FDA Approves Sientra Implants for Breast Augmentation in the U.S.
Beverly Hills plastic surgeon Dr. Jay Calvert praises the arrival of Sientra’s portfolio of their Silimed-brand silicone breast implants, recently approved by the FDA in the United States. “This represents the displacement of the “two-company duopoly” that has existed in this country for more than 20 years, by offering surgeons and patients a new choice”, says Dr. Calvert. He notes that “other parts of the world have enjoyed strong competition, leading to innovation in implants and other breast implements. With this development, the United States may see a similar level of invention and progress.”
Unlike their two main competitors, Allergan and Mentor, these breast implants are available exclusively through board-certified plastic surgeons only, who espouse the safety and quality of the new breast devices.
The FDA-approved Sientra breast implants are the first and only company in the U.S. to provide a full portfolio of commercially-available breast implants, including shaped-implants in addition to standard round implants to best suit the variety of patients seeking augmentation or reconstruction. The board-certified surgeons who carry these implants can suggest the best match for a patient, based on body type, chest wall, and physical goals. Patients with a concave chest wall, a barrel chest, or scoliosis could benefit greatly from the selection. For example, the traditional round silicone implant would not be a good aesthetic match for some patients; instead, a high-projection round silicone gel implant could be preferable for those patients who need more projection in the upper breast and a wider expanse through the middle portion of the breast.
Adds Dr. Calvert: “It is important to note, however, that just because the devices are new on the market, they need to be carefully implemented in the USA. Sientra has been a powerhouse in other markets and has decades of data on safety of their implants, but it is always the surgeon’s job to evaluate new devices in their practice. Data is just that. Numbers and facts collected by the companies that support their case for sale of their device.” Dr. Calvert will evaluate these devices and use them IF they meet his standard for safety and results.
Among the decisions facing women undergoing breast augmentation or breast reduction surgery is picking between saline or silicone implants, as well as the size of the devices. This is best achieved after careful consultation with the plastic surgeon, who has the experience and training necessary to guide this call. As Dr. Calvert states on his website, he “strive[s] to produce an enhanced, natural look by balancing the capabilities of the surgical techniques with the woman’s desires. Since each woman is unique, each operation must be tailored to produce the best possible outcome for each patient.” The outcome is not solely related to a woman’s appearance; instead, it comes down to her confidence, self-image, and self-esteem.
In the same manner that Dr. Calvert’s expertise guides the patient to the best possible results from breast surgery, Sientra implants are made possible by the incorporation of techniques picked up from ASPS board certification and training. These are devices created by people who’ve been in the plastic surgeon’s office and in the operating room. They’ve talked to the women who request these devices, and they know how implants can affect a patient’s life after surgery. They also know that by offering exclusive use of Sientra through board-certified plastic surgeons, they are getting the best of all worlds: the best product development paired with the best real-world medical judgment. Allergan and Mentor, the leading competitors, also gained FDA approval for their implants, but they can’t claim the elite status of sole use by board-certified plastic surgeons.
Dr. Calvert himself saw the Sientra devices at the ASAPS meeting in Vancouver, Canada, and came away impressed. He remains hopeful that they fill a need in the breast reconstruction and augmentation market. Should you choose the Sientra devices, Dr. Calvert can address your questions on whether they’re the right fit for you.
Dr. Jay Calvert is a Board Certified Plastic Surgeon, certified by the American Board of Plastic Surgery. He practices in Beverly Hills, California and Orange County, California, where he performs all types of plastic surgery and specializes in cosmetic surgery. He has a special interest in face lifts, rhinoplasty (nose reshaping), and breast augmentation.
“Every person has their own vision of beauty. My goal is to develop a treatment plan designed to help each individual achieve their aesthetic goals in a safe and effective manner.”
To contact Dr. Calvert to see if Sientra is right for you, call RoxSpa Aesthetics to schedule your free consultation: 310.777.0496
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Written by Jane Emery





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