View clinical trials related to Breast Augmentation.
Filter by:The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures. The research will include 330 women, divided into two groups of 165 participants each (150 breast augmentation participants and 15 reconstruction participants). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica. The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates. After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5, 6 and 7) annually thereafter for a period of three consecutive years. In case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook.
The breasts are paired, superficial organs with relative symmetry. They particularly characterize femininity as an erogenous area, in addition to playing an extremely important role in a woman's body aesthetics. Breast augmentation surgery aims to add volume or restore breast volume lost post-pregnancy or weight loss, often establishing a balance in the body silhouette and increasing self-esteem. Breast implants cause an inflammatory reaction with the consequent formation of a fibrous capsule around the implant, which can evolve with different degrees of contraction. Different factors are involved with the formation and intensity of the peri-prosthetic capsule: presence of hematoma, sub-clinical infection, silicone leakage, type of prosthetic envelope, plane/site of prosthesis placement, immune response, among others. The involvement of the envelope texture proved to be a major factor in reducing the formation of capsular contracture, which was clearly evident when covering with polyurethane foam was used. It is estimated that this reduction is due to the three-dimensional structure obtained with this configuration, which would result in a smaller vector resultant of contraction of the capsular fibers. Aiming to obtain less capsular contracture, a silicone prosthesis with a velvet/silicone foam envelope was developed, which theoretically would have the advantage of the velvet/foam structure similar to polyurethane without, however, presenting negative aspects such as degradation, inflammation and eventual toxicity of catabolites. In this way, it is expected to prove the best postoperative evolution regarding the use of silicone prostheses with velvet/silicone foam coverage, highlighting the maintenance of the breast position over time. Furthermore, to intend to verify whether the velvet/silicone foam coverage determines a lower incidence of capsular contracture compared to the textured envelope. To this end, evaluation will be carried out through clinical examination and evaluation of digital photographic images taken pre-operatively, 30, 120, and 360 days post-operatively. After a long postoperative period (approximately 9 years), a late follow-up will be carried out with the patients with clinical evaluation and a satisfaction questionnaire.
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
Post-marketing surveillance study to demonstrate the silent rupture rate and satisfaction of patients who underwent a primary and revision breast augmentation surgery with Motiva Implants®, 3 to 10 years before enrollment.
This is a pilot, open label, single center study in 30 women undergoing breast augmentation. The study will assess and collect information on pharmacokinetics and safety of EXPAREL administered as a pectoral plane block. A total of 15 subjects will be enrolled in each of the 2 cohorts.
This study is a retrospective chart review and entails review of medical records of patients enrolled in about 5 hospitals/clinics in China, and who have undergone breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019. The safety of McGhan breast implants (textured and smooth) will be evaluated based on occurrence of local complications including capsular contracture, malposition of implant, seroma/late seroma and anaplastic large cell lymphoma (ALCL).
Among aesthetic or cosmetic surgeries, breast augmentation was the most frequently performed and the endoscopic transaxillary approach has become the preferred incision for Asian women. As breast augmentation must be performed under general anesthesia accompanied by its effects and potential complications, types of general anesthesia may affect the quality of recovery. Currently, the two most common techniques of general anesthesia are inhalation anesthesia (IH) and total intravenous anesthesia (TIVA). The effects of these types of general anesthesia on the quality of recovery have been investigated for numerous surgical procedures. However, no prior studies have analyzed different types of anesthesia used for performing transaxillary endoscopic breast augmentation. This prospective, parallel, randomized controlled study will evaluate the effects of inhalation anesthesia vs. total intravenous anesthesia on the quality of recovery in patients undergoing transaxillary endoscopic breast augmentation.
Split-body/face evaluator-blind study of the safety and performance of fractional RF for the treatment of surgical scars following breast augmentation, abdominoplasty or face lift. The study will enroll up to 50 female subjects requesting treatment of surgical scars following breast augmentation or abdominoplasty and up to 25 male and female subjects requesting treatment of surgical scars following face lift surgery. Subjects will receive a total of three treatments of their surgical scars at one-month intervals on one side of the body or face only. Subjects will be followed up at one, two, three and ten months after their last treatment. Outcomes will be compared to the non-treated side.
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.
A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants