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Implants filled with silicone gel or salt water used to rebuild a breast after mastectomy. They are not lifetime devices: some need replacing, and the FDA requires a warning and a checklist that patients read before agreeing to them.
Breast implants are class III devices in the United States, approved by PMA. Silicone gel-filled implants (product code FTR) include Allergan's Natrelle (P020056) and Mentor's MemoryGel (P030053), both approved on 17 November 2006, Sientra's silicone gel implants (P070004, 9 March 2012, now held by Tiger Aesthetics Medical), Allergan's Natrelle highly cohesive silicone-filled implants (P040046, 20 February 2013) and Mentor MemoryShape (P060028, 14 June 2013), and Motiva SmoothSilk implants (P230005, 26 September 2024). Saline-filled implants (code FWM) are Natrelle saline (P990074) and Mentor's saline-filled and Spectrum implants (P990075), both approved on 10 May 2000.
The FDA's breast implant page lists the actions that shape choice today: the request of 24 July 2019 that Allergan voluntarily recall Natrelle BIOCELL textured breast implants and tissue expanders from the market; labeling guidance from September 2020 adding a boxed warning and a patient decision checklist; and orders on 27 October 2021 restricting sale and distribution so that patients receive that risk information before surgery. The FDA lists local complications that occur in at least 1 per cent of patients, including capsular contracture, rupture and further operations, and describes the systemic symptoms some patients call breast implant illness. England's Breast and Cosmetic Implant Registry was launched in October 2016 after the high rupture rate of Poly Implant Prothese (PIP) implants and the inability to trace affected women, according to the plastic surgery associations (BAPRAS).
An elastomer silicone shell filled with silicone gel or saline is placed under or over the chest muscle, often after a tissue expander has stretched the skin, to restore breast volume and shape.
Query for this technology: (TITLE:"Breast implants for reconstruction" OR ABSTRACT:"Breast implants for reconstruction" OR TITLE:"silicone gel, saline and shaped cohesive gel" OR ABSTRACT:"silicone gel, saline and shaped cohesive gel" OR TITLE:"Breast implant" OR ABSTRACT:"Breast implant" OR TITLE:"Silicone breast implant" OR ABSTRACT:"Silicone breast implant") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Breast implants for reconstruction (silicone gel, saline and shaped cohesive gel), not a curated reading list.
Shares External breast prostheses, mastectomy bras and nipple prostheses, Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
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