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Misleading Malrotation of the Natrelle Style 510 Prosthesis

Riggio, Egidio M.D.

Plastic and Reconstructive Surgery: April 2011 - Volume 127 - Issue 4 - p 1738-1740
doi: 10.1097/PRS.0b013e31820a668e
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Unit of Plastic and Reconstructive Surgery; Fondazione Istituto Nazionale Tumori; Via Venezian, 1; 20133 Milano, Italy; egidio.riggio@istitutotumori.mi.it

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Sir:

I read the article by Schots et al. entitled “Malrotation of the McGhan Style 510 prosthesis.”1 I have been using anatomical implants for 16 years and the extra-projection dual-gel 510 type implant manufactured by Allergan for 6 years.2,3 Malrotation occurred exceptionally. I recently wrote a chapter treating the overall features of 510 implant insertion, and it will soon be freely available online by means of download.4 A consecutive series of 55 breast augmentations (110 prostheses) was reported essentially adopting a dual-plane–like approach. The mean age of the patients was 33.5 years (range, 18 to 52 years), mean follow-up was 12.5 months (range, 6 to 48 months), and mean implant weight was 350 g, (range, 155 to 495 g). Unilateral malrotation was recorded for one patient 6 months after secondary surgery (i.e., implant substitution with full-height 510FX 310-g prosthesis), which requires surgical correction. In another secondary case with secondary pexy plus submuscular substitution (full-height, 350 g), I observed some unilateral malrotation that the patient herself had never recognized (31 months' follow-up) (Fig. 1). In contrast, none with primary augmentation complained except for one. A patient with full-height 435-g prostheses described to me sporadic displacement with spontaneous rotation in the orthotopic position. Schots calls it “dynamic rotation.”1 This occurred after 2 years in a large breast with hypoelastic skin and moderate ptosis; the follow-up has been ongoing for 5 years and has revealed some breast asymmetry without displacement, and the patient's results are still satisfactory.

Fig. 1.

Fig. 1.

I attempted similarities and divergences with my series, including 67 percent of primary augmentations (24 percent with pexy) and 33 percent of secondary augmentations. The access was inframammary in 32 cases. The pocket was partially subpectoral except for four submuscular and two subglandular pockets. I similarly used electrocautery and no drains. The postoperative protocol consisted of antibiotic/analgesic oral therapy, moderately compressive bandages for 5 to 6 days, local drainage only in secondary surgery with capsulectomy, compression bra for 1 to 2 months instead of 3 weeks, and physical activities reduced for 3 weeks but permitting moderate car driving. Two Baker grade II contractures were detected.

In the meantime, my experience has reached approximately 70 cases without further subglandular insertion or new malrotations. All 73 primary augmentations were performed in less than 2 years, were subglandular, and recorded 12 displacements (complication rate, 8.2 percent).1 On the basis of my study, the incidence of malrotation is, respectively, one and 60 (≤1.6 percent) in primary subpectoral augmentations with and without pexy, zero and one in primary subglandular augmentation, one and nine in secondary subpectoral substitution with and without pexy, and one and one in secondary subglandular substitution. The three malrotations occurred within the first 25 cases at the first 10 months of 510 prosthesis use in cosmetic surgery. In 2004, I was able to start and test the appliance for reconstruction, but results were less satisfactory than those achieved by the style 410 devices because of the highest extra projection and different slope, and the use was discontinued, but malrotation was never the reason. On the contrary, I believe the 510 prosthesis is valid for cosmetic surgery but requires refined skill and patient selection limited by the patient's expectations, breast and thorax anatomy, soft-tissue thickness, skin resilience, and other factors.

Pocket preparation must be very accurate to prevent rotation, as presumed by Schots et al., because the placement of the hyperprojected vertex cannot fail. The pocket must be a few millimeters wider than the device, at the lateral and lower limits above all. The envelope produced by dissection must be stretched after insertion to immobilize the prosthesis for the next weeks.

In the cited series,1 I suppose there were some limits, such as the number of surgeons, shorter learning curve, subglandular pocket, and likely poor patient selection. The discussion was interesting but the following items could likely be true: (1) the subglandular pocket is more exposed to excessive movements, (2) adherence among breast tissue and texture surface is protective, and (3) the double capsula can facilitate rotation but first produces shape distortion. I think that the cohesive frame of the dual gel can be really injured when some squeezing occurs during the insertion maneuver. The highly cohesive gel pole is not spherical inside and is scarcely deformable. In contrast, the surrounding less cohesive gel can warp during insertion. A patient complained of inconstant shape alterations of one prosthesis at the lateral right side lasting 6 months. The only clinical sign was moderate rippling at the same level.

Moreover, I observed a patient after a car crash with sternal bone fracture whose magnetic resonance imaging scan detected no inner displacement but only the detachment of a small portion of the most cohesive gel (Fig. 2). Thus, I can presume that malrotation could be related to incorrect manipulation and misplacement during surgery, perhaps even minimal, which becomes evident after conclusion of the healing process or worsening the initial deformation/displacement.

Fig. 2.

Fig. 2.

This implant requires much more planning and surgical refinements than usual, the shape is special, and the extra-projection highly cohesive vertex can produce a side effect of unnatural shape when its placement is not accurately preserved. Nevertheless, if the surgeon is able, the 510 prosthesis can guarantee long-lasting and consistent outcomes in both young and older patients. That is principally true for the partially submuscular, dual-plane, augmentation.

Egidio Riggio, M.D.

Unit of Plastic and Reconstructive Surgery

Fondazione Istituto Nazionale Tumori

Via Venezian, 1

20133 Milano, Italy

egidio.riggio@istitutotumori.mi.it

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DISCLOSURE

The author has no financial interest to declare in relation of the content of this communication.

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REFERENCES

1. Schots JM, Fechner MR, Hoogbergen MM, van Tits HW. Malrotation of the McGhan Style 510 prosthesis. Plast Reconstr Surg. 2010;126:261–265.
2. Riggio E. Extra projected breast implants in breast augmentation. Paper presented at: 2006 Aesthetic Surgery of the Breast: Safe Surgical Approach—Preop and Postop Breast Detection, 2nd European Symposium; Milan, Italy.
3. Riggio E. Extra projected anatomical implants. Paper presented at: 2007 XX Congress de la Société Française des Chirurgiens Esthétiques Plasticiens; Bordeaux, France.
4. Riggio E. Extra-projected dual cohesive silicone gel anatomical implants: Innovation for breast augmentation. In: Berhardt LV, ed. Advances in Medicine and Biology. Vol. 8. New York: Nova Science Publishers; 2010:273–295. Available at: https://www.novapublishers.com/catalog/product_info.php?products_id=14855; free download at: https://www.novapublishers.com/catalog/product_info.php?products_id=22172.

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