IDEAL IMPLANT Structured Breast Implants

Core Study Results at 6 Years

Larry S. Nichter, M.D.; Robert A. Hardesty, M.D.; Gregg M. Anigian, M.D.

Disclosures

Plast Reconstr Surg. 2018;142(1):66-75. 

In This Article

Abstract and Introduction

Abstract

Background: The structured breast implant uses different technology than saline or silicone gel implants, making it a third type of implant. The U.S. Food and Drug Administration and Health Canada granted approval in November of 2014. This implant is filled with saline but has an internal structure consisting of a series of nested shells that support the upper pole when upright and control fluid movement. It combines certain key features and benefits of saline and silicone gel implants. As with saline, the filler is only saline, which women like for peace of mind in case of rupture/deflation. As with silicone gel, it has a natural feel, but without the risk of silent rupture and U.S. Food and Drug Administration–recommended magnetic resonance imaging scans—women can simply look in the mirror and know their implants are intact.

Methods: This U.S. trial enrolled 502 women: 399 primary augmentations and 103 replacements of existing augmentation implants. Investigators were 45 American Board of Plastic Surgery–certified plastic surgeons at 35 sites. Of the 502 women enrolled, 438 (87.3 percent) completed 6-year follow-up visits, a higher percentage than other Core breast implant trials.

Results: At 6 years, patient satisfaction was 89.7 percent for primary and 91.6 percent for replacement augmentations; surgeon satisfaction was 92.6 percent for primary and 94.0 percent for replacement augmentation. Kaplan-Meier adverse event rates were as follows: Baker grade III and IV capsular contracture, 5.7 percent for primary and 11.5 percent for replacement augmentation; and rupture/deflation, 1.8 percent for primary and 4.7 percent for replacement augmentation.

Conclusion: Six-year results from 438 women show that the structured breast implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation.

Introduction

The IDEAL IMPLANT (structured breast implant) was approved by the U.S. Food and Drug Administration and Health Canada in November of 2014. Previously, women had the choice of two types of implants: saline (an unsupported silicone elastomer balloon filled with saline) or silicone gel (a silicone elastomer balloon filled with silicone gel). Each of these implant types has certain well-known advantages and disadvantages.

The saline implant does not have a natural feel because movement of the saline filler is uncontrolled, allowing rapid displacement with motion. Because the implant shell is unsupported, the upper pole collapses when upright and the shell tends to wrinkle (Figure 1, above, left). However, the advantage of the saline implant is that the filler is saline, which gives women peace of mind. In case of a rupture (deflation), the implant gets smaller as the saline is harmlessly absorbed by the body; thus, a woman can simply look in the mirror to know whether her implants are intact or ruptured.

Figure 1.

(Above, left) Mentor Moderate Plus 325 cc saline implant at minimum fill volume (total implant volume, 345 cc from 325-cc fill volume plus 20-cc empty implant volume). (Above, center) Allergan Moderate style 15 silicone gel implant (total implant volume, 339 cc). (Above, right) Allergan Inspira style SRF silicone gel implant (total implant volume, 365 cc). (Center, left) Allergan Inspira style SSF silicone gel implant (total implant volume, 365 cc). (Center, center) Allergan Inspira style SCF silicone gel implant (total implant volume, 365 cc). (Center, right) IDEAL IMPLANT 335-cc structured implant at minimum fill volume (total implant volume, 335 cc). (Below) A 335-cc structured IDEAL IMPLANT at maximum fill volume (total implant volume, 375 cc). Standardized oblique photographs were taken perpendicular to the surface of a curved form with a 10-inch diameter that simulates the convexity of the chest wall. The form was tilted 45 degrees up from the horizontal; a 2-cm lip at the bottom of the form kept the implant from sliding off and simulates support from the inferior capsule. (Photographs courtesy of Ideal Implant Incorporated.)

The silicone gel implant has a natural feel because the viscosity of the silicone gel filler mimics breast tissue. The cross-linked silicone gel supports the implant shell, so there is less upper pole collapse when upright and less wrinkling compared with the saline implant (Figure 1, above, center). Increasing the silicone gel fill to 95 percent without increasing the cross-linking increases support for the implant shell; thus, there is even less upper pole collapse when upright (Figure 1, above, right). Progressive increases in cross-linking at the same 95 percent fill (Figure 1, center, left and center, center) further increase support for the implant shell, further reducing upper pole collapse when upright. The disadvantage of the silicone gel implant is that ruptures are silent (i.e., not clinically detectable), and occur at a relatively high rate (9.3 to 24.2 percent in 10-year Core studies[1,2]), which concerns many women. The U.S. Food and Drug Administration recommends a magnetic resonance imaging scan to detect rupture at 3 years after implantation and then every 2 years for life. Also, the U.S. Food and Drug Administration recommends removal of a ruptured silicone gel implant, which may entail additional time-consuming procedures such as capsulectomy for complete removal of the silicone gel. The IDEAL IMPLANT was designed to combine the peace of mind of the saline implant and the natural feel of the silicone gel implant, without the drawbacks that concern women most (i.e., unnatural feel of the saline implant and silent rupture of the silicone gel implant).

This implant is named a "structured" implant because of its internal structure, which supports the shell so there is less upper pole collapse when upright and less wrinkling compared to round saline and certain round silicone gel implants (Figure 1, center, right). Increasing the fill volume in the outer lumen of the structured implant increases support for the shell, so there is even less upper pole collapse when upright (Figure 1, below). Since its unique design and technology are different from saline and silicone gel implants, the structured implant is a third type of breast implant. Classifying breast implants on the basis of their saline or silicone gel filler material fails to identify differences in shell support that affect implant performance. A more informative classification is proposed here: "unsupported shell" (saline implant) or "supported shell" (silicone gel and structured implants).

The IDEAL IMPLANT is a round, smooth-surface, saline-filled implant with an internal structure. It has two lumens within two nested shells that are attached at the patch on the back. The inner lumen within the inner shell is filled through a valve in the patch with approximately two-thirds of the saline. The outer lumen within the outer shell, and surrounding the inner shell, is filled through a valve on the front with approximately one-third of the saline. Unattached and floating within the outer lumen is a baffle structure designed to restrict movement of the saline in the outer lumen. This internal structure is composed of one to three nested baffle shells that are perforated with slits so the saline is free to move through the slits, and around and between the shells. The number of baffle shells in an implant is proportionate to the size: 210- to 300-cc implants have one baffle shell, 335- to 555-cc implants have two baffle shells, and 595- to 675-cc implants have three baffle shells. A cutaway drawing (Figure 2) of an IDEAL IMPLANT (335- to 555-cc) shows the inner shell, the outer shell, the baffle structure floating in the outer lumen composed of two baffle shells perforated with slits, the valve in the patch to fill the inner lumen, and the valve on the front to fill the outer lumen. The shape of this round implant was designed with the edge low, to contour to the convexity of the chest wall, and tapering from the dome to the edge so that the side of the implant does not bulge outward toward the arm (Figure 3).

Figure 2.

Cutaway of IDEAL implant (335- to 555-cc) to show internal structure. (Drawing courtesy of IDEAL IMPLANT Incorporated.)

Figure 3.

IDEAL implant on a curved surface simulating the convexity of the chest wall. (Photograph courtesy of IDEAL IMPLANT Incorporated.)

Overfilling, a common practice for some surgeons using a saline implant, is not needed or recommended for the structured implant. For all 14 implant sizes, inner lumen fill volumes were engineered to be the same percentage of the inner shell mandrel volume, and are not adjustable. The outer lumen fill volumes are adjustable within a range that is proportionate to the implant size, from a range of 25 cc for the smallest size to a range of 80 cc for the largest size (Table 1). The minimum and maximum outer lumen fill volumes were engineered so that each is the same percentage of the outer shell mandrel volume. Because of this design, all implant sizes have the same shape and contour when at the minimum fill volume and when at the maximum fill volume.

The diameter and projection of the implant were measured on a convex surface simulating the curve of the chest wall (Figure 3 and Table 1), instead of on a flat surface as done by other manufacturers. This difference in measurement methods should be considered when comparing dimensions of the structured implant to other implants. For example, the diameter of a 210-cc implant at minimum fill volume measures 3 mm less on a curved surface than when measured on a flat surface. Similarly, the diameter of a 675-cc implant at minimum fill volume measures 7 mm less on a curved surface than when measured on a flat surface. The same adjustment applies to projection measurements: a 210-cc implant at minimum fill volume projects 3 mm more on a convex surface than when measured on a flat surface; and the projection of a 675-cc implant at minimum fill volume projects 7 mm more on a convex surface than when measured on a flat surface.

The total implant volume comprises the empty implant volume plus the saline volume added to each lumen. If either lumen deflates, considerable implant volume remains to maintain much of the breast augmentation. Nevertheless, the deflation of either lumen is obvious to a patient by looking in the mirror, and replacement can be scheduled electively.

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