Bruce L. Cunningham

Safety and Effectiveness of Mentor’s MemoryGel Implants at 6 Years

BackgroundIn November 2006, the FDA approved the Premarket Approval PMA applications for the round, cohesive, silicone gel-filled breast implants of Mentor (MemoryGel) and Allergan. Since that time, the devices have been widely available to plastic surgeons and their use is rapidly eclipsing that of the saline breast implants. Patients in the Core clinical studies supporting these approvals continue to be followed through for 10 years, with comprehensive annual patient and physician-reported evaluations of safety and efficacy.MethodsOne thousand and eight (1,008) female patients had data collected on 1,898 implants, and were enrolled at 48 sites. Key complication rates were recorded with Kaplan–Meier estimated cumulative incidence calculation for each.ResultsRupture rate, suspected and confirmed, for primary augmentation was 1.1% (95% CI, 0.3–4.3), and that for primary reconstruction patients was 3.8% (95% CI, 1.4–9.8). Capsular contracture rates for clinically significant Baker III/IV contracture for primary augmentation was 9.8% (95% C I, 7.6–12.7), and that for primary reconstruction was 13.7% (95% CI, 9.7–19.1). The reoperation incidence for primary augmentation and primary reconstruction was 19.4 and 33.9%, respectively, with explantation and replacement with a study device in 3.9% of primary augmentations and 10.4% of primary reconstructions.ConclusionsMentor MemoryGel Silicone Breast implants represent a safe and effective choice for women seeking breast augmentation or breast reconstruction following mastectomy.

The effectiveness of surgical and nonsurgical interventions in relieving the symptoms of macromastia

&NA; In this report, the authors evaluate the effectiveness of breast reduction in alleviating the symptoms of macromastia by comparing baseline and postoperative health status using a series of well‐validated self‐report instruments. The study had a prospective design with a surgical intervention group and two control groups: a hypertrophy control group with bra cup sizes D or larger and a normal control group with bra cup sizes less than D. The effectiveness of nonsurgical interventions in relieving the symptoms of macromastia was also evaluated, both in the operative subjects and in the control groups. Surgical candidates and controls completed a self‐administered baseline survey that consisted of the following validated and standardized instruments commonly used to evaluate outcomes: SF‐36, EuroQol, Multidimensional Body‐Self Relations Questionnaire (MBSRQ), and the McGill Pain Questionnaire (MPQ). A specially designed and validated instrument, the Breast‐Related Symptoms (BRS), was also used. There were also questions about prior nonsurgical treatments, comorbid conditions, bra size, and a physical assessment. Additional information obtained on the operative subjects included surgical procedure data, resection weight, and complications. Approximately 6 to 9 months postoperatively, surgical subjects completed the same questionnaire as described above, and a final physical assessment was performed. The cohort included 179 operative subjects with matched preoperative and postoperative data sets, 96 normal controls and 88 hypertrophy controls. The women were predominantly Caucasian, middle‐aged, well educated, and employed. Fifty percent of the operative subjects reported breast‐related pain all or most of the time in the upper back, shoulders, neck, and lower back preoperatively compared with less than 10 percent postoperatively. Operative subjects and hypertrophy controls tried a number of conservative treatments, including weight loss, but none provided adequate permanent relief. Compared with population norms, the preoperative subjects had significantly lower scores (p < 0.05) in all eight health domains of the SF‐36, and in the mental and physical component summary scores. After surgery, the operative subjects had higher means (better health) than national norms in seven of the eight domains and improved significantly from presurgical means in all eight domains (p< 0.05). Before surgery, the operative subjects reported high levels of pain with a Pain Rating Index (PRI) score from the MPQ of 26.6. After surgery, pain was significantly lower with a mean PRI score of 11.7, similar to that of our controls (mean PRI score, 11.2). Regression analysis was used to control for covariate effects on the main study outcomes. Among the operative subjects, benefits from breast reduction were not associated with body weight, bra cup size, or weight of resection, with essentially all patients benefiting from surgery. Breast hypertrophy has a significant impact on womens health status and quality of life as measured by validated and widely used self‐report instruments including the SF‐36, MPQ, and EuroQol. Pain is a significant symptom in this disease, and both pain and overall health status are markedly improved by breast reduction. In this population, conservative measures such as weight loss, physical therapy, special brassieres, and medications did not provide effective permanent relief of symptoms. (Plast. Reconstr. Surg. 109: 1556, 2002.)

Analysis of breast reduction complications derived from the BRAVO study.

Background: Analysis of complication data derived from the Breast Reduction Assessment: Value and Outcomes (BRAVO) study, a 9-month prospective, multicenter trial, is presented. Methods: Data derived from 179 patients were analyzed, including bivariate associations between complications and single predictor variables (Fishers exact test or chi-square testing) or continuous variables (two-sample t test) and, finally, logistic regression. Results: The overall complication rate was 43 percent (77 patients). Simple, bivariate analysis linked preoperative breast volume, shoulder strap grooving, and a vertical incision with an increased incidence of complications (p < 0.05, 0.02, and 0.02, respectively). Delayed wound healing, the most common complication, correlated directly with average preoperative breast volume (p < 0.045), average resection weight/breast (p < 0.027), and smoking (p < 0.029) and inversely with age (p < 0.011). Vertical incision techniques were associated with an increased complication frequency (p < 0.05) without a link to specific complications. Logistic regression analysis associated resection weight as the sole variable for increased risk of complications (p = 0.05) and with absolute number of complications [mean resection weight of 791 g for patients without complications versus 847, 882, and 1752 g for patients with one, two, and three complications, respectively (p = 0.0022)]. Each 10-fold increase in resection weight increased the risk of complication 4.8 times and increased the risk of delayed healing 11.6 times. Conclusions: Complication data revealed several significant features: (1) resection weight correlated with increased risk and absolute number of complications; (2) delayed healing correlated directly with resection weight and inversely with increasing age, anesthesia times, and preoperative Short Form-36 bodily pain score; (3) a vertical incision may be associated with increased incidence of complications but requires further analysis; and most importantly, (4) the presence of complications had no negative effect on improvement in Short Form-36 and Multidimensional Body-Self Relations Questionnaire scores.

Saline-filled breast implants: A Plastic Surgery Educational Foundation multicenter outcomes study

In 1993, the Plastic Surgery Educational Foundation commissioned the senior author (Cunningham) to design an 11-center retrospective cohort outcomes study to obtain physician- and patient-reported data on saline-filled breast implants. Data were obtained from 504 patients with 995 saline-filled breast implants placed between January 1, 1980 and December 31, 1989, with a mean follow-up of 6 years. Most (93.8 percent) saline-filled breast implants were placed for breast augmentation. Of the 504 patients, 104 (20.6 percent) required reoperation for open capsulotomy or for replacement or removal of a deflated implant. Complications occurred in 22 patients (4.4 percent), with hematoma being most common. Implant deflation occurred in 55 implants (5.5 percent) and affected 51 patients (10.1 percent) but was underreported by chart abstraction alone. Risk factors for implant deflation included underfilling the implant by more than 25 cc (odds ratio 3.3, p = 0.0400), the use of model 1800 saline-filled breast implants (odds ratio 3.1, p = 0.0010), intraluminal antibiotics (odds ratio 2.6, p = 0.0183), and intraluminal steroids (odds ratio 2.4, p = 0.0711). Based on 44 of 55 saline-filled breast implants with known deflation dates, actuarial survival is 95.7 to 98.0 percent at 5 years and 90.2 to 95.2 percent at 10 years (95 percent confidence interval). Significant periprosthetic capsular contracture affected 103 patients (20.4 percent) during follow-up. Risk factors for capsular contracture included omitting intraluminal antibiotics (odds ratio 16.7, p = 0.0001), omitting intraluminal steroids (odds ratio 12.5, p = 0.0001), submammary placement of the saline-filled breast implant (odds ratio 7.8, p = 0.0001), and use of antibiotics in the implant pocket (odds ratio 6.1, p = 0.0001). Overall patient satisfaction with saline-filled breast implants was rated as high by 94.2 percent, and 94.8 percent of patients would choose saline-filled breast implants again. Dissatisfaction with their saline-filled breast implants was more frequent in patients with significant breast firmness (odds ratio 22.9, p = 0.0001), those undergoing prophylactic mastectomy (odds ratio 8.2, p = 0.0005), and those desiring smaller implants (odds ratio 6.9, p = 0.0001). In conclusion, saline-filled breast implants are a safe alternative to silicone gel-filled breast implants and demonstrate a high rate of patient satisfaction. Underfilling of saline-filled breast implants should be avoided because it contributes to deflation. Although intraluminal antibiotics and steroids protect against capsular contracture, they also contribute to saline-filled breast implant deflation. The incidence of capsular contracture is decreased by placing the saline-filled breast implant in the subpectoral position. Finally, patients should be aware of the possible need for reoperations related to their implants.

The Mentor Core Study on Silicone MemoryGel Breast Implants.

Background: In 2005, convincing safety and efficacy data were presented, resulting in the approval of Mentor MemoryGel Implants, with conditions. Methods: The 1007 women enrolled in the 10-year, multicenter, Mentor Core MemoryGel Study were distributed into four cohorts: 551 primary augmentation patients, 146 revision-augmentation patients, 251 primary reconstruction patients, and 59 revision-reconstruction patients. Preoperatively and postoperatively, study instruments and physical examinations were administered to assess medical history, patient satisfaction, quality of life and body image, connective tissue disease diagnosis, rheumatology symptoms, and chest size change to determine the efficacy of surgery. Results: Safety assessments included complication rates and rates of reoperation. Results at 3 years were reported at the U.S. Food and Drug Administration panel. Results indicate that the risk of any complication (including reoperation) at some point through 3 years after implant surgery is 36.6 percent for primary patients, 50.1 percent for revision-augmentation patients, 49.4 percent for primary reconstruction patients, and 47.5 percent for revision-reconstruction patients. Suspected rupture rates reported from the magnetic resonance imaging cohort were 0.5 percent for primary augmentation, 7.7 percent for revision-augmentation, 0.9 percent for primary reconstruction, and 0 percent for revision-reconstruction. Only two implants, in a single patient, were found surgically to be ruptured. There were 4.7 percent primary and 12.3 percent revision-augmentation patients who had their implants removed, with patient choice and severe capsular contracture being the most common reasons. Conclusion: The data demonstrated safety and efficacy of the devices, but also indicate that a focus must be placed on better education and technique to improve clinical outcomes in the future.

Saline-filled breast implant safety and efficacy: a multicenter retrospective review.

Our center undertook an industry-funded, outcomes-based, multicenter, retrospective review to evaluate the safety and efficacy of saline-filled breast implants. Our review was part of a pre–market approval review process mandated by the U.S. Food and Drug Administration. The design of our review was modeled on a Plastic Surgery Educational Foundation outcomes study previously conducted by our center. For this study, several significant changes were made to our previous protocol, including improved patient tracking, stronger biostatistical support, and a mandatory 10-year minimum patient follow-up period. Physician-reported and patient-reported data on 450 patients with 882 saline-filled breast implants placed between January 1, 1980, and June 30, 1986, were obtained. Mean patient follow-up period was 13.0 years. Most implants (93.9 percent) were placed for breast augmentation. Seventy-four percent were placed in a submammary position; 25.6 percent, subpectorally; and 0.2 percent, subcutaneously. The overall complication rate was 20.2 percent. Reoperation for capsular contracture or implant deflation was necessary in 104 of 450 patients (23.1 percent). Deflation occurred in 73 implants (8.3 percent) and was underreported according to the physicians’ record review alone. This deflation rate is higher than the 5.5 percent previously reported by our center. However, 26 of these 73 deflations (35.6 percent) occurred in a single cohort of patients at one center using Surgitek saline implants. If this cohort is excluded, the deflation rate drops to 5.8 percent, a figure more consistent with data published in the literature and found in our previous study. Of the 73 deflations, spontaneous deflation was reported for 50 (74.6 percent), and the remainder were iatrogenic. Actuarial survival of the non-Surgitek implants was 98.4 percent to 99.8 percent at 5 years and 96.9 percent to 98.9 percent at 10 years (95 percent confidence interval). Risk factors for implant deflation included the use of Surgitek saline-filled implants (odds ratio = 17.5, p < 0.01), use of Heyer-Schulte and Mentor model 1800 implants (odds ratio = 3.0, p < 0.01), and implant size greater than 450 cc (odds ratio = 1.01, p < 0.02). Risk factors for capsular contracture included submammary implant position (odds ratio = 2.05, p = 0.03) and implant size greater than 450 cc (odds ratio = 1.01, p < 0.01). Overall, satisfaction was high: 93 percent of patients were “satisfied” or “very satisfied” with their implants. As in our earlier study, risk factors for patient dissatisfaction were reconstruction after mastectomy (odds ratio = 7.6, p = 0.011), significant breast firmness (odds ratio = 6.2, p < 0.001), and patient desire for smaller implants (odds ratio = 3.0, p = 0.020). In conclusion, our review provides additional outcomes-based evidence that saline-filled breast implants remain a safe, effective alternative to silicone gel–filled models. (Plast. Reconstr. Surg. 105: 2143, 2000.)

The Mentor Study on Contour Profile Gel Silicone MemoryGel Breast Implants.

Background: Two-year safety and efficacy data were presented to the Canadian Therapeutic Products Directorate Scientific Advisory Panel, in Ottawa, Ontario, Canada. Methods: The 955 women enrolled in the 10-year, multicenter, Mentor MemoryGel study were distributed into four cohorts: 572 augmentation patients, 123 revision-augmentation patients, 191 reconstruction patients, and 69 revision-reconstruction patients. The surgeons in the study received an intensive clinical educational program in addition to the protocol. Results: Mentor’s 2-year study results indicate that the risk of any complication or reoperation at some point through 2 years after implant surgery is 24.5 percent for primary augmentation patients, 30.2 percent for revision-augmentation patients, 42.9 percent for primary reconstruction patients, and 41.8 percent for revision-reconstruction patients. The rupture rates reported from the magnetic resonance imaging cohort were 0 percent for all groups. Patients reoperated on at least one time were as follows: 9.4 percent for primary augmentation, 12.8 percent for revision-augmentation, 27.3 percent for primary reconstruction, and 19.4 percent for revision-reconstruction. Also, 2.4 percent of primary augmentation patients, 7.3 percent of revision-augmentation patients, 8.9 percent of primary, and 11.6 percent of reconstruction patients had their implants removed, with patient choice and capsular contracture being the most common reasons. Conclusions: The data from the Mentor CPG Gel Study resulted in approval of these implants for general use on October 20, 2006. The educational program resulted in improved clinical outcomes and probably should be required for all surgeons using the devices.

Reduction Mammaplasty: Defining Medical Necessity:

The authors evaluated existing and new criteria for defining the medical necessity for breast reduction surgery. Two cohorts of women (those requesting breast reduction surgery [N = 266] and a group of controls [N = 184]) completed a questionnaire including breast-specific symptom severity, the Short Form 36, the EuroQol, the McGill Pain Questionnaire, and the Multidimensional Body Self Relations Questionnaire. To evaluate prediction validity, the most widely accepted decision criteria and a new definition of medical necessity were applied to the data set to determine whether women meeting the definition had more favorable outcomes than those who did not as measured by validated self-report instruments. For existing criteria, women not meeting and meeting the criterion gained equal benefit from surgery. Women meeting the new definition (2 of 7 physical symptoms all or most of the time) had significantly greater improvement scores on 4 of the 5 health burden measures compared to women not meeting this definition. The authors conclude that medical necessity for breast reduction surgery is better defined by self-report of symptoms than by existing criteria.

Fournier's syndrome following anorectal examination and mucosal biopsy.

SummaryWe have presented a rare instance of Fourniers synergistic gangrene following anorectal examination and biopsy. Early diagnosis and extensive debridement were necessary. Extensive debridement necessitated a significant reconstruction task. This technique of genital reconstruction should be familiar to surgeons dealing with colonic and rectal disease.

Free flap transfers in rats using an irradiated recipient site

Abstract As clinical experience with free flaps increases, new applications have been discovered. Recently Panje and Krause (1977) have used them to reconstruct extensive oropharyn-geal defects at the time of tumour resection. In their report of 8 flaps, 2 failures were in recipients of preoperative irradiation. If free flaps are to be employed in the reconstruction of patients with head and neck malignancies, the effect of radiation to the recipient bed and vessels must be known. Tanet al. (1978) found only a 50 per cent success rate in free flap transfers in rabbits using 2,000 rad irradiated recipient vessels. However, Baker and Krause (1978) have recently demonstrated good patency in arterial anastomoses performed on rat arteries following therapeutic dose irradiation. The present study was designed to demonstrate the effect of therapeutic dose irradiation on the recipient bed vasculature and in particular its influence on the viability of free flap isografts in laboratory rats.