ATTENTION INAMED STYLE 153 GEL IMPLANT RECEPIENTS
INAMED STYLE 153 IMPLANT RECALL
The main reason for my letter is the change in the implant study you are or were participating in. Enclosed is a more formal statement from the Inamed company. It is quite complicated and cumbersome. For your convenience I enclose the statement we received from the company. Let me also give you my understanding of what is going on based on the explanation in the document and on the information provided to me by the company over the phone.
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.[1]
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.
Enclosed is a question and answer pamphlet that Inamed has provided and the FDA has reviewed to help address concerns you may have regarding this decision.
Information from Inamed Medical Products Corporation
for Patients with Style 153 Shaped Breast 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.
Why did I receive a letter regarding my breast implants?
This information is being provided to all women who have received McGhan Medical (now Inamed Medical Products) Style 153 silicone gel-filled breast implants, as investigational devices, in FDA-approved clinical trials. Inamed has decided to end the availability of the Style 153 implant.
Why is the Style 153 breast implant no longer available in the clinical trials?
Results from the Inamed Core Study show that the estimated rate of rupture in Style 153 implants is approximately 8% at 3 years. By comparison, the other implant styles in the Core Study had a rate of rupture of approximately 1% at 3 years.
Is my health at risk as a result of this new information?
No. We want to assure you that your health is not at an 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. Local symptoms due to rupture are rare and there are no known systemic health effects identified in women who have experienced rupture. The estimated rupture rates for the Style 153 implant 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-filled breast implants, which were approved for marketing in May 2000, have a rupture rate of approximately 5% to 6% at 3 years.
However, you should keep all follow-up appointments with your doctor as called for in your clinical study’s protocol, and talk with your doctor prior to such appointments if you are concerned about, or experience any change in, your breast health. Consultation with your doctor on a periodic basis and routine breast examinations are always recommended.
What exactly is a rupture?
It is important to understand what rupture means for silicone gel-filled breast implants. A rupture is a tear in the shell of your implant. Unlike a tear in a saline implant, a tear in a silicone implant does not necessarily cause the implant to deflate. As a result, the rupture may result in no symptoms and may not be detectable by you or your doctor by means of a physical exam; this is called an asymptomatic or silent rupture. However, other women may have what is called a symptomatic rupture, in which they may notice a change in breast size, nodules (lumps), uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning or changes in sensation.
Please keep in mind that breast implants are not lifetime devices and are not expected to last forever. Some may rupture in the first few months after implantation and some may rupture after several years or more. Therefore it is not possible to predict a rupture at any point in time for any individual patient for a given implant style
How will I know if my Style 153 implant has ruptured?
There is no completely reliable method to detect ruptures without surgically opening the pocket containing the implant. If you have a symptomatic rupture, you may notice a change in breast size, nodules (lumps), uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation. If you have an asymptomatic or silent rupture, there will be no symptoms. Clinical studies in the literature have shown that MRI is currently the most sensitive method for detecting silent rupture of silicone gel-filled implants. You should discuss with your doctor whether MRI screening is appropriate for you.
What if I want or need a replacement of my Style 153 implant(s)?
If, after consultation with your doctor, it is determined that you want or need replacement of your Style 153 implant(s), alternative breast implants are available. Your doctor can make a recommendation as to what alternatives are best for you. In addition, should your devices be determined to be ruptured, Inamed will honor its Confidence Plus product warranty, for lifetime product replacement, according to the warranty’s terms and conditions.
What should I do now?
Your continued participation in the Core or Adjunct Study is important. You should comply with all follow-up visits to your doctor as called for in the study protocol. If you are no longer participating in one of the Inamed studies please consult with your doctor. Consultation with your doctor on a periodic basis and routine breast examination are always recommended. Your doctor can discuss monitoring plans with you, including MRI screening and other diagnostic tests that may determine whether your implants have ruptured.
First of all, there is no reason to panic. What this means is that Inamed Medical company determined that the style 153 implant was not as durable as they planned. At 3-year mark most implants have the rupture rate of 1%. Their study showed that the implant style 153 had a rate of 8% in the same 3-year period. Based on that data the company discussed the result with FDA and decided to stop the use of style 153 implant.
It does not mean that you are in any danger. It does not mean that there are adverse results of silicone or the implant. All it means is that the implant that you have is not as durable as the company originally thought. It also means that the risk of rupture of the implant is greater and I would advise you to continue with your follow-up visits as scheduled. If you have not been examined for a while, please, make you appointment at your earliest convenience.
There are only 2 ways to determine if your implant had ruptured: MRI or surgery. Unfortunately, there are no other tests to determine that. Breast ultrasound is not very reliable. If you would like to know if your implant is ruptured, the first step is to come for an appointment and exam. If there is a suspicion of the rupture, we will direct you to the MRI facility.
If your implant is not ruptured, you have several options: one is to keep them in and come for routine check ups either to our office or other participating plastic surgeon (other surgeon would have to request all the records from our office). Again there is no documented damage from silicone and current company recommendations are to keep routine visits. Another option is to have the implants replaced with new ones. Unfortunately, it comes at additional cost. The implant warrantee insurance provided by the Inamed DOES NOT COVER replacement of intact implants.
If your implant is ruptured, as documented by MRI, then the implant needs to be replaced. The options include either another silicone implant or a saline implant. The complexity of this scenario is that the company does not provide the same style 153 implants any longer. Therefore, in the replacement we have to use another implant.
At this time we could not receive the answer to the following question. If only one implant is ruptured and then replaced with a similar (but not the same) one, it means that the woman will end up with 2 different breast implants. This may mean that the breasts may look somewhat different after the surgery on one side only. They do not plan on covering the other side replacement with a matching implant at this time but they expressed the willingness to consider individual cases.
The coverage of replacement does not mean that they pay for it. Most implants are covered with basic warrantee that covers ONLY ruptured implant and provides $1200.00 toward surgical services. In this case ONLY ruptured implant is replaced, there is no warrantee covering another side. There is also a more advanced warrantee plan, which should have been purchased at the time of original surgery, and it covers BOTH implants, ruptured and intact, and provides $2400.00 toward surgical services. What all this means is that your final out of pocket costs may depend on the type of warrantee you have.
Let me emphasize again that the purpose of this letter is to inform you about withdrawal of the style 153 from the market due to higher then expected rupture rates. I encourage you to make an appointment with my office to have your breasts examined and to discuss any additional concerns you might have. My staff will not be able to discuss all the particulars of this matter over the phone as it depends on your individual case.
Sincerely,
Boris Volshteyn MD MS
Plastic and Reconstructive Surgery
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[1] Refer to FDA’s breast implant website (http://www.fda.gov/cdrh/breastimplants/) for additional information regarding the April 2005 Panel meeting.