Dr. Laverson now using FDA approved “Gummy Bear” Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for appropriate Breast Augmentation/Breast Enhancement San Diego Patients
After 15 plus years availability in Europe, recent FDA approval of Allergan highly cohesive gel implants now provide additional options for breast augmentation San Diego patients of Dr. Steve Laverson at the private Feel Beautiful Plastic Surgery Clinic in Encinitas, CA.
What are “Gummy Bear” Implants?
These breast implants have a solid silicone outer shell which is filled with silicone gel. The gel in Allergan’s “Gummy Bear” Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant has additional polymer cross-links relative to gel in previously approved silicone gel-filled breast implants. Cross-linking refers to the bonds that link one silicone molecular chain to another. The higher level of silicone cross-linking results in a firmer gel. The term “gummy bear” refers to the semi-solid consistency of highly cohesive silicone gel, compared to viscous gel of regular breast implants. Traditional silicone gel implants have cohesive silicone gel which is very viscous, but changes shape more easily than form stable semi-solid highly cohesive “gummy bear” fill in the new Allergan Style 410 implants.
Other elements specific to highly cohesive breast implants are germane in selection of these devices. Because they are not as deformable, “gummy bear” implants may require a longer surgical incision than saline or less cohesive silicone gel-filled breast implants. Investigational studies identified “gel fracture” as a new phenomenon unique to highly cohesive silicone gel. Gel fracture is a long lasting fissure, or crack, of cohesive gel fill within an intact solid silicone breast implant shell. Although no patients have been adversely affected by gel fracture in studies conducted to date, post FDA approval studies will investigate gel fracture further.
Gummy bear implants are available in various sizes and shapes with granular surfaces that help grasp surrounding breast and chest tissue, immobilizing the implants where placed at the time of surgery by Dr. Laverson. Highly cohesive implants are also appropriate for breast implant revision surgeries, which correct or improve the result of an original breast augmentation San Diego procedure.
FDA Post-Approval Studies Summary:
As conditions of approval, the FDA required Allergan, Inc. to conduct four post-approval studies to characterize the long-term performance and safety of the devices. Post-approval investigation of Natrelle 410 Anatomically Shaped gummy bear silicone gel-filled breast implants included:
- US Post Approval Study- To document long-term results by enrolling more than 2,000 silicone gel-filled breast implant patients and following them for 10-years
- Case-Control Studies – To identify rare adverse events by enrolling 11,500 women in five case-control studies on rare connective tissue diseases, neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma.
- Continued Access Study – To collect additional safety and effectiveness data from about 3,500 women who received these implants prior to approval but outside of the Core Cohort Study.
- Focus Group Study – To improve the format and content of the patient labeling.
In addition, explant analysis will be conducted for all Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants that are removed from patients and returned to the manufacturer.