The FDA Just Approved a New Breast Implant

Updated January 3, 2017

Allergan announced today that it has received approval from the FDA to market the implants. 

"Adding Natrelle Inspira SoftTouch breast implants to our already robust line of offerings gives Allergan the most extensive variety of implants in the industry and provides doctors with a wide range of options," David Nicholson, chief R&D officer of Allergan, said in a statement. "Now, the Inspira line of breast implants helps physicians to better meet diverse, patient-specific needs based on available breast tissue and desired outcomes. We're delighted to have this offering available in the U.S. since they are so popular with doctors and patients internationally."

Originally published September 28, 2016

Allergan got the FDA’s pre-market approval on a new line of breast implants last week. According to the company, the Natrelle Inspira cohesive breast implants give a new breast shaping option that combines a high gel-fill ratio and Allergan's highly cohesive gel for a customized result.

“Natrelle Inspira cohesive breast implants are just the latest example of our commitment to innovation in breast aesthetics and plastic surgery, and we are proud that we are able to continue to offer advancements in technology that allow physicians and their patients more options. Natrelle Inspira cohesive allows patients to get the same high gel-fill ratio and fullness offered by the Natrelle Inspira line of implants, with our highly cohesive, form-stable gel,” chief R&D officer David Nicholson said in a release.

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Basically, this new implant will be an addition to the overarching category of “gummy” implants, designed for women who are interested in increased breast fullness. “Having a more cohesive gel-fill helps silicone breast implants maintain their shape and reduces the risk of rippling and irregularities,” explains Paradise Valley, AZ, plastic surgeon Robert Cohen, MD. “Increased cohesion also enhances an implant's ability to resist compression from overlying tissues, giving surgeons more power to transform breasts into the final desired shape and size. Finally, increased cohesion is beneficial in the event of an implant rupture, as it minimizes gel migration and distortion.”

Dr. Cohen says, in his opinion, this trend is only positive. “More choices means more tools for surgeons to help their patients achieve the best possible result. Not every patient needs this type of implant, but for patients interested in smooth, round implants that are at higher risk for rippling due to thin tissues, or patients with constricted lower breasts that need lower pole expansion, these implants will offer an advancement over previous generations of implants.”

But Scottsdale, AZ, plastic surgeon Patti Flint, MD, says she isn’t totally on board with the new introduction. “Regarding highly cohesive implants, I do not use them because I am very pleased with the results I obtain with round smooth implants. Many highly cohesive implants are textured because they are shaped. Recent studies have shown that even plastic surgeons cannot tell the difference when reviewing pre- and post-op photos as to which patients had shaped implants and which didn't.”

“I don't believe the added costs or in some cases added firmness is worth it,” she adds. “The upsides really aren't there for me. For breast cancer patients, I do feel this type of implant can provide some benefit in some cases. You will find these implants are very popular, however, because of media buzz, as well as a possibility that capsular contracture rates are lower with textured implants.”

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1 Comment
  • Donna
    Posted on

    The FDA recently announced that textured implants increase the patient's chances of ALCL by 400X. It's probably worse because it takes a miracle for the FDA to post data about medical devices. I had texturned implants (Allergan 410s which are the anatomical gummy bear implants) which were hard like a rock and uncomfortable. I had them for 3 years and 4 months. They did not look good and I am a tall woman. Yesterday, I had an implant revision with Allergan Inspira Implants along with fat grafting. I have Inframmary Incisions which are under the breast. I had a nipple sparing prophlactic bilateral mastectomy 3 1/2 years ago due to my genetic mutation and being a breast cancer survivor with a prior lumpectomy. I would never put implants into my body if I didn't have a mastectomy. Women do not replace implants in a timely manner. This is an expensive reoccurring expense that women put off. Even women who can afford to replace their breast implants, do not do so as Wendy Willams. For the record, I do love the 'how ya doin' host"!! Regarding my comments about the FDA, the FDA has basically granted this medical device immunity from class action lawsuits for Endometrial Ablation aka NovaSure for women with heavy menstrual cycles. Hologic, the manufacturer spends millions of dollars on advertising geared at gynecologists. Ablation is misused and the company doesn't answer patient questions. I admin a Novasure Facebook Site detailing information about the procedure and what you were probably not informed about and so much more. If you want to read horror stories about NovaSure as well as other ablation procedures, as a female, you can join this group. Medical doctors are invited as well. "NovaSure & What You Should Know" is the name of the Facebook group. We would love for a law firm to take on this case but NovaSure is a Class III Medical Device which is given protection from class action lawsuits thanks to the FDA. I've contacted Hologic many times and even if someone says that I will receive feedback, it never happens. It's great being a woman!

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