Allergan Style 410 Implants for Breast Reconstruction: A Prospective Study in Efficacy, Safety, and Symmetry

Jacob G. Unger, Jennel M. Carreras, Purushottam Nagarkar, Haneol S. Jeong, William Carpenter

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background: Implant-based breast reconstruction is performed with both saline and silicone. In 2001, a study was conducted in which a novel implant made of highly cohesive silicone gel in anatomical shape was used. It differs from others because it holds its anatomical shape and forces tissue to conform to the implant. Methods: Two hundred twelve consecutive patients who underwent reconstruction with Allergan 410 cohesive gel anatomical implants were enrolled prospectively over a 12-year period. Complications and satisfaction rates were recorded. Results: Average age of the patients was 48.5 years and average body mass index was 24.1 kg/m2. Bilateral reconstruction was performed in 83 percent of patients. Long-term follow-up was achieved in all patients and averaged 3.3 years (range, 0.5 to 10.2 years). The overall complication rate was 19.8 percent; most were minor complications, such as rippling (9.4 percent) and asymmetry (4.2 percent). Major complications included infection (2.4 percent), malposition (1.4 percent), capsular contracture (0.9 percent), seroma (0.5 percent), extrusion (0.5 percent), and implant rupture (0.5 percent). The rate of implant-related reoperation, excluding cancer recurrence, was 9.0 percent, consisting of implant replacement (5.7 percent), implant removal (1.9 percent), and implant repositioning (1.4 percent). Patient satisfaction averaged 4.83 (range, 2 to 5) on a five-point scale. Surgeon satisfaction averaged 4.9 (range, 2 to 5). Conclusions: Allergan 410 cohesive gel anatomical implants have a favorable risk profile in reconstruction, with excellent patient and surgeon satisfaction. This novel implant allows for a paradigm shift in implant-based breast reconstruction. Surgeons can now use an implant to help shape the final contour of the breast mound rather than rely on mastectomy flaps and suture techniques to create aesthetic contours needed to create an attractive breast reconstruction.

Original languageEnglish (US)
Pages (from-to)548-555
Number of pages8
JournalPlastic and Reconstructive Surgery
Volume138
Issue number3
DOIs
StatePublished - Sep 1 2016

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Mammaplasty
Prospective Studies
Safety
Patient Satisfaction
Gels
Silicone Gels
Seroma
Suture Techniques
Mastectomy
Contracture
Silicones
Esthetics
Reoperation
Rupture
Breast
Body Mass Index
Recurrence
Infection
Surgeons
Neoplasms

ASJC Scopus subject areas

  • Surgery

Cite this

Allergan Style 410 Implants for Breast Reconstruction : A Prospective Study in Efficacy, Safety, and Symmetry. / Unger, Jacob G.; Carreras, Jennel M.; Nagarkar, Purushottam; Jeong, Haneol S.; Carpenter, William.

In: Plastic and Reconstructive Surgery, Vol. 138, No. 3, 01.09.2016, p. 548-555.

Research output: Contribution to journalArticle

Unger, Jacob G. ; Carreras, Jennel M. ; Nagarkar, Purushottam ; Jeong, Haneol S. ; Carpenter, William. / Allergan Style 410 Implants for Breast Reconstruction : A Prospective Study in Efficacy, Safety, and Symmetry. In: Plastic and Reconstructive Surgery. 2016 ; Vol. 138, No. 3. pp. 548-555.
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abstract = "Background: Implant-based breast reconstruction is performed with both saline and silicone. In 2001, a study was conducted in which a novel implant made of highly cohesive silicone gel in anatomical shape was used. It differs from others because it holds its anatomical shape and forces tissue to conform to the implant. Methods: Two hundred twelve consecutive patients who underwent reconstruction with Allergan 410 cohesive gel anatomical implants were enrolled prospectively over a 12-year period. Complications and satisfaction rates were recorded. Results: Average age of the patients was 48.5 years and average body mass index was 24.1 kg/m2. Bilateral reconstruction was performed in 83 percent of patients. Long-term follow-up was achieved in all patients and averaged 3.3 years (range, 0.5 to 10.2 years). The overall complication rate was 19.8 percent; most were minor complications, such as rippling (9.4 percent) and asymmetry (4.2 percent). Major complications included infection (2.4 percent), malposition (1.4 percent), capsular contracture (0.9 percent), seroma (0.5 percent), extrusion (0.5 percent), and implant rupture (0.5 percent). The rate of implant-related reoperation, excluding cancer recurrence, was 9.0 percent, consisting of implant replacement (5.7 percent), implant removal (1.9 percent), and implant repositioning (1.4 percent). Patient satisfaction averaged 4.83 (range, 2 to 5) on a five-point scale. Surgeon satisfaction averaged 4.9 (range, 2 to 5). Conclusions: Allergan 410 cohesive gel anatomical implants have a favorable risk profile in reconstruction, with excellent patient and surgeon satisfaction. This novel implant allows for a paradigm shift in implant-based breast reconstruction. Surgeons can now use an implant to help shape the final contour of the breast mound rather than rely on mastectomy flaps and suture techniques to create aesthetic contours needed to create an attractive breast reconstruction.",
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