PURPOSE:
The Inamed Style 410 cohesive silicone gel implant has been available outside of the United States since 1993. Experience in the United States has been limited to Inamed clinical investigators through FDA-approved clinical studies. This is a retrospective review of a single surgeon's experience with his first 100 patients using the Inamed 410 implant.
METHODS:
The author's first 100 patients using the Inamed Style 410 cohesive silicone gel implant for breast augmentation were included in the study. A retrospective chart review was performed to analyze patient indications for surgery, patient age, implant pocket placement, adjunct breast procedures, complications, capsular contracture and patient satisfaction. Patient follow-up was performed by using both postoperative examinations and surveys.
RESULTS:
100 patients underwent consecutive breast augmentation procedures using the Inamed Style 410 cohesive silicone gel implant. The average age was 37 years (20 years to 61 years). Average follow-up was 16 months (4 months to 34 months). 2 patients were lost to follow-up after 6 months. Seventy-seven (77%) patients had primary breast augmentations and twenty-three (23%) patients had revision of a breast augmentation. Eighty-three (83%) of the implants were placed in a partial subpectoral pocket and seventeen (17%) of the implants were placed under the fascia of the pectoralis major muscle. 33 patients underwent simultaneous mastopexy procedure. All revision patients underwent a full or near complete capsulectomy. 4 revision patients had tightening of the implant pocket performed prior to implant placement. 98 patients had a Baker grade 1 capsule on their last follow-up examination with 2 patients having a grade 2 capsule. There were no cases of implant rotation, malposition, or clinical evidence of implant rupture. There were 2 complications reported: 1 infected implant and 1 cyst at the incision site. Patient satisfaction was graded on a scale of “definitely satisfied” to” definitely dissatisfied”. 89% reported being “definitely satisfied”, 7% reported being “somewhat satisfied”, 3% reported being ‘neither satisfied nor dissatisfied', and 1% reported being” definitely dissatisfied”. The 4% reported below satisfied all expressed dissatisfaction with breast size.
CONCLUSION:
The experience with the Inamed Style 410 implant for breast augmentation has demonstrated a high degree of patient satisfaction and a low complication rate. Because of the 410 implant's form stable silicone gel matrix, the implant requires certain pre-operative and intra-operative factors be addressed in order to obtain the optimal result. Critical pre-operative planning includes: (1) Selection of the implant shape and size based upon the patient's physical characteristics and desires. (2) Implant placement is determined by the patient's breast characteristics. Because of the anatomic tear-drop shape and the form stable cohesive gel matrix of the 410 implant, thin patients with minimal breast tissue had very good results using a partial submuscular placement with minimal rippling or palpability. Patients with tuberous breasts had excellent results using a subfascial pocket allowing the form-stable gel matrix to shape the breast parenchyma. The increase lower pole projection of the tear-drop shape implant improved the breast appearance and shape in which a mastopexy and augmentation were performed. Critical intraoperative issues include: (1) Incision size: a slightly larger incision length may be required to avoid fracturing the gel matrix. (2) Precise pocket dissection is required to maintain correct implant orientation and tissue adherence to the 410 implant's BIOCELL surface. For revisions of previous breast augmentation, a capsulectomy is performed to enhance tissue interaction with the implant surface. Patients have expressed a high degree of satisfaction noting particularly the natural shaping of the breast and the more “breast like” feel of the implant when compared to saline filled or standard silicone gel filled implants. The Inamed Style 410 cohesive gel implant is a fourth generation silicone gel implant and represents a significant advance in implant technology. Due to its low complication rate and aesthetically pleasing results, the 410 implant will probably comprise a large percentage of the implants used for breast augmentation upon its approval and introduction into the United States.