The main reason for this page is the change in the implant study you are or were participating in.
You are currently participating, or have participated, in a Food and Drug Administration-approved, investigational device clinical study called the Inamed Adjunct Study or Inamed Core Study for silicone gel-filled breast implants. This is to give you a progress report on the silicone gel-filled breast implant study in which you are (or have been) enrolled, and to let you know the status of the Style 153 implants which you received.
As you know, silicone gel-filled breast implants have been the subject of many studies in recent years. The study that you are or were enrolled in was designed to collect clinical data, in particular the complications, associated with certain McGhan Medical (now Inamed Medical) silicone gel-filled breast implants, including the Style 153 implant you received. Interim data from the Inamed Core Study have now been analyzed, and I want to share with you some of the interim data reported for the Style 153 implants and the other implants in the study. These data were presented and discussed at the April 2005 FDA Advisory Panel meeting.
Results from the Inamed Core Study show that the estimated rate of rupture in the Style 153 implants is approximately 8% at 3 years (or 8 out of 100 implants). The rate of rupture for the other implant styles in the Core Study is approximately 1% (or 1 out of 100 implants by 3 years). These rates obtained from the Core Study are consistent with the “Risks, Complications and Discomforts” section of the patient informed consent form you signed when you entered the study. In comparison, Inamed’s saline implants, which were approved by the FDA for marketing in May 2000, have a rupture rate of approximately 5% to 6% at 3 years.
Inamed has decided, after consultation with the FDA, to end the availability of the Style 153 breast implant as an investigational device in the Inamed Adjunct Study and Inamed Core Study. Inamed will continue to monitor and collect data from all Style 153 patients through the conclusion of the studies.
The decision to end the availability of this investigational device does not mean there is any new health concern about this implant, other silicone gel-filled breast implants, or saline-filled breast implants. We want to assure you that your health is not at increased risk based on these findings. In fact, the vast majority of women who have received the Style 153 implants are satisfied with their implants.
Inamed is providing this information to assist in answering possible questions you may have about your Style 153 breast implant and recent results from the Inamed Core Study. Although this information has been reviewed by FDA, it is not intended as a substitute for your doctor’s professional judgment and recommendations.