Goals/Purpose: Wrinkling or scalloping is a well-known problem with current saline implants, keeping some women from choosing them. To minimize this problem, a new technology implant was developed consisting of a series of shells of increasing size nested together. The inner shell defines the inner lumen, the outer shell the outer lumen. Within the outer lumen are one to three unattached perforated shells. The purpose of this internal structure is to control movement of the saline filler to prevent bouncing, support the upper pole to prevent collapse when upright and support the edges to minimize wrinkling and scalloping. Also beneficial is the implant geometry, designed so the peripheral edges would be lower and contour closer to the chest wall. Outcomes at 1-year in 130 women are reported.
Upright MRI studies were used to demonstrate and compare contouring to the chest wall and wrinkling of breast implants.
Methods/Technique: A 10-year US clinical trial seeking Premarket Approval (PMA) started February 2009. A total of 502 women were enrolled by February 2010 at 35 private practice sites by 45 ABPS certified plastic surgeons, 400 for primary breast augmentation and 102 for replacement of existing augmentation implants. To date, 487 of the 502 women enrolled are completing all their follow-up visits, a 97% follow-up rate. Clinical data from the 1-year follow-up visits of 130 women seen through October 26, 2010 was available and tabulated by the Clinical Research Organization as a percentage of the women in each cohort, 97 primary augmentations and 33 implant replacements.
Upright MRI studies were performed in 18 women with various types of saline and silicone gel implants. All were at least 1-year post-operative and none had capsule contracture. Axial views showed implant edge contouring to the chest wall and coronal views of the implant, both inferiorly and laterally, showed wrinkles or scallops. Five women had Upright MRI studies of current saline implants and then of replacement new technology implants, allowing side-by-side comparisons.
Results/Complications: Patient reported satisfaction with the outcome was 99.0% for augmentation and 97.0% for replacement. Surgeon reported satisfaction was 96.9% for augmentation and 100% for replacement. The table below compares 1-year adverse event data to the 1-year Large Simple Trial (LST) data used in the PMA applications for the current saline implants. Allergan had a 1-year follow-up rate of 62%; Mentor had a 1-year follow-up rate of 47%. (LST wrinkling data was not available at 1-year; therefore 3-year wrinkling data is shown in the table.)
Deflation data through October 26, 2010 for all 502 women in the trial was tabulated as a percentage of the women in each cohort and is shown in the table below. There have been no deflations due to shell failure caused by a shell fold. One deflation was due to iatrogenic shell failure from puncture by a surgical needle. Deflations due to posterior valve failure were caused by initial assembly problems that were identified and corrected early during manufacturing of the clinical trial implants.
Subjective comments from patients and investigators were positive about shape, contour to the chest wall, lack of bouncing and natural feel.
Comparison of Upright MRI views demonstrated the new technology implants contour better to the chest wall with the implant edge lower than current saline implants. Also, the new technology implants had a more gradual taper toward the dome area and were not as globular as comparison saline implants. Wrinkling seen with current saline implants was reduced with the replacement new technology implants.
Conclusion: Deflation data from all 502 trial patients and 1-year clinical data from 130 patients indicates that this investigational new technology saline implant has a lower rate of wrinkling, capsule contracture and deflation from shell failure than the current standard saline implants. Outcome satisfaction is very high for both patient and surgeon.
Table 1. Percentage of Saline Implant Complications
|
Primary Augmentation |
Implant Replacement |
||||
IDEAL |
Allergan |
Mentor |
IDEAL |
Allergan |
Mentor |
|
Wrinkling – none/negligible |
91.8 |
no data |
79 |
75.8 |
no data |
85 |
Wrinkling - mild |
3.1 |
no data |
21 |
15.2 |
no data |
15 |
Wrinkling - moderate |
4.1 |
10.5 |
9.1 |
|||
Wrinkling - moderate/severe |
1.0 |
0 |
||||
Wrinkling - severe |
0 |
0 |
||||
Capsule contracture - Baker 3 & 4 |
1.0 |
7.2 |
5 |
0 |
11.8 |
15 |
Infection |
1.0 |
1.5 |
1 |
0 |
3.3 |
no data |
Removal - with/without replacement |
8.2 |
6.1 |
4 |
3.0 |
7.8 |
6 |
Deflation - shell failure |
0.2 |
3.6 |
1 |
0 |
5.4 |
2 |
- anterior valve failure |
0 |
0 |
||||
- posterior valve failure |
3.0 |
1.0 |
||||
