The FDA announced on February 20, 2013 the approval of the Allergan style 410 highly cohesive gel implant

 Patients will no longer need to be enrolled in a clinical study to be able to get an Allergan style 410 highly cohesive silicone gel implant

The use of shaped highly cohesive gel breast implants is a technically demanding procedure and women should seek out a board certified plastic surgeon with extensive experience with these newer generation devices

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Dr Glicksman is among a select few plastic surgeons in the United States currently enrolling patients in two FDA approved clinical trials. Both of these 10 year follow-up studies allow women the use of the newest generation of silicone gel implants.

The form stable highly cohesive gel implants, also known as “Gummy Bear” implants, are available for women seeking:

Highly cohesive breast implants that are X or L styles remain at this time investigational devices and are not yet approved by the FDA. Patients will need to enroll and meet the eligibility criteria for the study. The FM, FF, MM, and MF styles no longer require study enrollment

  • Breast augmentation
  • Breast reconstruction and revision breast augmentation

Availability and enrollment is limited and patients are responsible for costs of the procedure. Patients will not be charged for their annual follow-up visits, which is mandatory for acceptance in the 10 year study.

Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

  • Be a female 18 years of age or older,
  • Have a condition appropriate for breast augmentation, reconstruction or revision
  • Have adequate tissue available to cover the implant(s),
  • Complete a screening by your surgeon,
  • Is willing to sign informed consent document which gives you information about your breast implants and confirms your commitment to follow study requirements and acceptance of the potential risks involved.
  • Is willing to have a magnetic resonance imaging procedure (MRI) performed immediately prior to explantation, if medically advisable.

Exclusion Criteria

  • Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
  • Existing carcinoma of the breast, without mastectomy.
  • Abscess or infection in the body at the time of enrollment.
  • Pregnant or nursing.
  • Have any disease, including uncontrolled diabetes (e.g., Hb AIc > 8%), that is clinically known to impact wound healing ability.
  • Show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration.
  • Have, or under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems).
  • Show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder).

Patients interested in enrollment should Contact Us

For more information on the form stable cohesive gel implants: