Innovative New Technology Saline Implant that Combines the Best Features of Saline and Silicone Breast Implants Scores Highly with Surgeons and Patients

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Houston Plastic Surgeon Dr. Henry Mentz Presents the Promising One-Year Results of Ideal Implant U.S. Clinical Trial to Texas Plastic Surgeons

A research study shows promising initial results for an innovative new saline breast implant that combines the best features of saline and silicone implants. Houston plastic surgeon Dr. Henry Mentz will present the one-year outcomes for the clinical trial of the Ideal saline breast implant at the Texas Society of Plastic Surgeons’ 2011 annual meeting in San Antonio, Texas. Mentz and his group at the Aesthetic Center for Plastic Surgery (ACPS) in Houston, Texas are one of 35 private practices chosen to participate in the implant’s 10-year U.S. clinical trial, in which 45 plastic surgeons certified by the American Board of Plastic Surgery took part. Of the 502 women enrolled in the study, 399 were first-time breast augmentation patients, and 103 had surgery to replace existing implants.

Results tabulated from the one-year follow-up visit of 478 patients showed the new implant scored well in both appearance and performance and had a high satisfaction rate among patients and physicians. Consisting of a series of shells of increasing size nested together, the Ideal implant was designed to minimize the most common disadvantages associated with saline implants: wrinkling of the shell and a less soft and natural feel compared to silicone gel-filled implants. The internal structure of the new implant supports its edges to reduce scalloping and control movement of the saline to prevent bouncing. In addition, the implant’s geometry allows it to contour more closely to the chest wall, to produce a more natural-appearing sloped taper compared to the more globular shape of current saline implants.

To demonstrate and compare features such as contouring to the chest wall and wrinkling of breast implants, upright MRI studies were performed on 18 women with various types of saline and silicone implants. Compared to current saline implants, the new implant produced a lower rate of wrinkling and capsular contracture − a condition which occurs when scar tissue that forms around the implant causes the breast to feel firm and, in some cases, develop an unnatural appearance. In addition, the new implant had no failures due to a fold-flaw of the shell, which is typically the cause of saline and silicone gel implant failures.

Patients responded favorably to the new implant; among those who were first-time breast implant recipients, 95 percent were satisfied with the outcome compared to 87.5 percent for those who had breast augmentation to replace existing implants. Surgeons gave the implant high marks as well, reporting a 96.3 percent satisfaction rate with the implant for primary breast augmentation cases and 89.6 percent when the implant was used to replace previous implants.

Dr. Mentz, whose group tracked the results of 39 patients, said, “I think it’s a good implant for patients interested in saline implants, especially if they’re lean patients. The shape is more beneficial, and the wrinkling issue is significantly reduced."

In 2010, breast augmentation was the most popular cosmetic plastic surgery procedure in the nation, with an estimated 318,000 procedures performed. Of these, 62 percent chose silicone implants, while 38 percent selected saline. Though silicone implants are more popular because of the natural look and feel they produce, many women feel that the benefits of saline implants outweigh those of silicone breast implants.

Saline implant ruptures cause the implant to deflate, making ruptures easy to detect, in contrast to silicone implants. Because silicone implant leaks are typically “silent,” MRI monitoring is recommended to detect any potential leaks. In addition, saline implants require a smaller incision during breast augmentation surgery compared to silicone implants because saline implants are inflated with saline after being inserted into the breast, whereas silicone implants are pre-filled.

Though studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that silicone breast implants are associated with cancer and connective tissue disease, some women choose saline implants because they feel it is a safer alternative than silicone implants.

If the new technology implant receives approval from the United States Food and Drug Administration, women may be able to have the best of both worlds: saline implants that have the more natural look and feel of silicone implants.

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