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Allergan's silicone gel breast implants.
1Department of Plastic Surgery, Georgetown University Hospital, 3800 Reservoir Road, N.W., 1 PHC, Washington, DC 20007, USA. scott.l.spear@medstar.net
Silicone gel-filled breast implants are safe and effective for augmentation, revision, and reconstruction. Studies show no increased risk of cancer, autoimmune disease, or other serious health issues.
Area of Science:
- Plastic Surgery
- Biomaterials Science
Background:
- Women in the USA can choose between saline and round silicone gel-filled breast implants.
- Form-stable, highly cohesive silicone gel implants are available internationally and under FDA review.
Purpose of the Study:
- To investigate the safety and effectiveness of Allergan's round and anatomical (Style 410) silicone gel-filled breast implants for US marketing approval.
Main Methods:
- Clinical studies were conducted by Allergan to assess device safety and efficacy.
Main Results:
- The most frequent complications included reoperation, implant removal/replacement, malposition, and capsular contracture.
- Scientific literature indicates silicone gel-filled implants do not elevate risks of cancer, autoimmune disease, reproductive issues, or suicide.
- FDA approved round silicone gel-filled devices in 2006.
Conclusions:
- Silicone gel-filled breast implants demonstrate safety and effectiveness for various procedures.
- Advancements in cohesive implant technology allow for more personalized breast augmentation, revision, and reconstruction surgeries.
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