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.     

Use of a temporoparietal fascia-covered silastic implant in nose reconstruction after foreign body removal

A total of 47 consecutive patients with paraffinoma of the nose underwent surgery for paraffinoma removal and insertion of temporoparietal fascia-covered Silastic implants between January of 1990 and June of 1996. There are several advantages to our procedure, and we obtained satisfactory outcomes with it. A bilateral alar rim incision was sufficient for our procedure. The Silastic implant could be sculptured easily, was not absorbed, and produced excellent cosmetic results. The fascia was highly bioadaptable and survived beneath the dermis through revascularization, even in the places where the paraffin material remained. The fascia reinforced the thinned skin that resulted after paraffinoma removal and, therefore, prevented exposure of the Silastic implant. The telangiectasia of paraffinoma of the nose improved in some patients after surgery.     

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.     

Use of external reservoirs in tissue expansion

The use of tissue expanders having external reservoirs is presented. Twenty-four patients had 36 tissue expanders placed in the scalp, face, neck, upper limbs, chest, and lower limbs. All patients, apart from one, were taken to completion. This patient had erosion of the skin over expander and was only partially completed after removal of the expander. Apart from one instance of deflation at the end of the expansion where the skin could still be used, there were no other complications, in particular, no infections. The advantages of this technique are reduced operating time, ease of injection into the reservoir, lack of pain for the patient, early detection of reservoir or filling tube junction leakage, and lack of complications associated with the reservoir. This procedure is not recommended on at least theoretical grounds for breast expansion, where a permanent implant is to be inserted.     

Transaxillary subpectoral augmentation in the ptotic breast: augmentation by disruption of the extended pectoral fascia and parenchymal sweep

A new approach to transaxillary subpectoral breast augmentation based on an understanding of the anatomy of the extended pectoral fascia and the inframammary fold allows for the widespread application of this technique. Previous authors have stated that transaxillary augmentation is only applicable to a small subset of the general population and is contraindicated in mild degrees of ptosis or in large augmentations. The new approach, augmentation by disruption of the extended pectoral fascia technique and the parenchymal sweep maneuver, prevents high-riding implants and double folds. By disrupting the fascia, the lower portion of the implant is able to sit in a partially subglandular rather than subfascial plane. The anatomy and clinical implications of the extended pectoral fascia are discussed, as is the augmentation by disruption of the extended pectoral fascia technique. The parenchymal sweep maneuver is also described. Clinical cases are presented.     

Cytological and functional characteristics of fascia adipocytes in rats: A unique population of adipocytes

The dermal adipocytes, superficial fascia and subcutaneous adipose tissue (SAT) exist in the interspaces between the dermis and muscular fascia. They are adjacent to each other and traditionally recognized as one SAT. Recently, the dermal adipocyte was redefined as a unique population independent from the SAT. Also, we identified a novel type of adipogenic progenitors in rat superficial fascia. This study aimed to examine cytological and functional characteristics of fascial adipocytes in rats. Superficial fascia had no adipocytes in neonatal rats but gradually appeared numbers of adipocytes in growing rats. Adipogenic progenitors were found to reside in fascia and had strong ability in spontaneous and induced adipogenic differentiation in vitro. Differentiated fascial adipocytes versus subcutaneous or visceral adipocytes expressed increased adipose triglyceride lipase but decreased beta-adrenoreceptor, perilipin-1 and hormone-sensitive lipase (HSL), thus having high basal lipolysis but low lipolysis response to catecholamines. Phosphorylation of perilipin-1 and HSL and translocation of HSL to lipid droplets were attenuated in response to catecholamines rather than post-adrenoreceptoral lipolytic stimulators. The results suggested that superficial fascia was an origin of adipocytes with distinct developmental, cytological and functional characteristics. We proposed that fascial adipocytes could be considered as a unique population of adipocytes in the body. The fascia origin of adipocytes as an adipogenic model might logically explain fat neogenesis occurred at anatomical locations where originally exist no adipose tissues and thereby no adipose-derived stromal precursors. Also, the special histoanatomical relations and overlaps between the dermis, superficial fascia, SAT, and their adipocytes were discussed.     

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 synovial metaplasia mimicking silicone leak of a breast prosthesis: a case report

Introduction

Synovial metaplasia around a prosthesis and in particular around silicone breast implants has been noted by various investigators, but has unknown clinical significance. We report on a patient where a large amount of synovial fluid mimicked rupture of an implant. We believe this to be an unusual clinical presentation of this phenomenon. Review of the English language literature failed to identify a comparable case.

Case presentation

A 25-year-old woman had undergone bilateral breast augmentation for cosmetic reasons. One implant was subsequently subjected to two attempts at expansion to correct asymmetry. The patient was later found to have a large quantity of viscous fluid around the port of that same prosthesis. Histological assessment of the implant had consequently confirmed capsular synovial metaplasia. This had initially caused the suspicion of a silicone 'bleed' from the implant and had resulted in an unnecessary explantation.

Conclusion

Capsular synovial metaplasia should be ruled out before the removal of breast implants where a leak is suspected. Manipulation and expansion of an implant may be risk factors for the development of synovial metaplasia.

     

Breast augmentation: choosing the optimal incision, implant, and pocket plane

A retrospective study of 220 patients was performed to review surgical design in breast augmentation. Three specific issues were studied: incision site, implant variables, and pocket plane selection. The influence of these three factors on aesthetic results in both primary and secondary cases was the focus of the analysis. No attempt was made to address long-term issues such as capsular contracture or saline implant deflation rates. In 77 primary augmentation patients and 80 unilateral augmentations for symmetry in breast reconstruction, there were the following untoward results: 11 revisions for unilateral malposition, change to a different implant shape, or change to a larger implant size; four deflations of saline implants requiring replacement; and four conversions of saline to silicone gel implants. In 63 secondary cases, there were two hematomas and two infections requiring implant removal and subsequent replacement. Operative technique in breast augmentation is described, as are recommendations for each of the options associated with the three variables studied.     

Diced cartilage grafts in rhinoplasty surgery

The use of diced cartilage grafts in rhinoplasty surgery was recently revived by Erol with the publication of his technique for "Turkish delight" grafts (i.e., diced cartilage grafts wrapped in Surgicel). The present study details the authors' experience with 50 consecutive diced cartilage grafts used in three configurations during a prospective study of 50 primary and secondary aesthetic rhinoplasty procedures performed by the senior author (Daniel). Part I consists of 22 diced cartilage grafts wrapped in Surgicel and placed in the radix (n = 14), radix/upper dorsum (n = 4), and full-length dorsum (n = 4). All grafts were performed adhering meticulously to Erol's technique without modification. This portion of the study was halted abruptly at 4 months because of the unexpected absorption and clinical failure of all diced cartilage grafts wrapped in Surgicel. Subsequently, five patients had revision surgery, and biopsy specimens were taken at the prior grafting site and analyzed histologically. After this clinical failure, part II of the study began, consisting of 20 patients who had diced cartilage grafts wrapped in fascia. The range of applications was comparable: radix (n = 12), radix/dorsum (n = 3), and full-length dorsum (n = 5). Because of our prior practice of overcorrecting by 20 percent with diced cartilage grafts wrapped in Surgicel, we had excessive amounts of material in six of our initial diced cartilage wrapped in fascia radix grafts, but no subsequent grafts. The overcorrections were easily reduced at 6 weeks to 11 months postoperatively using a pituitary rongeur under local anesthesia, and the material was sent for histologic analysis. Minimum 1-year follow-up of all 20 cases has shown maintenance of the grafts without evidence of absorption. Part III of this study comprised eight patients who had diced cartilage grafts without a fascial covering placed throughout the nose, including on the sides of osseocartilaginous rib grafts to the dorsum. At 14 months, there was no evidence that any of these grafts had been absorbed. Histologic analysis of the biopsy specimens from the diced cartilage grafts wrapped in Surgicel showed evidence of fibrosis and lymphocytic infiltrates with small amounts of Surgicel visible on birefringent microscopy. Remnants of cartilage were present but were metabolically inactive on the basis of negative glial fibrillary acidic protein staining. Control specimens of fresh septal cartilage and banked septal cartilage were remarkably similar to each other and demonstrated normal cartilage architecture and cellular activity. The diced cartilage grafts wrapped in fascia showed coalescence of the diced cartilage into a single cartilage mass, with viable cartilage cells and normal metabolic activity on the basis of glial fibrillary acidic protein staining. All of the diced cartilage grafts wrapped in Surgicel absorbed and failed to correct the clinical problem for which they were performed. All of the diced cartilage grafts wrapped in fascia and pure diced cartilage grafts did correct the clinical deformities and appear to have survived completely. The diced cartilage grafts wrapped in fascia placed along the dorsum were distinctly palpable throughout the postoperative period, as was one prior case with a 6-year follow-up. The authors' clinical experience confirms the experimental studies of Yilmaz et al. that question the use of Surgicel for wrapping diced cartilage grafts in clinical rhinoplasty surgery.     

Angiogenesis and VEGF-expressing cells are identified predominantly in the fascia rather than in the muscle during the early phase of dermatomyositis

Background

We previously demonstrated that fasciitis is a common lesion in dermatomyositis (DM) and that DM-associated fasciitis is detectable, as the result of the increased vascularity in the fascia, by power Doppler ultrasonography. We aimed to investigate whether angiogenesis and vascular endothelial growth factor (VEGF)-expressing cells in the fascia are histologically demonstrated during the early phase of DM, and whether inflammation is involved in angiogenesis and an increased number of VEGF-expressing cells.

Methods

We prospectively evaluated 22 patients with DM and 11 patients with polymyositis (PM). Immunohistochemical staining for CD31, VEGF, and tumor necrosis factor-α (TNF-α) were performed on paraffin-embedded sections. The total vascular inflammation score (TVIS), angiogenesis score (AS), and numbers of VEGF-expressing and TNF-α-expressing cells were analyzed in the fascia and muscle.

Results

Significant fasciitis was detected in most of the patients DM with or without myositis-specific/associated antibodies, while mild fasciitis was detected in four patients with PM, two of whom were positive for anti-aminoacyl-tRNA synthetase (anti-ARS) antibodies. The AS and the number of VEGF-expressing cells in the fascia of patients with DM were significantly greater than those of patients with PM; no significant difference was observed in muscle in patients with DM and PM. The number of VEGF-expressing cells in the fascia correlated with the AS of DM patients. In early-phase DM, the AS, the number of VEGF-expressing cells, and the TVIS in the fascia were significantly higher than in muscle. However, no significant differences were observed in these scores excluding the TVIS between muscle and the fascia in late-phase DM. In DM patients, the TVIS correlated with the AS in the fascia, while the number of TNF-α-expressing cells correlated with the TVIS and the number of VEGF-expressing cells in the fascia.

Conclusion

Angiogenesis, the number of VEGF-expressing cells, and the degree of inflammation were higher in the fascia in DM than in PM, and were increased predominantly in the fascia rather than in the muscle in early-phase DM. The degree of inflammation correlated with that of angiogenesis in the fascia of DM. The fascia can therefore be a primary site of inflammation and angiogenesis in the pathogenesis of DM.

     

Effects of lung volume and alveolar surface tension on pulmonary vascular resistance

Utilizing the arterial and venous occlusion technique, the effects of lung inflation and deflation on the resistance of alveolar and extraalveolar vessels were measured in the dog in an isolated left lower lobe preparation. The lobe was inflated and deflated slowly (45 s) at constant speed. Two volumes at equal alveolar pressure (Palv = 9.9 +/- 0.6 mmHg) and two pressures (13.8 +/- 0.8 mmHg, inflation; 4.8 +/- 0.5 mmHg, deflation) at equal volumes during inflation and deflation were studied. The total vascular pressure drop was divided into three segments: arterial (delta Pa), middle (delta Pm), and venous (delta Pv). During inflation and deflation the changes in pulmonary arterial pressure were primarily due to changes in the resistance of the alveolar vessels. At equal Palv (9.9 mmHg), delta Pm was 10.3 +/- 1.2 mmHg during deflation compared with 6.8 +/- 1.1 mmHg during inflation. At equal lung volume, delta Pm was 10.2 +/- 1.5 mmHg during inflation (Palv = 13.8 mmHg) and 5.0 +/- 0.7 mmHg during deflation (Palv = 4.8 mmHg). These measurements suggest that the alveolar pressure was transmitted more effectively to the alveolar vessels during deflation due to a lower alveolar surface tension. It was estimated that at midlung volume, the perimicrovascular pressure was 3.5-3.8 mmHg greater during deflation than during inflation.     

Capsular contracture in silicone gel and saline-filled breast implants after reconstruction

Comparisons between results with randomly allotted silicone-gel and saline-filled prostheses in breast reconstruction after mastectomy led to the following conclusions. Neither prosthesis type is ideal. Leakage from saline-filled implants occurred in 2 of the 37 implants, with resultant deflation. Silicone prostheses had a significantly higher rate of capsular contracture [surgeon's evaluation: 54 percent capsular contracture for silicone-gel compared with 20 percent for saline-filled prostheses (p = 0.006); patients' evaluation for the same figures: 54 percent compared with 29 percent (p = 0.03)]. Other authors have shown the presence of silicone in the tissue around silicone-gel-filled silicone implants, but less or none around saline-filled silicone implants. Since the only difference between the two groups was the randomly allotted implants, we assume that the free silicone around silicone-gel-filled prostheses is the major cause of capsular contracture. Since the saline-filled implants showed a 20 percent capsular contracture rate, there could be other causes of capsular contracture in this study. For prevention of contracture, improved implant encapsulation and use of a less reactive filling substance seem to offer possibilities. Surgical technique should aim to preserve the integrity of the prosthesis.     

Rate and incidence of capsular contracture: a comparison of smooth and textured silicone double-lumen breast prostheses

Capsular contracture results in dissatisfaction and deformity among the 2 million women who have had silicone implants. The literature describes contracture rates as high as 74 percent. I present a comparison of rates and incidences of contracture in patients augmented with smooth and textured double-lumen silicone implants. A total of 165 "smooth" and 63 "textured" implant patients were included in this study, which spans 12 years, 1978-1990. All patients underwent bilateral aesthetic augmentation performed by the same surgeon. Of the 165 smooth implant patients, 74 (44.8 percent) experienced contractures requiring treatment. Of the 63 textured implant patients, 3 (4.8 percent) previous contracture patients experienced sudden fibrosis within 3 months. All others remained soft. It appears that deeply textured silicone surfaces delay or decrease the rate and incidence of clinical capsular contracture, at least for 2 years.     

Dermatan sulfates of normal and scarred fascia

We evaluated the composition of dermatan sulfates (DS) derived from 23 samples of normal and 23 samples of scarred fascia lata. We analyzed the molecular weight of intact DS chains and the length of chain regions comprising: (1) clusters of L-iduronate-containing disaccharides ("iduronic sections"); (2) clusters of D-glucuronate-containing disaccharides ("glucuronic sections"); and (3) copolymeric sections with both types of disaccharides. A portion of scarred fascia DS chains demonstrated higher molecular weight compared with those from normal tissue. Most disaccharides of DS chains derived from both fascia types form copolymeric segments - heterogeneous in size - with alternatively distributed single disaccharides with glucuronic residues and mainly single ones with iduronate. Only a small number of disaccharides form "glucuronic sections" of heterogeneous size or short "iduronic sections". However, the scarred fascia DS chains demonstrate an increased content of shorter "glucuronic sections" and shorter, often oversulfated, copolymeric segments. It seems that in normal fascia, the DS chain type with a single, long copolymeric region and a single, shorter "glucuronic section" is predominant, while in scarred tissue an increase in multidomain DS chain content may occur.     

Bangkok Biomaterial Center: 15 Years Experience in Tissue Banking

Tissue banking is started in Thailand in 1979 at the Department of Orthopaedic Surgery, Siriraj Hospital, Bangkok. At that time tissues produced were freeze-dried bone allografts which were sterilized by ethylene oxide. In 1984, the freeze-dried tissue allograft project received an award from the National Research Council of Thailand. The Bangkok Biomaterial Center was officially inaugurated on December 6, 1984 under the Royal Patronage of H.R.H. Princess Galyanivadhana and is located inside the Siriraj Hospital. The Center is involved in the procurement, processing, storage and development of bone and tissue allografts. A variety of allografts including bone, cartilage, fascia lata, dura mater, cornea and also cardiovascular tissues have been procured and processed. Preservation and long-term storage are accomplished by freeze drying and deep freezing. Grafts prepared by the Center are supplied free of charge at the request of surgeons in hospitals throughout Thailand and in neighboring countries. The Center acts as the National Tissue and Allograft Bank of Thailand. From December 1984 to February 2000, the Center has processed a total of 20524 allografts: 16981 freeze-dried bones, 705 deep-frozen bones, 1838 freeze-dried amnion, 559 freeze-dried dura mater, 342 freeze-dried fascia lata, 46 costal cartilage, 18 corneas, 2 skin, 5 trachea, 22 fresh tendon and 6 bone substitutes. The allografts processed were used in 2049 patients by 223 surgeons in 53 hospitals in Thailand and 4 cases in neighboring countries. There have been 413 cadaveric donors, 619 living donors, 16 brain dead donors and 270 graveyard donors. There have been complications in 126 patients (6.14%) due to various clinical conditions. There have been production and application of 4 hydroxyapatite occular implant by the Center. The Center is in the process of establishing a full-fledged Research, Clinical and Cell Culture Laboratory.     

Abdominal wall partitioning (the accordion effect) for reconstruction of major defects: a retrospective review of 10 patients

Ten patients underwent abdominal wall reconstruction using the technique of abdominal wall partitioning. All defects were closed in the midline by approximating fascia to fascia with the assistance of a general surgeon. One patient had skin grafted small bowel. Five patients had chronically infected mesh and previous failed attempts at repair. Four patients had large ventral hernias following gastric reduction operations and massive weight loss. No defect in any dimension was less than 20 cm. All patients had secure abdominal wall repair by reconstruction of a midline anchor for the abdominal wall musculature. One patient was lost to follow-up after 3 weeks. The average follow-up time for the remaining nine patients was 18.6 months (range, 6 months to 4.7 years). One patient required readmission to the hospital for management of a limited area of skin necrosis. Two patients had minor wound infections, and three patients had subcutaneous seromas, all of which were managed on an outpatient basis. One patient developed a 2 x 2-cm subxiphoid hernia recurrence. Technical details include subcutaneous undermining of the abdominal skin to the anterior axillary lines bilaterally, mobilization of the viscera to expose the white lines of Toldt bilaterally, and parallel, parasagittal, staggered releases of the transversalis fascia, transversalis muscle, external oblique fascia, external oblique muscle, and rectus fascia. These multiple releases allow expansion and translation of the abdominal wall by an accordion-like effect. This accordion-like effect allows closure of abdominal wall defects that are substantially larger than what can be closed with current techniques.