Saline Implants Research Articles

The Pocket Protector: A New Breast Implant Device

Introduction: Although strides have been made to improve breast augmentation surgery, they have focused on the use of single implant devices, necessitating adjustments to the type of operation performed and implants used. And although some breast types obtain excellent results, many others are less than optimal. By developing a thin synthetic expanded polytetrafluoroethylene device, the Pocket Protector, that lines the breast pocket by integrating with the body without a capsule formation, smooth-surfaced gel (or saline) implants can remain soft and provide improved augmentation mammoplasty results. Even patients with Baker class III and IV breasts refractory to all types of revisional surgery can achieve soft, natural breasts after revision with the Pocket Protector. Materials and Methods: Augmentation mammoplasty and revision mammoplasty, often with capsulectomy, with the Pocket Protector was performed on 38 patients with smooth gel or saline implants. Since the initial prototype in April 1995, data have been collected with each patient to evaluate the efficacy of this device. Results: Patients involved in the current study have yielded soft, natural-feeling breasts in the normal anatomic position. Two patients who experienced a flu syndrome in the immediate postoperative period developed refractory seromas necessitating removal of the expanded polytetrafluoroethylene. Both cases have subsequently been successfully revised with Pocket Protectors and smooth-gel implants. Three patients with very thin tissues experienced rippling in spite of using smooth-gel implants. Discussion: The net result yields a soft, ripple-free (or near ripple-free) breast. Additionally, gel implants inside the Pocket Protector are potentially shielded from the body, should the implants rupture. Implants are easily exchangeable if necessary without need for capsulectomy or capsulotomy. The Pocket Protector may also represent an implant device appropriate to treat breasts refractory to traditionally attempted augmentations, such as subcutaneous mastectomy. Although the first case performed in April 1995 has remained successful, most of the experience has been gathered over the past year. This preliminary paper presents the experience with the past 38 cases.

Breast Augmentation: Cancer Concerns and Mammography-A Literature Review.

There has been a longstanding concern about whether there is an association between breast cancer and breast implants. This concern has served as the stimulus for many studies. Although there are data to support both sides, after our critical review of the literature, several conclusions can be drawn. (1) Augmented patients are not at a greater risk than the nonaugmented population for developing breast cancer. (2) Early detection of occult cancer is possible in augmented patients. (3) Submuscular placement allows for greater mammographic visualization. (4) Eklund views (displacement techniques) should be used when obtaining mammograms in augmented patients and should be interpreted by radiologists experienced in the evaluation of augmented patients. (5) Silicone and saline implants demonstrate the same radiodensity on mammograms; neither is superior to the other. (6) The current recommendations for getting screening/preoperative mammograms are no different for augmented patients, although the ultimate decision lies with each surgeon and patient.

Prospective analysis of the outcome of subpectoral breast augmentation: sensory changes, muscle function, and body image.

This study is a prospective analysis of the outcome of subpectoral breast augmentation. Forty-seven patients undergoing breast augmentation were studied. They were assessed for pectoralis muscle function, breast sensation, and body image before and after subpectoral breast augmentation with saline implants. The patients were evaluated as follows: Pectoralis function was determined by measuring maximal voluntary isometric force. Sensation was evaluated by two means: vibration and pressure. The patient's body image was assessed using the Multidimensional Body-Self Relations Questionnaire. Results indicated a significant change in breast sensation at 3 months postoperatively but not at 6 months. Pectoralis muscle function did not significantly change during the study period. Body image was significantly improved at both postoperative measuring periods. The authors conclude that breast augmentation results in improved body image with negligible effect on muscle or nerve function.

Indications and practical applications for high-profile saline breast implants

Background High-profile round saline breast implants that permit a better match of implant diameter to the base diameter of the breast are now available. Objective The advantages and disadvantages of high-profile breast implants are defined from the point of view of the author's initial experience. Methods The maximal optimal breast implant was determined on the basis of preoperative measurements, with emphasis on breast base diameter. Patients selected implant size using trial implants in a bra of the desired cup size. The implant profile with the best match to breast base diameter at the selected size range was used. Results Sixty-seven patients, of a total of 164 patients who received saline breast implants during a 14-month period, received high-profile breast implants. Conclusions High-profile saline implants provide a useful option for the patient who desires an implant size that exceeds the natural breast base diameter in standard profiles. Rippling may be diminished in these cases. A more conical shape may be achieved in cases of periareolar mastopexy with augmentation. Disadvantages of the high-profile design include less mobility of the implant and a less obtuse transition from the chest to the upper breast compared with results achieved with standard round implants.

Chemically assisted capsulectomy in the rabbit model: a new approach.

Capsular contracture remains the most common adverse sequela of aesthetic and reconstructive breast surgery when breast implants are used. Capsulectomy may be technically difficult and can result in damage to the neighboring tissues. The aim of this study was to verify the efficacy of sodium 2-mercaptoethane sulfonate (mesna) as a facilitator of periprosthetic dissection when instilled locally at the time of capsulectomy. Two 40-cc textured saline implants were placed dorsally into each of 20 rabbits. After 5 months, capsulectomy was performed after the removal of the implants. Mesna was used to highlight the junction between scar and normal tissue and to help separate the tissues during the capsulectomy in one of the two capsules in each rabbit. Saline was used for the same purpose in the other. The blood loss, duration of operation, and difficulty of dissection as experienced by the surgeon were recorded during the course of the operation. The capsules were also examined histologically for their thickness and graded according to their degree of intactness at the conclusion of the procedure. The histological grading based on the intactness of the removed capsule (p = 0.005), the operating time (p = 0.003), and the subjective evaluation of the difficulty of the procedure (p = 0.003) were significantly better in the mesna group. There was no significant difference in the blood loss between the two groups. Because of its ability as a chemical dissector, mesna may be a useful aid in capsulectomy. Clinical studies to confirm this evidence are required.

The effectiveness of sodium 2-mercaptoethane sulfonate (mesna) in reducing capsular formation around implants in a rabbit model.

The development of capsular contracture is the most common complication associated with the insertion of breast implants. The authors studied the role of sodium 2-mercaptoethane sulfonate (mesna) in reduction of capsular formation in a rabbit model. Two 40-cc textured saline implants were placed dorsally into each of the 20 rabbits in the study. At the time of insertion of the implants, 10 ml of a 10% solution of mesna was instilled into one of the pockets and normal saline was instilled into the other. The implants were removed and a capsulectomy was performed at 5 months. The capsules were examined histologically for qualitative differences between the two groups. Quantitative analysis of the thickness of the capsule and the myofibroblast populations was also performed and compared between the two groups. The mean total thickness of the capsule around the implants was 496.8 microm in the mesna-treated group compared with 973.7 microm in the saline-treated group (p < 0.001). Likewise, the thickness of the myofibroblast layer was reduced in the mesna-treated group at 283.2 microm versus 555 microm in the saline-treated group (p < 0.0001). The capsules were also relatively less vascular in the mesna-treated group. Because of its ability to reduce the extent of capsular formation and to diminish development of myofibroblasts in the capsules, mesna would appear to be a useful adjunct in the prevention of capsular contracture formation.

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.

Tissue expansion after inverted-T mammaplasty: can it be performed successfully?

Breast cancer patients will occasionally need to undergo mastectomy after previous reduction mammaplasty or mastopexy. The presence of the "inverted-T" scar presents a unique reconstructive dilemma: Do mastectomy flaps that are traversed by surgical scars still allow for adequate tissue expansion and a good aesthetic result? The objective of this study was to evaluate the authors' experience with tissue expansion/implant reconstruction in patients with an inverted-T scar. All patients who underwent tissue expansion and implant reconstruction after inverted-T mammaplasty were reviewed retrospectively to determine aesthetic results, patient satisfaction, and complication rates associated with this reconstructive technique. During a 6-year period (1995-2001), 11 patients (12 breasts) underwent breast reconstruction with tissue expansion and implant placement after either reduction mammaplasty (N = 8) or mastopexy (N = 4). All patients reached target expansion volumes. After successful tissue expansion, exchange to either saline (N = 7) or silicone (N = 5) implants was performed. The mean follow-up period after implant exchange was 18.5 months (range, 2-72 months). Complications were minimal and included partial flap necrosis (N = 1). Aesthetic appearance and symmetry were judged to be good or excellent in the majority of patients. Overall patient satisfaction was high. Tissue expansion with implant exchange is an effective reconstructive technique for mastectomy defects after previous inverted-T mammaplasty. In this series, good to excellent aesthetic results were achieved in the majority of patients with minimal associated complications.

Protocol for retrieval and analysis of breast implants.

The Center for Implant Retrieval and Analysis has been established at Washington University's Division of Plastic and Reconstructive Surgery for the purpose of studying implantable devices retrieved after surgery or autopsy and assessing their condition after implantation. Since the early 1990s, significant experience has been gained in testing and analyzing silicone gel breast implants and, to a lesser extent, saline-filled devices. However, there has been no systematic method reported for collecting and evaluating these implants in a way that would permit different laboratories to compare their data. This article offers the plastic and reconstructive surgery community a standardized protocol for analyzing explanted silicone gel and saline-filled breast implants. The protocol gives surgeons a clearly defined approach for removing, handling, documenting, and shipping explanted breast implants. At the same time, biomaterials researchers can use the protocol to acquire implant data with reliable and reproducible methods. Because the study of saline implants has lagged behind the study of silicone gel implants, the article concludes with a demonstration of how this protocol can be applied to obtain mechanical properties data and use scanning electron microscopy to illuminate failure mechanisms of saline devices, including three explants removed after 20+ years in vivo.

The Evolution of Breast Implants

The present review traces the evolution of breast implants over the past 50 years. During the early years (from 1951 to 1962), a number of different sponges were used for breast augmentation. The first of these was Ivalon, a polyvinyl alcohol sponge. Other sponges were introduced subsequently, including Etheron (a poly-ether sponge popularized by Dr Paule Regnault in Montreal) and Polystan (fabric tapes that were wound into a ball). Subsequently, polyethylene strips enclosed in a fabric or polyethylene casing were also used for breast augmentation. All of these materials had similar outcomes. Although the initial results were encouraging, within one year of augmentation, breasts became very firm and lost over 25% of their volume. This was due to capsular contracture, a process that would lead to the collapse of the sponge and would continue to plague plastic surgeons and their patients for the next 50 years. In 1963, Cronin and Gerow introduced the silicone gel ‘natural feel’ implant, which revolutionized breast augmentation surgery. Approximately 10 companies have manufactured many types of silicone gel breast implants over the years. They obtained their raw materials for gels and shells from a similar number of other companies that entered and left the market at intervals. Many of the suppliers and manufactures changed their names and ownership over the years, and most of the companies no longer exist. No formal process of United States Food and Drug Administration premarket testing was in effect until 1988. There have been three generations of gel implants and a number of other lesser variations. First-generation implants (1963 to 1972) had a thick gel and a thick wall. They have generally remained intact over the years. Second-generation implants (1973 to the mid-1980s) had a thin gel and a thin wall. They have tended to disrupt over time. Third-generation implants (mid-1980s to 1992) had a thick wall and a thick gel. Except for those made by Surgitek, these implants remain intact. The breast implant business was competitive and companies introduced changes such as softer gels; barrier low-bleed shells; greater or lesser shell thickness; surface texturing; different sizes, contours and shapes; and multiple lumens in search of better aesthetics. Ultimately, more than 240 styles and 8300 models of silicone gel breast implants were manufactured in the United States alone. Inflatable breast implants were introduced in Toulons, France in 1965 (the Simaplast implant). There have been three main eras of inflatable implants: seamed, high-temperature vulcanized and room temperature vulcanized implants. In 1973, spontaneous deflation rates of 76% to 88% over three years were reported for many types of inflatable implants. Because of this, most plastic surgeons abandoned their use. From 1963 until the moratorium on gel implants (January 6, 1992), about 95% of all breast implants inserted were silicone gel filled. Only 5% were saline filled. Since the moratorium, this ratio has been reversed and 95% of all implants have been saline-filled, with only 5% being gel filled. Polyurethane-coated (PU) silicone gel implants were introduced in 1968. Over the next 20 years, they were shown to reduce the prevalence of capsular contracture to 2% to 3%. Other forms of surface texturing (Biocell, Siltex, multistructured implant) also appear to reduce capsular contracture with gel implants, but the reduction has been much less dramatic than that seen with PU implants. Contoured (anatomical) shaping appears to have advantages in some patients with gel implants. No such advantage has been seen for texturing or shaping with saline-filled implants. The story of gel implants has culminated in the largest class action lawsuit in medical history, with US$4.2 billion being awarded to women with silicone gel implants. During the past decade, there has been a tremendous amount of research on the reaction of a woman's body to gel implants. A plethora of studies have demonstrated that silicone gel implants are not associated with the development of any medical diseases. Silicone gel-filled implants have therefore been approved for use under Health Canada's Special Access Program. Silicone gel-filled implants may now be used in certain patients in whom they would provide advantages over saline implants. Silicone gel implants have not been approved for unrestricted general use. The evolution of breast implants occupies the past half century. It has been a stormy course, with many exciting advances and many bitter disappointments. The universe of breast implants is large and the variation among the implants is substantial. The purpose of the present review is to trace the evolution of breast implants over the past 50 years.

Dégonflement des prothèses mammaires pré-remplies de sérum physiologique ou d’hydrogel. Résultats et analyse d’une série de 650 patientes opérées

Subject : The main mechanical side effect of saline or hydrogel filled implants is deflation. The aim of this study was to analyse the prosthetic deflation rate in the last 7 years in the plastic surgery unit of Toulouse. Patients and methods : We tracked 650 patients operated on between july 1993 and july 2000 (representing 1117 primary implants) which we separated in two groups: the first group contained patients in need of breast reconstruction; the second group contained all the patients with implants placed for aesthetic or breast asymetry reasons. For each of the two groups we determined the number and the type of implants, as well as the rate and the mean delay after which deflation occurred. Results : During this period, we’ve determined that : • rate of deflation of group 1 (reconstruction) is highest than group 2 (aesthetic), despite sort of implant ; • rates of deflation of pre-filled hydrogel implants are highest than rates of deflation of pre-filled saline implants. Discussion : Only a few series concerning implants deflation have been described in the litterature. We can find a large difference in results which vary from 2 to 76%. We were surprised by the result of our series with a rate of deflation up to 15% with a medium follow-up 5 years in both groups and a mean delay before the fourth year. Deflation’s factors are numerous: type of sterilisation, rippling, texture, valve’s incompetence, prosthetic patch, guarantee controle and iatrogenic causes. Because the silicone gel implants (the one uncomplicated by deflation) were taken off the french market, the saline implants tried to supplant them but without satisfactory results. Conclusions : With the unacceptable rate deflation of implants in our study, the return in the french market of silicone gel implants seems us an acceptable alternative.

An association of silicone-gel breast implant rupture and fibromyalgia.

Silicone-gel breast implant rupture is common. Silicone-gel from ruptured implants may escape the scar capsule that forms around breast implants and become "extracapsular silicone." Our previously published study found that women with extracapsular silicone gel were at higher risk of reporting that they were diagnosed with fibromyalgia. There has been a limited number of studies addressing this association in the literature. Some studies addressing the issue of silicone breast implants and connective tissue disease specifically exclude patients with fibromyalgia from the sample or do not include the syndrome in the analysis. Case series describing fibromyalgia in patients with implants have been published, but many of these papers lack information on extracapsular silicone and are not representative because the patients are typically from referral populations. In addition, most studies do not have control groups of women without implants for comparison or do not distinguish between saline and silicone implants. Additional observational studies of women from nonreferral populations are necessary to validate an association. These studies should provide information on how the rupture is diagnosed, state whether the rupture extended beyond the capsule, and provide an appropriate control group for comparison. The findings from such studies may be important to physicians as they describe potential risks associated with implants to their patients. These findings should also be important for regulatory decision making on silicone-gel breast implants.

The Coincidence of TRAM Flaps and Prostheses in the Setting of Breast Reconstruction

It is well known that transverse rectus abdominis myocutaneous (TRAM) flaps can be used to replace unsatisfactory prosthetic breast reconstructions; however, little has been written about the scope of breast implant use in TRAM flap patients. In this study, to ascertain the range of such therapeutic options, their frequency, and their clinical outcomes, the authors retrospectively reviewed the senior author's breast reconstruction experience from 1989 to 2000 with patients in whom both a TRAM flap and an implant were used for breast reconstruction. The authors examined the surgical indications, body habitus, bra size, chest wall irradiation history, flap type, implant type, complications, and outcomes for those patients with TRAM flap and breast implant combinations.Thirty-two women who had 50 (various) combinations of a TRAM flap and a breast implant were identified. There were more clinical scenarios than patients because many of the women had multiple scenarios. The 50 combination scenarios were then divided into six groups. Group I consisted of 14 patients who had elective prostheses placed beneath simultaneous TRAM flaps; group II consisted of 10 patients who had TRAM flaps with contralateral prosthetic reconstruction (in which two implants were received before the TRAM flaps, five implants were received simultaneously with the TRAM flaps, and three implants were received after the TRAM flaps); group III consisted of eight patients who had contralateral augmentation in addition to their TRAM flaps; group IV consisted of 11 patients who had TRAM flaps that were used to cover or replace previous prosthetic reconstructions; group V consisted of four patients in whom prostheses were used to augment or improve previous TRAM flap reconstructions; and group VI consisted of three patients who required prostheses to either reconstruct or salvage total or near-total TRAM flap failures. A broad range of implant types was used, although anatomic saline implants predominated. Forty-one percent of the patients in the review had undergone irradiation during the course of their treatment for breast cancer. Eight of the 32 patients experienced a total of twelve complications, four of which were related to the implants and eight of which involved the TRAM flaps and abdominal donor sites.Although complex, the wide variety of potential TRAM flap/breast implant combinations can be useful for patients with challenging reconstructive scenarios, particularly those that involve radiation therapy. In the group of patients reviewed by the authors, TRAM flaps were most often used in successful partnership either on the same side as or opposite to an implant reconstruction. A TRAM flap was used to salvage or replace an unsatisfactory implant reconstruction in less than a third of the patients. From a risk point of view, implants used opposite a TRAM flap reconstruction had a lower incidence of complication than did implants used beneath TRAM flaps.

Importance of the periareolar approach in the augmentation of the ptotic breast.

This is a retrospective review of 66 patients with grade II breast ptosis who underwent augmentation mammaplasty from January 1996 to January 2001. Of these 66 patients, 17 were augmented using a periareolar approach, and 49 were augmented using an inframammary approach. All patients had textured saline implants, and 64 of 66 patients had the implants placed in a submuscular position. Mean photographic follow-up was 4.8 months (range, 6 weeks-1 year). When compared with an inframammary approach in the presence of grade II ptosis, a periareolar approach results in improved fill of the lower pole of the breast, improved centralization of the nipple on the breast mound, and lessening or elimination of undesirable upper pole fullness.

Observations on a consecutive series of patients who have had Trilucent breast implants removed as recommended by the MDA Hazard Notice (May 2000)

A prospective study of 25 female cosmetic-surgery patients who had a total of 50 Trilucent breast implants forms the basis of this paper. All but one patient elected to have new implants, of which all but three patients had silicone implants (the others selected glucose saline implants). The Trilucent implants were more difficult to remove than expected because of a 'Velcro-like' attachment to the internal surface of their capsules. As a result, several implants were ruptured on removal (though none were ruptured on initial exposure). The sites of rupture suggest a structural weakness, possibly related to the microchip panel or folds in the implant shell. Varying degrees of encrustation of the implants and internal capsules were found, which did not appear to be related to the duration of implantation. Histological studies of the capsule changes generally showed lipids and giant cell infiltrations. It would seem that, contrary to expectations, leaking of the filler occurs early and is associated with varying degrees of cellular reactions. The adherence problem appears to be related to the amount and distribution of the leaked material. Only three patients in this series had problems with their Trilucent implants that required additional surgery. One of these remains a significant and unsolved problem.

Future Directions in Breast Implant Surgery

Breast implant surgery will remain a major component of the practice of plastic surgery. The future may hold promise for the introduction of new implants for the augmentation of the breast and for reconstruction. The constant demand and pressure placed on the manufacturers to keep developing new fillers are proof that satisfaction with saline implants is lacking. Today, however, the saline implant may be believed to be the safest breast implant available for clinical application. The demand necessitates that implants be used for enhancement of a woman's self image and for reconstruction. The smooth-surface implants are considered more popular and safer for patients, perhaps because it has been well documented that the shell may have been the cause of the problem. However, the constancy in holding on using and reapplying the same principles of a faulty shell may not be as scientific an endeavor as we have done in the past, and to keep placing different fillers in the faulty shell. Perhaps the lamination process used in manufacturing, the air in the shell, or wear and tear produces mechanical weakening of the shell that eventually will lead to loss of integrity of the silicone-shell breast implant. The global community is looking to plastic surgeons for a solution. The applications and the demand for breast implants are global in nature. Meanwhile, as clinicians are waiting for a new implantable breast device, they will continue to use what is available and advise patients that the implantation of a breast prosthesis is not a life-long endeavor. There is a need, however, for the implants to be maintained by the process of exchange every 8 to 10 years. Breast reaugmentation is to be performed as a standard because plastic surgeons will be waiting for further clarifications from the regulators or the scientific community. The goal is to produce a good outcome and maintain safety for the patients with a high standard of care.

Breast Augmentation with Full-Height Anatomic Saline Implants: The Pros and Cons

Full-height anatomic implants, like round implants, have advantages and disadvantages. Based on 21 years' experience using round implants and 10 years' experience using anatomic implants, the author believes that anatomically shaped implants offer substantial, significant advantages compared with round implants in more than 90% of primary augmentations. Anatomic implants are a significant addition to the armamentarium of any surgeon who performs primary breast augmentation, provided that the surgeon is willing to meet requirements for optimal use of these more sophisticated products: more stringent implant selection based on individual patient tissue characteristics, accurate pocket dissection under direct visualization, accurate implant positioning based on measured and visual parameters, and above all, detailed patient informed consent about the trade-offs of all implant options. Absent the willingness and skills development to meet these requirements, surgeons should avoid using anatomic implants.

The fate of the fibrous capsule after saline implant removal.

After removal of a silicone breast implant, if a capsulectomy is not performed, the residual capsule may persist, become calcified, and appear on routine mammograms. The fate of the capsule around saline implants is less clear. The purpose of this study was to determine the fate of the capsule around saline-filled implants in an animal model. Rats were implanted with 6-ml tissue expanders, which were left in place for 4 months. The implants were then removed and the capsules around the injection port (smooth surface) and tissue expander (textured surface) were examined sequentially. The capsules contracted and dissipated gradually over a year in association with a pericapsular vascular proliferation. It may not be necessary to perform a capsulectomy at the time of saline implant removal.

Breast Cancer after Augmentation Mammaplasty: Treatment by Skin-Sparing Mastectomy and Immediate Reconstruction

Breast conservation has been associated with poor cosmetic outcome when used to treat breast cancer in patients who have undergone prior augmentation mammaplasty. Radiation therapy of the augmented breast can increase breast fibrosis and capsular contraction. Skin-sparing mastectomy and immediate reconstruction are examined as an alternative treatment.Six patients with prior breast augmentation were treated for breast cancer by skin-sparing mastectomy and immediate reconstruction. One patient underwent a contralateral prophylactic skin-sparing mastectomy. Silicone gel implants had been placed in the submuscular location in five patients and in the subglandular position in one patient a mean of 10.2 years (range, 6 to 20 years) before breast cancer diagnosis. The mean patient age was 41.3 years (range, 33 to 56 years). Four independent judges reviewed postoperative photographs to grade the aesthetic results in comparison with the opposite native or reconstructed breast. The American Joint Committee on Cancer staging was stage 0 in one patient, stage I for four patients, and stage II for one patient. Five of the six patients presented with a palpable breast mass. Latissimus dorsi flap reconstruction was performed in four patients (bilaterally in one) and a transverse rectus abdominis muscle (TRAM) flap was used in two patients. Three patients were treated by skin-sparing mastectomy with preservation of the breast implant (two patients with latissimus flaps, and one patient with a TRAM flap). The tumor location necessitated the removal of implants in two patients (one patient with a latissimus flap and one with a TRAM. A saline implant was placed under the latissimus flap after gel implant removal. The patient who underwent bilateral skin-sparing mastectomies desired explantation and placement of saline implants. No remedial surgery was performed on the opposite breast to achieve symmetry. Complications occurred in two patients at the latissimus dorsi donor site (seroma in one patient, and seroma and infection in one). Five patients underwent complete nipple reconstructions. The mean duration of follow-up was 33.6 months (range, 15.5 to 70.3 months), and there were no recurrences of breast cancer. The aesthetic results were judged to be good to excellent in all cases.Skin-sparing mastectomy and immediate reconstruction can be used in patients with prior breast augmentation, with good to excellent cosmetic results. Depending on the tumor and implant location, the implant may be preserved without compromising local control.

Calcification properties of saline-filled breast implants.

Three patients requested explantation of their saline-filled breast implants. Bilateral calcification had occurred in all six implants. Four of the implants were manufactured by McGhan Corporation (Santa Barbara, Calif.), and two, by the Simaplast Company (Toulon, France). All implants had been inserted in the subglandular plane and had been in place for 7 to 23 years. At the time of explantation, patients were 32, 34, and 44 years old. Calcification on the surface of the implants and capsules was analyzed. Implant surface calcification was clinically evident on all six implants, appearing as ivory-colored, tenaciously adherent deposits, only on the anterior surface of the implant. Capsular calcification, which was observed only microscopically, was characterized by poorly organized, irregularly shaped, calcified agglomerates; this calcification also occurred only on the anterior surface of the capsule, adjacent to the area of calcification on the implant. Ultrastructural analysis of scrapings from the implant surface showed large, electron-dense aggregates of crystals, with individual crystals measuring approximately 40 x 10 x 10 nm. In contrast, capsular calcification was characterized by two patterns of deposition, spherulitic aggregates of needle-shaped crystals and areas of metaplastic bone. The individual crystals were approximately 40 x 10 x 10 nm. Energy-dispersive x-ray spectroscopy of specimens from the areas of calcification on the implant and capsule surfaces demonstrated calcium and phosphorus. Electron diffraction of crystals from the implant and capsule surfaces demonstrated the D-spacings characteristic of calcium apatite. There were many differences between the calcification properties of these six saline implants and those of silicone gel implants. For example, mineralization has not been observed on the surface of gel implants, but in these saline implants it occurred primarily on the implant surface. Also, capsular calcification has been observed clinically in gel implants across the surface of the capsule (except at the site of attachment of a Dacron patch), but in this study it was observed only microscopically and was located on the anterior surface of the capsule, adjacent to the area of calcification on the implant. In addition, crystals 100 times larger than those observed on the six saline implant capsules have been observed on the surface of gel implant capsules. A model is presented to explain the mechanism of calcification associated with breast implants and to explain the observed differences between saline-filled and gel-filled implants.