IDEAL IMPLANT Structured Breast Implants: Core Study Results at 6 Years

  title={IDEAL IMPLANT Structured Breast Implants: Core Study Results at 6 Years},
  author={Larry S. Nichter and Robert A. Hardesty and Gregg M. Anigian},
  journal={Plastic and Reconstructive Surgery},
  pages={66 - 75}
Background: The structured breast implant uses different technology than saline or silicone gel implants, making it a third type of implant. [] Key Method Methods: This U.S. trial enrolled 502 women: 399 primary augmentations and 103 replacements of existing augmentation implants. Investigators were 45 American Board of Plastic Surgery–certified plastic surgeons at 35 sites.
New Evaluation Procedure for Multi-Dimensional Mechanical Strains and Tangent Moduli of Breast Implants: IDEAL IMPLANT® Structured Breast Implant Compared to Silicone Gel Implants
Despite having a relatively inviscid saline fill, the IDEAL IMPLANT was found to be more shape stable compared to gel implants, which implies potentially less interaction with the capsule wall when the implant is subjected to compressive loads.
Plastic Surgeons Defend Textured Breast Implants at 2019 U.S. Food and Drug Administration Hearing: Why It Is Time to Reconsider
  • E. Swanson
  • Medicine
    Plastic and reconstructive surgery. Global open
  • 2019
A re-analysis of the true risks and benefits of textured implants is justified and it is time for professional societies to recognize that the device is the problem rather than surgical technique.
New technologies and innovations in breast surgery
The search for a breast implant that reduces possible and frequent complications, especially biofilm formation, infectious processes, and abnormal immune response, was the focus of most articles studied.
Use of Three-Dimensional Imaging to Assess the Effectiveness of Volume as a Critical Variable in Breast Implant Selection
Prioritizing volume as an implant selection variable in breast augmentation results in a very high rate of patient satisfaction, and this tool was judged to be very helpful, very accurate, and important in helping patients choose their desired implant size.
Current Trends in Breast Augmentation: Analysis of 2011-2015 Maintenance of Certification (MOC) Tracer Data.
Changes in standard of care for breast augmentation are reflected by the evolving practice patterns of plastic surgeons, best evidenced by the dramatic increase in use of antibiotic and DVT prophylaxis from 2011 to 2015.
Lateral and Inferior Implant Malposition in Prosthetic Breast Reconstruction: Incidence and Risk Factors
The effect of implant size on malposition was mediated through BMI, highlighting the interplay of implant and patient characteristics with respect to malposition, in the first study to identify risk factors for implant malposition after prosthetic breast reconstruction.
The evolution of breast prostheses
The evolution of breast implants is explored providing historical facts and technical details which have improved the initially primitive and limited devices to current‐day devices, which exhibit a tremendous range of surface textures, sizes, gel consistencies, and anatomical shapes.
Understanding the Evidence and Improving Outcomes with Implant-Based Prepectoral Breast Reconstruction
Once considered to have an unacceptable complication profile, prepectoral breast reconstruction is increasing in popularity because of decreased surgical invasiveness and postoperative pain and the absence of animation deformity.
Effect Of Nursing Care Bundle on Outcomes for Women Undergoing Breast Surgeries
There is a significant differences improvements in total scores of knowledge level, practice pre and post-operative (after 4 weeks) after implementing nursing care bundle for women undergoing breast surgeries.


Inamed Silicone Breast Implant Core Study Results at 6 Years
Study results demonstrate the safety and effectiveness of Inamed silicone-filled breast implants through 6 years, including a low rupture rate and high satisfaction rate.
Two-year outcomes with a novel, double-lumen, saline-filled breast implant.
Two-year data from 472 women indicate that this double-lumen saline implant containing a baffle structure has a low rate of wrinkling and a lower rate of capsular contracture at 2 years than was reported for current single- lumen saline implants at 1 year.
Novel Approach for Maximizing Follow-Up in Cosmetic Surgery Clinical Trials: The Ideal Implant Core Trial Experience
This trial demonstrates the utility of a novel incentive strategy to maximize follow-up in cosmetic surgery patients and may benefit future cosmetic surgery trials and perhaps any prospective research trial by providing more complete data.
Validation of the Breast Evaluation Questionnaire for Use with Breast Surgery Patients
The Breast Evaluation Questionnaire is a 55-item assessment that was validated on 1244 women seeking augmentation mammaplasty and is recommended for assessing outcomes among breast augmentation patients, breast reconstruction patients, mastectomy patients, lumpectomy/breast-sparing surgery Patients, breast reduction patients, and patients who have sustained trauma or injury to their breasts.
The current supplement was submitted to expand the indications for use for the FoundationFocusTM CDxBRCA LOH for the detection of genomic loss of heterozygosity (LOH) to determine homologous recombination deficiency (HRD) status in ovarian cancer patients.
Directions for use: Product insert data sheet: Mentor MemoryGel silicone gel breast implants
  • Available at: Accessed August
  • 2017
Directions for use: Natrelle Silicone-Filled breast implants and Natrelle Inspira breast implants
  • Available at: https://allergan-web-cdn-prod.azureedge. net/actavis/actavis/media/allergan-pdf-documents/labeling/natrelleus/siliconeimplants/1034rev11.pdf. Accessed August
  • 2017
and Drug Administration
  • Guidance for industry and FDA staff: Saline, silicone gel, and alternative breast implants. Available at: medicaldevices/deviceregulationandguidance/guidancedocuments/ucm071233.pdf. Accessed August 15,
  • 2017
Government of Canada. Summary basis of decision: Mentor MemoryGel Silicone Gel-Filled breast implants: Health Canada
  • Directions for use: Natrelle Silicone-Filled breast implants and Natrelle Inspira breast implants. Available at