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Dr. Adams helps explain: "What is the current status of breast implants?"I have been asked by many patient to clarify the current status of breast implants. This is indeed a confusing subject and current regulatory politics have further clouded the issue.
Saline breast implants were approved by the FDA in 2000. Silicone gel breast implants are still in the approval process. Since 1992 the only availability of silicone gel implants has been thru the silicone gel adjunct study which made these devices available to breast reconstruction patients, women with pre-existing gel implants for revision and breast augmentation / breast enlargement patients who have saline implant problems or are deemed poor candidates for saline implants. In the late 1990s the 2 main breast implant companies (Mentor and Mcghan (later Inamed and now Allergan Medical) began their core gel PMA (pre-market approval) FDA studies on silicone gel implants to determine the safety and efficacy of these devices. Inamed Corporation finished their study 1st and went to a FDA panel hearing in October 2003 where they received a vote for approval by the panel. In January of 2004 the FDA made an uncharacteristic decision to deem the Inamed implants "not approvable" without further information. Subsequently, Inamed and Mentor Corporations went to another FDA panel hearing in April 2005. In a strange sequence of event Inamed received a 5-4 vote against approval and the next day Mentor received a 7-2 vote for approval. The Inamed issues surrounded one type of silicone gel implant (style 153) that had much larger rupture rates that their standard round devices. That summer Mentor Corp. received an "approvable letter" from the FDA that states the devices are deemed worthy for approval once certain conditions are met. Concurrently, Inamed discontinued the style 153 implant and amended their PMA and at the end of the summer 2005 also received a similar approvable letter from the FDA. Generally the companies will work with the FDA on these conditions and usually device approval is expected within 6 months. It has now been 15 months and we are still in a holding pattern waiting on the full silicone gel device approval. Many factors have contributed to this extended delay - politics leading the way; however, many of us feel things are very close for the much anticipated approval. Also it is important to understand that the devices up for imminent approval are the non-form stable round silicone gel implants. There are another generation of implants that are called cohesive gel implants or gummy-bear implants. These implants have more highly cross-linked filler and are much more form stable offering many benefits to patients that are supported by their study data. These implants have undergone their FDA PMA clinical trials, but their approval process has been put on the back burner by the delays with the older gel implant approval (outlined above). It is also important to realize breast implants exist in a variety of forms. My nanny was watching Dr. 90210 last week and I happened to walk thru the room and hear a surgeon explaining to a patient that the implant are not liquid silicone but more solid as the patient was shown a marketing ad used by a breast implant manufacturer. I have observed real confusion on the part of both patients and surgeons as I have presented to plastic surgeons, medical professionals and patients across the country. The result of this confusion is a plethora of "half truths" about various breast implants being conveyed to patients. Breast implants should be characterized by their individual characteristics as they are all different. Terms such as "liquid silicone" or "solid silicone" and many current marketing campaigns lead to patient confusion. What I can tell you is that the implants that are currently up for approval are very similar to the 3rd generation implants (see implant generation article Spring 2006) that were being used at he time of the silicone gel implant moratorium in 1992. The 2nd generation implant of the 1980's had less cross-linked filler; however, were far from liquid. The 3rd generation (and current) 4th generation have a "thicker" more cross linked filler; however are far from a solid. The newest 5th generation cohesive gel / gummy-bear implants have the most cross-linked filler and are the most form stable. In the end there will likely be many more available breast implant choices for patients in the coming year. It will be important for both patients and surgeons to remember that all implants should be assessed/ judged on their individual characteristics and not on generalizations that lead to confusion. William P. Adams, Jr., MD |
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