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IDEAL Implant Tops List of “Biggest Beauty Breakthroughs” of 2015

December 9, 2015

The IDEAL IMPLANT is among the FDA-approved breast augmentation options that select plastic surgeons in New York City offer women. Though popular, silicone gel implants pose risk of ruptures, which can be detected only with an MRI scan. While saline implants are considered safer because ruptures are easier to detect and the saline solution is absorbed by the body, the downside is that they don’t look or feel very natural. Years of research and testing to find an alternative that would overcome these issues led to the development of the IDEAL implant – a saline-filled structured breast implant made of safe, proven material that offers a natural feel. It’s little wonder that IDEAL implant got top-ranking in a Yahoo Beauty article listing the biggest beauty breakthroughs of 2015 that are transforming the beauty world.

“Beauty without compromise” is certainly the right way to describe this new implant. It combines the best features of its counterparts, offering the natural feel of a silicone gel implant with only saline inside. Women can enjoy safety and peace of mind with the IDEAL implant, as they no longer need to have regular screenings to detect ruptures – just a glance in the mirror would tell them if their implant is intact or has ruptured.

The innovative design of the new structured implant comprises a series of shells nested together and two separate chambers to hold the saline filler. The internal structure controls movement of the saline and is designed to reduce the risks of folding, wrinkling, deflation, rupture and capsular contracture.

The FDA approved the IDEAL implant in November 2014 based on the safety profile positive results of a five-year U.S. clinical trial that included more than 500 women who had the IDEAL IMPLANT for primary breast augmentation or replacement of existing augmentation implants. The results of the clinical trial are as follows:

IDEAL IMPLANT 5-Year Follow-up
445/502 Patients = 88.6%
  PRIMARY REPLACEMENT
Surgeon Satisfaction with Outcome 93.9% 91.7%
Patient Satisfaction with Outcome 91.9 92.9
Infection 1.3 1.0
Deflation
(includes implants with early mfg. defects)		 13.1 16.7
Wrinkling
(moderate – severe)		 7.3 16.2
Capsule Contracture (Baker 3 & 4) 5.7 10.4

Deflation / Rupture (MRI Cohort)
FDA trial data
  PRIMARY REPLACEMENT
IDEAL IMPLANT 5 year
excludes implants with early mfg. defects)		 1.8% 3.5%
Allergan Saline 5 year 6.8 No data
Mentor Saline 5 year 9.7 No data
Allergan Gel 6 year 5.5 2.3
Mentor Gel 6 year 3.4 7.2
Sientra Gel 5 year 4.2 2.8

Capsule Contracture Rates – Baker 3 & 4
FDA trial data
  PRIMARY REPLACEMENT
IDEAL IMPLANT 5 year 5.7% 10.4%
Allergan Saline 5 year 11.4 No data
Mentor Saline 5 year 10.1 No data
Allergan Gel 6 year 14.8 20.5
Mentor Gel 6 year 9.8 22.1
Sientra Gel 5 year 8.8 7.9

The IDEAL implant is available in 14 different sizes. It is approved for breast augmentation in women at least 18 years old for primary augmentation to increase the breast size, as well as to correct or improve the result of a primary breast augmentation surgery.

Only a select group of plastic surgeons in the U.S. and Canada are authorized to offer the IDEAL implant. Choosing a surgeon who is an expert in breast implant surgery would provide the best results.