Prospective evaluation of late cosmetic results following breast reconstruction: I. Implant reconstruction

The long-term cosmetic outcome of breast implant reconstruction is unknown. The morbidity and cosmetic outcome of 360 patients who underwent immediate postmastectomy breast reconstruction with various types of implants have been analyzed prospectively over a 9-year period. Of these patients, 334 who completed their reconstruction were suitable for evaluation of their cosmetic outcome. The early complication rate (< 2 months) was 9.2 percent, with an explantation rate of 1.7 percent. The late complication rate (> 2 months) was 23 percent, with a pathological capsular contracture rate of 11 percent at 2 years and 15 percent at 5 years and an implant removal rate of 7 percent. The revisional surgery rate was 30.2 percent.The cosmetic results were assessed prospectively using an objective five-point global scale. Every patient was scored at each visit once surgery was completed. The overall cosmetic outcome deteriorated in a linear fashion, from an initial acceptable result of 86 percent 2 years after patients completed their reconstruction to only 54 percent at 5 years. This decline in cosmetic outcome was not associated with the type of implant used, the volume of the implant, the age of the patient, or the type of mastectomy incision employed. Radiotherapy was not a significant factor because only 28 patients were irradiated. Upon Cox model analysis, pathological capsular contracture was the only factor that contributed significantly to a poor cosmetic outcome in which p < 0.0001 (relative risk 6.3). Despite a high revisional surgery rate, deterioration still occurred, suggesting that other unaccounted for variables were responsible. On photographic retrospective review of the patients without capsular contracture who demonstrated deterioration in their cosmetic scores, it became clear that a possible reason for their poor results was late asymmetry produced by the failure of both breasts to undergo symmetrical ptosis with aging.     

The correction of capsular contracture by conversion to "dual-plane" positioning: technique and outcomes

Little has been published regarding the treatment of patients with long-established capsular contracture after previous submuscular or subglandular breast augmentation. This study reviews 7 years of experience in treating established capsular contracture after augmentation mammaplasty by relocating implants to the "dual-plane" or partly subpectoral position. A retrospective chart review was performed on all patients who were treated for capsular contracture using this technique between 1993 and 1999. Data collected included the date of the original augmentation, the original implant location, date of revision and type of implant used, length of follow-up, outcome, and any ensuing complications. Different surgical techniques were used, depending on whether the prior implant was located in a subglandular or submuscular plane. All patients had revisions such that their implants were relocated to a dual plane, with the superior two thirds or so of the implant located beneath the pectoralis major muscle and the inferior one third located subglandularly. Of 85 patients reviewed, 54 had their original implants in a submuscular position and 31 had their initial augmentation in a subglandular position. Of the 54 patients whose implants were initially submuscular, 23 patients (43 percent) had silicone gel implants, 15 patients (28 percent) had double-lumen implants, and the remaining 16 patients (30 percent) had saline implants. Of the 31 patients whose implants were initially subglandular, 20 patients (65 percent) had silicone gel implants, three patients (10 percent) had double-lumen implants, and the remaining eight patients (26 percent) had saline implants. Fifty-one patients (60 percent) had replacement with saline implants (37 smooth saline, 14 textured saline), whereas 34 (40 percent) had silicone gel implants (seven smooth gel, 27 textured gel). The average time from previous augmentation to revision was 9 years 9 months. The average follow-up time after conversion to the dual-plane position was 11.5 months. Only three of 85 patients required reoperation for complications, all of which involved some degree of implant malposition. Of patients converted to the dual plane, 98 percent were free of capsular contracture and were Baker class I at follow-up, whereas 2 percent were judged as Baker class II. There were no Baker level III or IV contractures at follow-up. The dual-plane method of breast augmentation has proved to be an effective technique for correcting established capsular contracture after previous augmentation mammaplasty. This technique appears to be effective when performed with either silicone or saline-filled implants.     

The use of Teflon in orbital floor reconstruction following blunt facial trauma: a 20-year experience

A myriad of materials have been used for reestablishing continuity of the orbital floor following blunt facial trauma. Traditionally, autogenous grafts have been the material of choice for orbital floor reconstruction; however, alloplastic materials have gained popularity because of their availability and ease of use. A large clinical experience with long-term treatment results has never been reported for any substance used in orbital floor reconstruction. The purpose of this study was to review our long-term treatment results using Teflon for orbital floor reconstruction following blunt trauma, with emphasis on the incidence of infection, extrusion, and implant displacement. This report presents a 20-year review of 230 Teflon implants for reconstruction of traumatic orbital floor defects. With a mean follow-up period of 30 months, there was only one implant infection and no complications of extrusion or implant displacement. These findings support the use of Teflon as a safe and effective material for the reconstruction of orbital floor defects following blunt facial trauma.     

Long-term use of polyurethane breast prostheses: a 14-year experience

I have used polyurethane prostheses for the past 14 years, implanting 220 implants into 130 patients who desired breast reconstruction after subcutaneous mastectomy or cancer ablation or simply breast augmentation. I theorize that a polyurethane-covered implant resists contracture, retaining its compressibility because the fibroblasts proliferate into the polyurethane in many different directions. When the fibrils contract, the forces of contracture counterbalance one another, resisting contracture. However, when smooth prostheses are implanted, fibrils are directed in a circular fashion around the implant and naturally contract, leading to firmer breasts. There were 115 prostheses inserted following subcutaneous mastectomy, and 22 percent developed contracted capsules. Seven implants became exposed because of skin necroses; one was removed because of a Staphylococcus infection; and two patients developed a combination of polyurethane and silicone granulomas. These developed only with the earlier implant, where there was shedding of the polyurethane sponge layer and silicone bled from the low-viscosity silicone used in the earlier implants. No granulomas were noted with the currently used Surgitek Replicon implant. Eighty-five breasts were reconstructed after cancer ablation with polyurethane implants, and the contracture rate was 2.3 percent. Other complications were minimal. A smaller group of patients had augmentation mammaplasty, and 20 prostheses were placed in 10 patients. A 15 percent contracture rate was noted in this group. In this study, 82 percent of patients were followed for up to 14 years. Capsular contractures occurred in 30 implants between 1 and 11 years, for an average recurrence at 6.3 years. The overall contracture rate was 13 percent. Other complications were minimal. All implants were placed subcutaneously or subglandularly, and all were drained.     

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.     

Resorbable PLLA-PGA plate and screw fixation in pediatric craniofacial surgery: clinical experience in 1883 patients

The need to provide rigid bony fixation in the surgical treatment of craniofacial deformities has inspired an on-going evolution of surgical innovations and implants. Because of the young age of many treated craniosynostosis patients and the unique pattern of cranial vault growth, the extensive implantation of metal devices is potentially problematic. The use of resorbable plate and screw devices offers all of the benefits of rigid fixation without many of their potential risks. Since the introduction of resorbable plate and screw devices in 1996, tens of thousands of craniofacial patients have received implants, but long-term results from a large series have yet to be reported. A combined prospective and retrospective analysis was done on 1883 craniosynostosis patients under 2 years of age treated by 12 surgeons from seven different geographic locations over a 5-year period who used the same type of resorbable bone fixation devices (poly-L-lacticpolyglycolic copolymer). Specifically, the incidence of postoperative infection, fixation device failure, occurrence of delayed foreign-body reactions, and the need for reoperation resulting from device-related problems were determined. Technical difficulties and trends in device use were also noted. From this series, significant infectious complications occurred in 0.2 percent, device instability primarily resulting from postoperative trauma occurred in 0.3 percent, and self-limiting local foreign-body reactions occurred in 0.7 percent of the treated patients. The overall reoperation rate attributable to identifiable device-related problems was 0.3 percent. Improved bony stability was gained by using the longest plate geometries/configurations possible and bone grafting any significant gaps across plated areas that were structurally important. The specific types of plates and screws used evolved over the study period from simple plates, meshes, and threaded screws to application-specific plates and threadless push screws whose use varied among the involved surgeons. This report documents the safety and long-term value of the use of resorbable (LactoSorb) plate and screw fixation in pediatric craniofacial surgery in the infant and young child. Device-related complications requiring reoperation occurred in less than 0.5 percent of the implanted patients, which is less frequent than is reported for metallic bone fixation. Resorbable bone fixation for the rapidly growing cranial vault has fewer potential complications than the traditional use of metal plates, screws, and wires.     

Optimizing autologous breast reconstruction in thin patients

Breast reconstruction with a transverse rectus abdominis myocutaneous (TRAM) flap plus an implant has been proposed as an option for women with a thin body habitus who do not have sufficient abdominal tissue to permit reconstruction with a TRAM flap alone. The standard autologous tissue reconstructive procedure in these women is a combined latissimus dorsi myocutaneous flap and breast implant. We reviewed our experience performing TRAM flap/implant and latissimus dorsi flap/implant breast reconstruction to compare complication rates and aesthetic outcomes between these two types of reconstruction. Between 1992 and 1999, 88 breasts were reconstructed at our institution using an autologous tissue flap combined with a breast implant (44 with a TRAM flap/implant and 44 with a latissimus dorsi flap/implant). Recipient-site and donor-site complications for the two procedures were compared using Fisher's exact test; a panel of unbiased, blinded judges compared the aesthetic outcomes. The recipient-site complication rate was lower for the TRAM flap/implant group than for the latissimus dorsi flap/implant group (18 percent versus 34 percent, p = 0.09). Most recipient-site complications in the TRAM flap/implant group were related to fluid collection around the implant. In the TRAM flap/implant group, complications occurred in 37 percent of the reconstructions that had immediate implant placement and in none of the reconstructions with delayed implant placement (p = 0.01). In the TRAM flap/implant reconstructions with immediate implant placement, the recipient-site complication rate was 50 percent when implants were completely filled with saline, but no complications occurred with incompletely filled, postoperatively adjustable implants (p = 0.03). No microvascular complications occurred with immediate placement of breast implants under TRAM flaps. Donor-site complications included a hematoma, a seroma, and an umbilical necrosis in the TRAM flap/implant group and six cases of seroma formation in the latissimus dorsi flap/implant group. The comparison of aesthetic outcome was statistically significant for the TRAM flap/implant group, which had a higher overall mean score than the latissimus dorsi flap/implant group did (3.29 versus 2.85, p = 0.01). The results of this study suggest that the TRAM flap/implant breast reconstruction should be considered as an alternative to the latissimus dorsi flap/implant breast reconstruction in women with a thin body habitus.     

Aesthetic and restorative midface lifting with hand-carved,expanded polytetrafluoroethylene orbital rim implants

The midface lift represents an important advance in aesthetic and reconstructive surgery. However, the need for reliable fixation along the orbital rim has been a significant challenge. Furthermore, volume is needed at the orbital rim, to compensate for long-term remodeling of the bone of the orbital rim and malar face. A technique using a hand-carved, expanded polytetrafluoroethylene implant that is permanently anchored to the orbital rim with titanium microscrews, creating a site for fixation of the advanced midface soft tissues, was developed. This report presents a retrospective, uncontrolled, case series of 41 consecutive patients who underwent transconjunctival midface operations with these implants, and it addresses a variety of midface aesthetic and reconstructive deficits. Only patients with at least 6 months of follow-up data were included in the study. To date, significant complications have been limited. The complications included two cases of implant palpability, with only one requiring surgical modification. One patient underwent implant removal because of skin breakdown and infection related to recurrent squamous cell carcinoma. One patient required revisional lateral canthoplasty for reasons of symmetry. On the basis of this series, hand-carved, expanded polytetrafluoroethylene implants seem to have significant advantages, compared with previously available orbital rim implants. These advantages include the ability to easily modify the implant for the individual anatomical needs, the creation of a secure anchor for fixation of advanced midface soft tissues, excellent tolerance of the implant material, and the ability to place the implant with limited exposure. The greatest disadvantage is the need for the surgeon to carve the implant, which requires time and carving skill. Despite this limitation, the technique is promising.     

Long-term results of MISTI gold breast implants: a retrospective study

MISTI Gold breast implants (Bioplasty, St. Paul, Minn.) filled with polyvinylpyrrolidone-hydrogel were developed as a promising alternative to silicone-filled implants. Some studies have reported on the positive effects of the implant, such as improved radiolucency and biocompatibility of the gel; however, there are also reports that such implants increased in volume and were subject to capsular contracture in the human body, resulting in demands for their removal. The purpose of this retrospective study was to analyze the long-term results of a series of patients with MISTI Gold breast implants. Between 1991 and 1993, the authors inserted 83 MISTI Gold implants in 61 patients with an average age of 46 years (range, 16 to 69). The authors were able to follow up 48 patients with 71 MISTI Gold implants. The average follow-up was 68 months (range, 10 to 108 months). The retrospective study found that 59 percent of all MISTI Gold implants were removed after an average period of 4.14 years. The main reason for implant removal was an increase in volume of 38 percent, followed by capsular contracture in 14 percent of all 71 MISTI Gold implants. The average increase in volume of all removed MISTI Gold implants was 43 percent. Capsular contracture was graded as Baker I and II in 63 percent and as Baker III and IV in 37 percent. In conclusion, the authors believe that MISTI Gold implants do not fulfill the criteria of safe breast implants, and they agree with the December of 2000 opinion of the Medical Devices Agency of the Department of Health in London that the hydrogel-filled breast implants should not be used until more information about the filler material and its metabolic fate is available.     

Long-term health status of Danish women with silicone breast implants

Long-term safety data are important in the evaluation of possible adverse health outcomes related to silicone breast implants. The authors evaluated long-term symptoms and conditions and medication use among 190 Danish women with cosmetic silicone breast implants compared with 186 women who had undergone breast reduction surgery and with 149 women from the general population. Breast implant and reduction surgeries were performed from 1973 to 1988 at one public hospital and one private plastic surgery clinic. Among women with breast implants, the average implantation time was 19 years, 60 percent (n = 114) had only one implantation, and 10 percent (n = 19) had undergone explantation before the time of study (1997 to 1998). The authors found no material differences in self-reported diseases or symptoms among study groups, except for breast pain, which was reported nearly three times as often by women with implants than by women with breast reduction (odds ratio, 2.8; 95 percent confidence interval, 1.4 to 5.3). Approximately 80 percent of women in each study group reported at least one symptom. No consistent differences were observed in the seroprevalences of antinuclear antibodies or other autoantibodies. Self-reported use of psychotropic drugs was higher among women with breast implants than among either control group. The authors conclude that long-term cosmetic breast implantation may cause capsular contracture and breast pain but does not appear to be associated with other symptoms, diseases, or autoimmune reactivity. The authors' finding of excess use of drugs for treatment of depression and anxiety among women with breast implants may warrant further investigation.     

Long-term comparison of a newly designed gold implant with the conventional implant in facial nerve paralysis.

Patients with complete facial nerve palsy are at risk for eye complications resulting from exposure of the cornea and loss of the blinking reflex. Failure of protection predisposes the patient to exposure keratitis, corneal abrasion and, in rare cases, blindness. The mainstays of non-surgical therapy are cumbersome, obscure vision, and are mostly helpful in patients with acute facial paralysis in whom recovery of orbicularis oculi function is expected. Methods of lid-loading using metal implants and gold eyelid weights have been reported in the literature. Between October of 1988 and March of 1995, 32 patients with lagophthalmos due to facial nerve palsy underwent a total of 34 procedures for the insertion of a gold eyelid weight. Each patient had a gold weight inserted into a small pocket between the orbicularis oculi and the tarsal plate of the upper eyelid. The gold implant is curved to fit the curvature of the eye and contains holes for fixation to the tarsus with sutures. Ingrowth of fibrous tissue through the holes may also help fix the weight in position. Between 1988 and 1991, 10 patients received 10 commercially available rectangular gold implants with 2 holes; these implants resulted in adverse effects, such as infection and exposure in up to 30 percent of the cases. Because of the high complication rate with the rectangular gold implant, the authors began using a new, elliptical gold implant with 3 holes, which is longer, thinner, wider in the center, and narrower in the peripheral portion. This new elliptical implant was used on 22 patients (24 implants) from December of 1991 through March of 1995. The mean follow-up time for the 32 patients in the study was 41.3 months (range, 6 to 63 months), 49.8 months for patients with rectangular implants and 32.8 months for patients with elliptical implants. The elliptical gold implant resulted in dynamic closure of the eyelid and in excellent protection and cosmesis. Lagophthalmos and exposure keratitis resolved, visual acuity significantly improved without complications, and most patients could dispense with eyedrops and salves. A lower eyelid supporting procedure (conchal cartilage graft) should be performed simultaneously in patients with lagophthalmos of a moderate or severe degree to achieve complete closure of the eyelid. Use of a tall pillow decreased the incidence of eyelid opening during sleep. Double eyelid fold operations'were performed on the contralateral eyelid after 6 months, resulting in a symmetrical and beautiful eyelid.     

Aesthetic augmentation of the malar-midface structures

Based on extensive experience with bone grafts for augmentation of the midface-malar region, an implant design has been developed using Proplast. After careful preoperative assessment, a very specific surgical method, described herein, allows precise implant positioning without the need for suture fixation. In many instances, the 6-mm implant can be inserted unchanged. One-hundred and six patients have been operated on using 176 implants over the past 6 years. There were four unilateral infections (2.3 percent of implants and 3.8 percent of patients). None had permanent motor or sensory nerve problems. Fifteen implants (8.5 percent) in 12 patients (11.3 percent) were either removed or repositioned. In those having augmentation for entirely aesthetic reasons, 3 of 60 patients (5.0 percent) required implant removal or repositioning. The incidence of needing to remove or reposition implants has decreased as the technique has evolved.     

Prevalence of silicone breast implant rupture among Danish women

The durability of silicone gel-filled breast implants is of concern, but there are few epidemiological studies on this issue. To date, most of the relevant findings are derived from studies of explantation, which suffer from bias by including women with symptoms or concerns about their implants. As part of a long-term magnetic resonance imaging study of the incidence of rupture, this study involved 271 women with 533 cosmetic breast implants who were randomly selected from among women who underwent cosmetic breast implantation from 1973 through 1997 at one public and three private plastic-surgery clinics in Denmark. The prevalence of rupture was determined from the first magnetic resonance screening. The images were evaluated by four independent readers, using a standardized, validated form. The outcomes under study were rupture, possible rupture, and intact implant. Ruptures were categorized as intracapsular or extracapsular. Overall, 26 percent of implants in 36 percent of the women examined were found to be ruptured, and an additional 6 percent were possibly ruptured. Of the ruptured implants, 22 percent were extracapsular. In multiple regression analyses, age of implant was significantly associated with rupture among second- and third-generation implants, with a 12-fold increased prevalence odds ratio for rupture of implants that were between 16 and 20 years of age, compared with implants between 3 and 5 years of age. Surgitek implants (Medical Engineering Corporation, Racine, Wis.) had a significantly increased prevalence odds ratio of 2.6 for rupture, compared with the reference implants. No significant association was found with the position (subglandular or submuscular) or the type of implant (single- or double-lumen). Extracapsular ruptures were significantly associated with a history of closed capsulotomy (p = 0.001). In the future, the authors plan to examine the women in their cohort with a second magnetic resonance imaging scan to establish the incidence of rupture, a parameter unknown to date in the literature, and to further characterize those factors associated with the actual risk of rupture.     

Infectious complications following breast reconstruction with expanders and implants

The incidence of infection following breast reconstruction with expanders and implants ranges from 1 to 24 percent. Numerous factors associated with infection have been described; however, a one-variable at time setting and multifactorial analysis have not been performed. The purpose of this study was to analyze a set of factors that may predispose women to infection of the expander or implant. Between 1997 and 2000, a total of 168 implant reconstructions were performed in 130 women at a single institution. The mean age for all women was 48.2 years (range, 25 to 77 years). The factors that were analyzed included axillary lymph node dissection, chemotherapy, radiation therapy, tumor stage, timing of implant insertion, number of sides (unilateral versus bilateral), tobacco use, and presence or absence of diabetes mellitus. Statistical analysis was performed with stepwise logistic regression. Mean time to follow-up for all patients was 29 months (range, 12 to 47 months). Infectious complications occurred in 10 women (7.7 percent) and in 10 expanders or implants (5.9 percent). Infected implants were removed an average of 116 days following insertion (range, 14 to 333 days). Cultured bacteria included Staphylococcus aureus and Serratia marcescens. A significant association (p < 0.04) was detected between implant infection and radiation therapy. The chance for implant infection was 4.88 times greater for implants that were exposed to radiation therapy compared with those that were not. In addition, there was suggestive (p < 0.09) evidence that the chance of implant infection following lymph node dissection was 6.29 times higher than when no lymph nodes were removed. No significant association between implant infection and age, diabetes, tobacco use, tumor stage, timing of implant insertion, or chemotherapy was found.     

Methyl prednisolone in double-lumen gel-saline submuscular mammary prostheses: a double-blind, prospective, controlled clinical trial

At the time of immediate breast reconstruction with submuscular implants, 76 consecutive patients (89 breasts) were randomized into two groups. One received a gel-saline, double-lumen implant with 40 cc of saline added to the outer lumen, while the other received the same implant plus 40 cc of saline and 16 mg methyl prednisolone (40 mg%). Patients were followed for a minimum of 3 years. The groups, which were matched for patient age and implant size, were evaluated at 3, 12, 24, and 36 months for capsular contracture, steroid atrophy, and other complications. With completion of the double-blind study, the patients with submuscular gel-saline implants with only saline added had an overall capsular contracture rate of 38 percent at 3 months, 38 percent at 12 months, and 44 percent at 24 and 36 months. Those with methyl prednisolone had an overall capsular contracture rate of 14 percent at 3 months, and this remained unchanged through the end of the study. The rates of all other complications were comparable. Methyl prednisolone in a dose of 16 mg in 40 cc saline (concentration 40 mg%), when used in the outer lumen of a double-lumen gel-saline implant in a submuscular pocket, is both safe and efficacious in reducing the risk of capsular contracture for a minimum of 3 years in patients undergoing immediate breast reconstruction with submuscular mammary implants.     

Trilucent breast implants: voluntary removal following the Medical Device Agency recommendation. Report on 115 consecutive patients

In June of 2000, the U.K. Medical Device Agency recommended the removal of Trilucent implants as a precautionary maneuver in response to reports of local inflammatory reactions. This decision allowed the authors to operate on 115 consecutive patients between June of 2000 and January of 2001. On the preoperative examination, the authors found a very high incidence of rippling (66 percent), whereas capsular contracture was seen in only three patients (2.6 percent). Rippling was significantly more common in patients with subglandular implants. Five implants were found ruptured during the operation. This figure, together with the relative ease of implant breakage at removal, shows a premature deterioration of the implant shell. The authors also comment on implant bleeding, which seems common in this type of breast implant. The authors think that this is a possible cause for the rippling phenomenon, resulting from a reduction of the implant content. On the basis of these findings, the authors conclude that Trilucent implants are associated with a poor cosmetic outcome and a high rate of complications.     

Clinical experience with Heyer-Schulte inflatable implants in breast augmentation

Following breast augmentation, 100 patients with inflatable saline implants were followed for a period of 6 months to 8 1/2 years. Capsular contracture rate, Baker II or greater, was 3.4 percent. This low rate of capsular contracture is attributed to early manipulation of the implant. The deflation rate was also 3.4 percent. The Heyer-Schulte (Mentor) inflatable implant offers an acceptable low rate of leakage to justify its continued use. It also offers an advantage in correction of asymmetries and yields softer breasts. The replacement of an occasional deflated implant does not appear to pose more than a minor nuisance nor to materially compromise the possibility of an excellent long-term result.     

Capsular contracture after breast reconstruction with silicone-gel and saline-filled implants: a 6-year follow-up

A major problem after breast reconstruction with augmentation mammaplasty is contracture of the fibrous capsule around the prosthesis. In a series of 72 breasts in 65 women, silicone-gel and saline-filled implants were randomly selected prior to breast reconstruction. The results were judged with respect to consistency, tenderness, wrinkles, and sounds by two independent plastic surgeons according to the breast augmentation classification (BAC) and by the patients themselves. Capsular contracture was found by the surgeons in 50 percent of the gel implant group and in 16 percent of the saline implant group, which is in conformity with the results of the follow-up 5 years earlier. The incidence of deflation was 16 percent in the saline group and occurred in different sizes of both overinflated and underinflated prostheses. The degree of slow leakage from saline implants will be discussed. Despite the high rate of contractures in the gel group, 85 percent of all patients were satisfied with the result of the reconstruction.     

Patient acceptance of adequately filled breast implants using the tilt test

Adequate fill of any breast implant, regardless of shell characteristics, shape, or filler material, is important to prevent implant shell wrinkling, folding, or collapse that could potentially decrease the life of the implant. Implant shell life is a major factor that affects reoperation rates. The greater the necessity of reoperations, regardless of implant type, the greater the rate of local complications, necessitating additional surgery with additional risks and costs to patients. Palpable shell folding, visible wrinkling or rippling, palpable shifts of filler material, sloshing, and compromised aesthetic results can result from an under-filled implant. Any of these complications can necessitate reoperations with increased risks and costs to patients. This is a study of 609 consecutive patients from January of 1993 to December of 1998 who were given detailed preoperative informed consent and a choice of implant shape and type and who chose the increased firmness associated with an implant that is adequately filled to pass the tilt test. This study addresses two questions: (1) Will patients accept the increased firmness of an implant that is filled to pass the tilt test? and (2) Is adequate fill by the tilt test useful clinically to help reduce the incidence of postoperative rippling, wrinkling, and spontaneous deflation in saline implants? Patients were followed by postoperative examinations and questionnaires. No patient requested implant replacement to a softer implant postoperatively, and no reoperations were performed for visible rippling or wrinkling. The spontaneous deflation rate over this 6-year period was 9 of 1218 implants, or 0.739 percent. If patients will accept more firmness with an adequately filled implant, regardless of the filler material, surgeons might worry less about recommending an adequately filled implant to patients, and manufacturers might feel more comfortable producing adequately filled implants and redefining fill volumes for underfilled implants. More adequately filled implants could potentially reduce risks of reoperations by reducing premature shell failure and shell wrinkling complications.     

Permanent lip augmentation employing polytetrafluoroethylene grafts.

There is a paucity of literature regarding aesthetic enhancement of the lips. This is due to the lack of reliable techniques employing autogenous tissue and the reluctance on the part of surgeons to use an alloplastic implant in this anatomic region, which is superficial, subject to trauma, and must conform to innumerable geometric shapes. The ideal lip augmentation procedure should provide for a predictable, permanent enlargement without visible scars or donor-site deformity, can be customized to the particular patient's anatomy, and can be reversed if so desired. A series of 21 alloplastic lip implants employing polytetrafluoroethylene with a mean follow-up of 14.33 months is presented. The overall complication rate was 9.52 percent. Permanent lip augmentation can be achieved with alloplastic sheet grafts of polytetrafluoroethylene in a safe and predictable fashion. Stiffness of the lips develops with progressive thickness of the grafts. Grafts exceeding 3 mm in thickness should be avoided.