No differences in aesthetic outcome or patient satisfaction between anatomically shaped and round expandable implants in bilateral breast reconstructions: a randomized study.

BACKGROUND: The demand for bilateral mastectomy and immediate breast reconstruction has increased in recent years, primarily due to the development of genetic testing. The aim of this study was to evaluate if there was a difference between anatomically shaped and round permanent expandable implants in one-stage bilateral breast reconstruction after bilateral prophylactic mastectomy. METHODS: The anatomically shaped permanent expander implant McGhan Style 150 (Inamed, Santa Barbara, Calif.) was compared with the round permanent expander implant Siltex Becker 25 (Mentor, Santa Barbara, Calif.). Thirty-six women who opted for bilateral prophylactic mastectomy and immediate reconstruction with implants from 2004 to 2006 were included and randomly assigned to each group [18 women (36 breasts) per group]. Time to follow-up was a minimum of 2 years after the bilateral prophylactic mastectomy. Implant-related complications, breast symmetry, aesthetic outcome, and patient satisfaction were evaluated. Aesthetic outcome was evaluated by an expert panel that also tried to recognize if the breasts were reconstructed with anatomically shaped or round implants. Patient satisfaction was evaluated by a questionnaire. RESULTS: Average time to follow-up was 30 months (range, 24 to 49 months). There was no statistical difference between the two implant groups in terms of complications, breast symmetry, or outcome scores from the expert panel and patient assessment. The expert panel guessed the right implant shape in 42 percent of the anatomically shaped implants and 66 percent of the round implants. CONCLUSION: In immediate one-stage breast reconstruction after bilateral prophylactic skin-sparing mastectomy, anatomically shaped and round permanent expander implants had comparable complication rates, aesthetic outcomes, and patient satisfaction after 2 years of follow-up.

Patient satisfaction with aesthetic outcome after bilateral prophylactic mastectomy and immediate reconstruction with implants.

UNLABELLED: Previous studies regarding body image after bilateral prophylactic mastectomy with breast reconstruction have reported a risk of reduced satisfaction with body image and adverse effects on sexual life. The aim of this retrospective study was to find areas for future surgical improvements to optimize patient satisfaction with the aesthetic result after bilateral prophylactic mastectomy and immediate breast reconstruction with implants. Nipple-areola complexes were reconstructed. Twenty-four consecutive and standardized operated women were included. The follow-up time was an average of 5.4 (range: 2.4-10.2) years. The outcome in terms of breast symmetry, size, and firmness were measured with objective and subjective methods, and results were compared to those from a control group of 24 women. Patient satisfaction was evaluated with a questionnaire. Main findings were that the overall aesthetic result was regarded as good in both objective and subjective evaluations and that breast symmetry in patients was as common as in the control group, but reconstructed breasts were firmer. Twenty of 24 patients thought that the aesthetic result exceeded their expectations, and 22/24 would recommend this kind of breast reconstruction to another woman. In contrast with the predictions of plastic surgeons, patients were most dissatisfied with the nipple-areola reconstruction. CONCLUSIONS: The overall aesthetic result after bilateral prophylactic mastectomy and immediate breast reconstruction with implants was good and symmetrical. Patient satisfaction with nipple-areola reconstruction was only moderate. The results emphasize the importance of a preoperative discussion with the patient regarding whether to keep or reconstruct the nipple-areola complex while planning a prophylactic mastectomy.

Placebo-controlled trial of local anaesthesia for treatment of pain after breast reconstruction.

Breast reconstruction with submuscular tissue implants is associated with substantial postoperative pain. High pain scores despite large doses of opioids were described in earlier studies, which indicated that opioids alone or together with paracetamol are insufficient. In the present placebo-controlled study we aimed to evaluate the analgesic efficacy of local anaesthesia as a supplement. Forty-three women who had previously been operated on for breast cancer and were listed for unilateral secondary breast reconstruction were assigned at random to one of two groups. The patients received 2.5 mg/ml levobupivacaine (Chirocaine) 15 ml or placebo in a double-blind manner through an indwelling catheter in the operation site every three hours for 45 hours. All patients were given oral paracetamol 1 g x 4 orally and morphine intravenously as patient-controlled analgesia. A visual analogue scale (VAS) was used to assess the intensity of the postoperative pain. Amount of morphine used was recorded. The women in the levobupivacaine group (n=21) reported significantly less pain at rest during the first 15 hours postoperatively (p<0.05). During mobilisation the intensity of pain was lower for the first six hours (p=0.01) and for the interval 18-24 hours (p=0.045) in the same group. Total mean (SD) consumption of opioids in the levobupivacaine and placebo groups was 24.6 mg (22.88) and 33.8 mg (30.82), respectively (p=0.28). After reconstruction, levobupivacaine injected locally every third hour as a supplement to paracetamol orally and morphine given by PCA resulted in improved pain relief at rest and during mobilisation. Morphine consumption was reduced, but this was not significant (p=0.28).

Psychological reactions, quality of life, and body image after bilateral prophylactic mastectomy in women at high risk for breast cancer: a prospective 1-year follow-up study.

PURPOSE: To prospectively evaluate body image, sexuality, emotional reactions (anxiety, depression), and quality of life in a sample of women having increased risk for breast cancer before and 6 months and 1 year after bilateral prophylactic mastectomy (BPM), and to compare preoperative expectations of the operation with postoperative reactions concerning the impact on six areas of the women's lives. PATIENTS AND METHODS: A total of 90 of 98 consecutive women who underwent BPM during October 1997 to December 2005 were included. Data were collected by self-administered questionnaires (eg, Hospital Anxiety and Depression scale, Swedish Short Term-36 Health Survey, Body Image Scale, Sexual Activity Questionnaire) before the operation (n = 81), and 6 (n = 71) and 12 months (n = 65) after BPM. RESULTS: Anxiety decreased over time (P = .0004). No corresponding difference was found for depression. No differences in health-related quality of life over time were found, with one exception. A substantial proportion of the women reported problems with body image 1 year after BPM (eg, self consciousness, 48%; feeling less sexually attractive, 48%; and dissatisfaction with the scars, 44%). Sexual pleasure was rated lower 1-year post-BPM as compared with before operation (P = .005), but no differences over time in habit, discomfort, or activity were found. CONCLUSION: No negative effects on anxiety, depression, and quality of life were found. Anxiety and social activities improved. Negative impact on sexuality and body image was reported.

Sensitivity after bilateral prophylactic mastectomy and immediate reconstruction.

The purpose of this retrospective study was to evaluate the cutaneous somatosensory function and patients' subjective experience after bilateral prophylactic mastectomy and immediate reconstruction with implants. Twenty-four patients treated during an eight-year period were included. Somatosensory examination was made at least two years after the latest surgery to study perception thresholds to touch, warmth, cold, and heat pain, using quantitative techniques. Patients also completed a questionnaire about subjective sensitivity. Sixteen women who had had no previous breast surgery were used as a control group. Most patients reported decreased sensitivity in the breasts, which was confirmed by the results from the quantitative somatosensory examination. The results also showed that the ability to experience sexual feelings in the breast is usually lost after this type of operation, and as many as 14 patients reported spontaneous or stimulus-evoked discomfort in the breasts.

Prospective study comparing two brands of cohesive gel breast implants with anatomic shape: 5-year follow-up evaluation.

BACKGROUND: The new generation of breast implants has an anatomic shape. These implants are made with a textured shell and filled with a cohesive silicone gel. Available since 1993 except in the United States, these implants are gaining in popularity for breast enlargement and reconstruction. This prospective, randomized, controlled, and blinded study was designed to compare mid- and long-term results with the use of cohesive gel-filled implants from two different manufacturers: Style 410 of the McGhan brand (MG) made by Allergan and Vertex made by Eurosilicone (ES). METHODS: From May 1997 to May 1999, 80 women underwent breast augmentation: 40 with Style 410 implants (MG) and 40 with Vertex implants (ES). All surgeries were performed by the same surgeon (I.N.). Another physician (G.J.) interviewed and examined 64 of these women (80%) 4 to 6 years (median, 5 years) after implantation. In addition, 10 patients responded to the same questionnaire and were interviewed by phone, bringing the follow-up rate to 92.5%. RESULTS: Overall, satisfaction was high, with 98.6% of the patients evaluated after 4 to 6 years "very satisfied" or "satisfied" with the result in general. Approximately 20% of the patients who responded judged their breasts to be firmer than desirable. Breast augmentation classification (BAC) was used to grade the breast firmness of the 64 patients examined by G. J. At examination, 24% of patients had soft breasts, 53% had slightly firm breasts, and 23% had moderately firm breasts. That last category also was classified as capsular contracture. No patient was graded as having very hard breasts (BAC 4). Skin sensitivity of the breast adjacent to the incision was altered for 25% of the patients. The implant rotated in four patients (5%). Breast firmness, implant palpability, nipple sensitivity, and skin sensitivity were further analyzed by implant location (submuscular vs subglandular) and implant size (volume). Frequency of the breast asymmetries and the impact of augmentation on asymmetric breasts also was studied. All these analyses were performed with the entire pool of examined patients who answered the follow-up questionnaire. Data also were analyzed by distinguishing between results of the two each implant manufacturers. The results showed no difference between the Eurosilicone and McGhan implants except for the self-evaluation of "breast consistency" by the patient. A higher percentage of patients with the Vertex implants than with the McGhan implants reported that their breast was "firmer than desired." CONCLUSIONS: Breast augmentation with anatomic, textured, cohesive silicone gel-filled implants is a reliable procedure with consistently good results. The results also show that candidates for breast enlargement should be informed that their implanted breast may feel firmer than their natural breasts. They also may experience reduced sensation of their nipple or breast skin.

Technical aspects of immediate breast reconstruction with implants: five year follow-up.

We describe the technical aspects of 249 patients who had immediate breast reconstruction with implants and a follow-up of at least five years. The type of reconstruction was permanent expander prostheses (n=208), permanent prostheses (n=32), and temporary expander prostheses (n=9). The median total number of operations required to complete the reconstruction was 3 (range 1-6) with nipple-reconstruction included. Thirty-two patients developed local complications (13%) and three had systemic complications (1%). Eighteen implants were lost, so the failure rate of reconstruction was 7%. The technique of immediate breast reconstruction with implants is associated with a low overall morbidity. This, combined with earlier reported psychological advantages, no increased risk of cancer relapse, and reasonable cost, indicates the importance of immediate reconstruction with implants in the treatment of breast cancer.

Quality of life and patient satisfaction in breast cancer patients after immediate breast reconstruction: a prospective study.

The aim of immediate breast reconstruction is to improve well-being and quality of life for women undergoing mastectomy for breast cancer. This prospective study used the SF-36 Health Survey questionnaire to assess quality of life before and 12 months after mastectomy and immediate breast reconstruction together with patients' expectations of and satisfaction with the immediate breast reconstruction with implant. Scores for 76 participants were compared with those in 920 age-matched women from the general population. Preoperative scores for emotional well-being and physical role functioning were lower than in the reference population, while after 12 months the scores in all domains had improved and were comparable with those in the reference population. The most common reason for immediate reconstruction was the desire to avoid an external prosthesis. Most women were satisfied with immediate reconstruction, and the major determinant of aesthetic satisfaction was completion of the procedure. Although many factors may influence quality of life, 1 year after breast cancer surgery with immediate reconstruction scores are equivalent to those of the normal population.

Objective evaluation of two differently-shaped permanent expander prostheses used for breast reconstruction.

When a breast is being reconstructed with an implant, a capsule of connective tissue always forms around the implant and a capsular contracture can develop. Radiotherapy increases the incidence of capsular contracture. To evaluate the results after breast reconstruction with differently-shaped textured implants, and the effect of radiotherapy on the softness of the reconstruction, 140 patients given permanent breast expander prostheses between 1994 and 2000 were studied. In 99 patients a round implant and in 41 an anatomically-shaped implant was used. Radiotherapy was given to 24 patients. For objective assessment, applanation tonometry was recorded when the desired breast volume was achieved, and 6 and 12 months later. This study showed that, regardless of the shape of the implant, the softness of the breast reconstruction was similar, as shown by the contact area of the applanation tonometry disc. Radiotherapy transiently reduced the softness of the breast.