Cohesive Gel Implants and Studies
Dr. John Lettieri is one of a few select surgeons nationwide who was selected and has been participating in long-term studies for both Allergan’s Inamed Cohesive Gel breast implants and Mentor’s CPG breast implants. Dr. Lettieri was the only surgeon in South Carolina to be admitted to the Allergan study, and allowed to use the implants for his patients, and he is one of a select few surgeons nationwide who are involved in the Mentor study. Dr. Lettieri is also well published in several major medical journals on the topic of breast surgeries and implants. Because of his expertise – he has been involved in virtually all available breast implant programs. This in turn has afforded his patients many breast implant options for cosmetic and reconstructive surgeries.
Studies are important for both physicians and patients for several reasons. Studies prove the safety and effectiveness of a product while enlightening researchers/developers as to strengths and weaknesses and - what’s liked and what’s not. Studies dispel myths and produce accurate information which is then used to educate people about the proven benefits of a product.
Dr. John Lettieri is a well known, highly respected expert in all surgeries of the breast. He is a pioneer among surgeons who has researched and studied breast implants – in order to bring his patients the best –
world class products available today.
To be selected for study participation and implant use for patients - a surgeon must:
1) Have a proven history of surgical expertise
2) Be committed to careful patient follow-up
On November 17, 2006, the FDA approved silicone gel implants because the products have been proven to be safe and effective. The FDA will continue to monitor them through large post-approval studies, which now involve about 40,000 women nationwide. Patients will be followed closely for 10 years after implantation.
Implants will be used for the following three surgeries: 1) breast reconstruction; 2) breast augmentation, 3) breast revision surgery – to replace old saline implants with new high-tech gel implants or to replace old gel implants with new gel implants.
CRITERIA FOR BEING ACCEPTED INTO A STUDY PROGRAM:
- Must be a female 18 years of age or older
- Must have a condition appropriate for breast augmentation, reconstruction or revision surgery
- Must have adequate breast tissue to cover the implant(s)
- Must complete a screening by Dr. Lettieri and be willing to sign Informed Consent document which provides all information about the breast implants and confirms your commitment to follow study requirements and acceptance of the potential risks involved.
- Must be willing to have a magnetic resonance imaging procedure (MRI) performed immediately prior to explantation, if medically advisable.
- Must live within a reasonable geographic distance from Dr. Lettieri’s office(s).
After your implantation, the study schedule requires follow-up visits each year for 10 years after your surgery. During each follow-up visit you will complete Case Report Forms on Quality of Life and Activity and Lifestyles. Photographs of the breast/chest area will be taken prior to your surgery and one year after surgery.
- Patients with certain medical problems will not be able to participate.
MAIN BENEFITS OF COHESIVE GEL IMPLANTS INCLUDE:
- Cohesive gel implants offer longevity & desirable shape
- They do not develop folds – so they do not fail
- Given the rare instance a fold occurs – the gel will not migrate
- Cohesive gel implants are anatomically shaped to naturally feather into the upper chest – making it less conspicuous
- Cohesive gel implants come with smooth or textured surfaces
- There have been many studies done with no linkage to any type of illness
In the many studies completed over the many years of silicone usage – the satisfaction rate has remained in the high 90’s – especially for breast implant studies. It has been proven that women benefit not only physically – but emotionally as well.
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