Per Hedén

Style 410 cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation.

Background: Inamed introduced a fourth-generation implant, the Style 410 cohesive silicone breast implant, in 1993. To date, little has been published on this implant despite its widespread use in Europe, and no data are available on its long-term rupture rate. Methods: Women implanted with Style 410 implants between 1995 and 1999 at Akademikliniken Hospital in Stockholm were eligible to participate in the study. One hundred forty-four of 302 potential subjects received a physical examination, underwent magnetic resonance imaging screening for silent rupture, and completed a quality-of-life survey. The majority of subjects were Caucasian (96 percent), with a median age of 39 years. The study population consisted of subjects with cosmetic augmentation (86 percent) or revision of previous breast implantation (14 percent). Median time elapsed between physical examination and magnetic resonance imaging was 2 days. Results: The 144 subjects provided 286 implants for magnetic resonance imaging assessment, with a median implantation time of 6 years (range, 5 to 9 years). Overall, 99.0 percent of implants showed no evidence of rupture, 0.3 percent showed evidence of rupture, and 0.7 percent were indeterminate. The most common complication noted at physical examination was capsular contracture (5.6 percent). All other complications occurred in less than 3 percent of subjects. Quality-of-life results found an improvement in overall sense of well-being for 87 percent of subjects. Most compelling is that 97 percent stated an overall feeling that their breast implantation had been advantageous. Conclusions: The authors’ findings support the long-term safety and effectiveness of Inamed Style 410 cohesive breast implants and demonstrate a low prevalence of rupture.

Global flap ischemia: a comparison of arterial versus venous etiology.

It has been suggested by clinical observations that acute venous thrombosis following free-flap surgery results in more severe tissue injury than postoperative arterial thrombosis. This current study, in the pig model, was designed (1) to determine the rate of survival and the percentage area of flap survival in both cutaneous and myocutaneous flaps following a secondary venous ischemic insult, (2) to compare this with findings following a secondary arterial ischemic insult, and (3) to determine the reliability of laser Doppler flowmetry and dermoflu-orometry index in the prediction of necrosis outcome following both venous and arterial ischemic insults.A total of 116 flaps were elevated in 29 pigs. Data analysis documented a decrease in the rate of flaps surviving venous ischemia as compared with arterial ischemia or control and of arterial ischemia as compared with control. In contrast to our previous work, a lower rate of buttock flaps survived a secondary ischemic insult (of either arterial or venous etiology) than did the cutaneous component of the myocutaneous flaps. As expected, as the length of ischemia increased, the rate of flaps surviving decreased, as did the percentage area of survival. Although laser Doppler performed slightly better than dermofluo-rometry index, as measured on immediate reperfusion following secondary venous ischemia, both were relatively poor predictors of eventual survival or necrosis. Under conditions of immediate reperfusion following secondary arterial ischemia, dermofluorometry index proved to be a superior predictor of ultimate necrosis as compared with laser Doppler flowmetry. (Plast. Reconstr. Surg. 93: 1485, 1994.)

Body Shaping and Volume Restoration: The Role of Hyaluronic Acid

Driven by the rising popularity of minimally invasive techniques, the demand for cosmetic procedures is increasing. Cosmetic body-shaping procedures can be categorized into those that remove tissue and those that add volume. This review focuses on the latter of these categories, particularly on the use of resorbable hyaluronic acid gels specifically developed for minimally invasive volume enhancement. Pilot studies of hyaluronic acid involving its injection to contour various body deformities and its recent use in female breast augmentation are discussed. Injectable hyaluronic acid is effective and well tolerated. It represents an attractive treatment option for volume restoration or augmentation by providing predictable long-lasting results after minimally invasive administration. Alternative treatment options for volume enhancement also are summarized including fat transfer, silicone implants, and the use of injectable nonresorbable products such as silicone, polyalkylimide, and polyacrylamide gels. As patients continue to opt for nonsurgical procedures that offer predictable results, the development of minimally invasive products such as hyaluronic acid is increasingly important.

Macrolane for breast enhancement: 12-month follow-up.

Background: Stabilized hyaluronic acid–based gel of nonanimal origin (NASHA-based gel) is well established for use in aesthetic facial procedures. A new formulation (Macrolane VRF30, Q-Med AB, Uppsala, Sweden) may be suitable for patients seeking breast enhancement. The aim of this study was to develop a reproducible technique for injecting NASHA-based gel posterior to the mammary gland (subglandular injection) and to assess treatment safety and efficacy. The feasibility of dual-plane submuscular injection was also explored. Methods: Nonpregnant, nonbreastfeeding women with small breasts were recruited for this open-label, noncomparative study. Patients were treated in groups of four to enable step-wise revision of the injection technique. Safety and efficacy assessments (12-month follow-up) included adverse event reporting and the Global Aesthetic Improvement Scale, respectively. Results: Twenty-four women (mean age, 37 years) were recruited, 20 of whom underwent subglandular injection. A reproducible injection technique was successfully developed that could be performed under local anesthesia. High subject improvement rates for breast appearance (38 of 46 breasts; 83 percent) were observed for at least 6 months after treatment. At 12 months, 69 percent of breasts were still considered improved. Similar trends were observed with patient satisfaction levels. NASHA-based gel was generally well tolerated, with no inflammatory reactions or serious adverse events. Capsular contracture was the most commonly reported adverse event. Conclusion: NASHA-based gel is a new option for patients who desire aesthetic improvement of the breast but who do not want to undergo surgery. Further studies to confirm these findings in larger numbers of patients are warranted.

Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness

Implant texture is an important factor influencing implant selection for breast augmentation. Natrelle Biocell implants are characterized by macrotextured shell surfaces containing irregularly arranged concavities with large open-pore diameters and depths. These properties facilitate adhesion of the implant to the surrounding tissue, thereby promoting implant immobilization. Relative to implants with other surfaces, macrotextured implants offer low rates of capsular contracture; low rates of malposition, rotation, and rippling; and high rates of patient satisfaction. However, macrotextured implants are associated with a slightly higher risk of double capsule and late seroma. The surgeon can minimize these risks with straightforward techniques that encourage tissue adhesion. This report presents experience-based recommendations to optimize the effectiveness of Biocell anatomic implants. The authors discuss the application of best practices to all aspects of the breast implantation process, from implant selection and surgical planning to operative technique and postoperative management. LEVEL OF EVIDENCE 3.

Three-dimensional simulated images in breast augmentation surgery: an investigation of patients' satisfaction and the correlation between prediction and actual outcome.

Background: Breast augmentation is one of the most commonly performed operations. Three-dimensional outcome simulation can be used to predict and demonstrate for the patient what the planned operation aims to achieve in terms of size and shape. However, there are still few studies in the literature that look at how close the simulation is to the actual postoperative result and how patients perceive the accuracy and usefulness of the simulation. Methods: A prospective series of 150 patients underwent breast augmentation following consultation with the aid of three-dimensional simulation images. These patients were evaluated with a questionnaire 6 months postoperatively. A retrospective chart review of 52 patients whose three-dimensional simulations were compared with the postoperative photographs were evaluated and graded by an independent panel of investigators. Results: The independent panel graded the overall similarity of the three-dimensional simulations to the actual breasts with a total average score ± SD of 7.5 ± 0.80 (range, 4.5 to 8.9) using a visual analogue scale ranging from 1 to 10. The highest average score was given to projection, breast width, and height (7.8); the lowest average score was given to intermammary distance (7.0). Eighty-six percent of patients felt the simulated image was very accurate in predicting the actual result of their breasts. Conclusions: Patients prefer a center that offers three-dimensional imaging technology; they feel that the simulation is very accurate and helps them very much in choosing the implant; if they could go back in time, they would choose the same implant again. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

A Four-Layer Wound Closure Technique with Barbed Sutures for Stable Reset of the Inframammary Fold in Breast Augmentation

The inframammary fold (IMF) is an important anatomical landmark with regards to aesthetic appearance of the breast. After implantation a new IMF often needs to be recreated, sutured, and secured to its new position to avoid displacement during the healing process. In order to obtain optimal results it is crucial to achieve a well-defined and accurately positioned IMF with the scar lying exactly in it. To prevent scar dislocation it is also important to provide sufficient length of skin between the nipple and the fold. This length should be adjusted according to the amount of covering gland and to the implants height and projection. In this series, all implants were placed with a dual-plane technique but the importance of securing and stabilizing the submammary fold after implantation applies to all planes of implant placement in breast augmentation via a submammary incision. The authors present a simple method that provides accurate, stable, and long lasting repositioning of the new IMF with a four-layer wound closure technique using barbed sutures. These sutures have recently become more popular across a number of surgical specialties as well as in plastic surgery, since their introduction in 1967 for tendon repair.

Mastopexy Augmentation with Form Stable Breast Implants

Mastopexy combined with augmentations is considered to be a technically advanced and difficult procedure; thus, many surgeons recommend doing this procedure in two separate stages to minimize the risk for complications. A one-stage procedure has, however, several advantages. Even if one-stage mastopexy augmentations are more technically demanding to perform and even if a slightly increased risk for healing problems exists, these procedures can be performed safely if the planning and surgical technique are accurate. The planning and surgical technique described in this article have been used by the author for the past 10 years, with moderate modification in the twenty-first century, leading to a predictable outcome with a low degree of reoperations and complications. This article describes in detail the surgical technique and planning.

Reconstruction in the head and neck regions with free radial forearm flaps and split-rib bone grafts☆

Fifty patients with wound defects in the head and neck region underwent reconstruction with the free radial forearm flap. Mandible defects in 17 patients were reconstructed by split-rib bone grafts. Radiotherapy was administered to 44 patients preoperatively. The free flap was successful in 49 patients, and there was one case of partial flap necrosis. The free flap is soft, thin, and movable. The split-rib bone graft was successful in 15 patients, and there was one case of partial graft necrosis and one case of complete necrosis. Postoperative complications were decreased by 50 percent when compared with the complication rate when split ribs were covered by forehead flaps, deltopectoral flaps, or oral mucosa. Finally, the functional and cosmetic results were excellent.

Results after resection of intraoral cancer and reconstruction with the free radial forearm flap

Between 1989 and 1996, 47 patients with an intraoral squamous cell carcinoma underwent tumor resection and reconstruction with a free volar forearm flap. Tumor resection and neck dissection were performed by a head and neck surgeon and the free tissue transfer by a plastic surgeon. Preoperative radiation therapy was given to 44 of 47 patients and postoperative radiation therapy to 2. One other patient was not irradiated. There were 15 females and 32 males, with a mean age of 61 years. The primary site of the cancer was the tongue in 15 cases, the floor of the mouth in 15, the tonsil in 10, the bucca in 3 and the retromolar trigone in 4 cases. The flap was harvested from the left forearm in 34 and from the right in 13 patients. The mean operation time was 10 h (range 6–20) and the mean intraoperative bleeding was 486 ml (250–2,500). Forty-four of 46 flaps healed completely. Twelve revisions on 9 free flaps were performed between 6 h and 6 days postoperatively. Overall revisional surgery was done in 9 of 47 cases (19%). Two flaps could not be saved (4%). Infections/fistulas in the neck occurred in 11 of 46 cases (24%). Complete healing of the donor site occurred at a mean of 2.5 months (1–5). Nine patients developed complications at the donor site, 3 hematomas and 6 superficial infections (19%). Twenty-seven of 47 patients are still alive (57%). The mean survival time was 49 months (16–71).