the immune system).Capsular contracture, scar tissue (capsule) that forms around the implant and squeezes the implant.Additional surgeries, with or without removal of the device (also see Implant Removal Options). ![]() Implant complications, such as breast pain and changes in nipple and breast sensation.Some of the complications and adverse outcomes of breast implants include: The recommendations in this guidance supplement the recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued September 29 , 2020 superseding the prior version dated November 17, 2006. Silicone gel-filled breast implant rupture screening recommendations.Materials/device descriptions, including types and quantities of chemicals and heavy metals found in or released by breast implants.Patient decision checklist ( page 5 of the guidance).Boxed warning ( page 4 of the guidance).The final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, provides recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants, including: Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Final Guidance
0 Comments
Leave a Reply. |