Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to maintain a record of safety and performance with all medical implants.
This study is designed to collect data on a new generation of smooth mammary implants to assess the long term performance and safety data on this type of gel-filled mammary breast implant.
The two main complications of breast implants are capsular contracture and rupture; these complications can take years to develop. The study is designed to evaluate the occurrence of these two primary complication as well as other secondary complications over a period of 10 years. Patient follow up will be carried out pre-operatively and post operatively at 12 months and then 3, 5, 8 and 10 years thereafter.
The study will be carried out over 10 years to adequately assess complications which may only occur over the lifetime of the device such as systemic complications
Genetic female subjects aged ≥18 and ≤65
Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:-
Subjects undergoing implant augmentation with a BMI > 30 and undergoing reconstruction with a BMI >32.
Subjects with autoimmune disease, lung fibrocystic disease, conditions that interfere with wound healing and blood clotting, a weakened immune system, reduced blood supply to the breast tissue or any other condition for which breast implants are contraindicated.
Subjects who have participated in a clinical study which involve chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer related clinical studies.
Subjects with insufficient tissue covering due to either radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.
Female 18-65 requiring breast surgery for iether augmentation, reconstruction or revision, meeting inclusion and non inclusion criteria
Cohort
Prospective
PERLE Sterile Smooth Opaque gel filled mammary implants
DeviceSterile smooth opaque gel filled mammary implants will be implanted in adult women having breast surgery for either augmentation, reconstruction or revision surgery. Different ranges of implants will be used to suit patient needs
Rate of capsular contracture (Baker grade III-IV)
Rate of implant rupture
Rate of the secondary surgical procedures required for correction of complications
Rate and frequency of local complications associated with the use of Nagor gel-filled mammary implants
* Capsular contracture of Baker Grade I-II * Haematoma * Rupture * Seroma * Severe and continuing pain * Post-operative infection * Explantation as a result of infection * Implant displacement/extrusion * Wrinkling/folds * Breast Implant Associate Anaplastic Large Cell Lymphoma * BII/Asia * Delayed or abnormal wound healing occurring within the first 3 months of surgery * Any other complications considered by the Investigator to be related to the device or surgical procedure
Patient satisfaction
BREAST- Q method
rate and frequency of any adverse events
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