What exactly was wrong with the Trilucent breast implants? A unifying hypothesis

Trilucent soybean oil-filled breast implants were initially announced as the ultimate prostheses for breast augmentation. However, after an increasing number of reports of local complications and hazardous metabolites attributable to lipid oxidation, first the United Kingdom Medical Devices Agency and later the Belgian National Ministry of Health urged all plastic surgeons to contact their patients and advise them to have the implants removed and, if desired, replaced with another type of prosthesis. In our plastic surgery department, 13 patients received bilateral implants with triglyceride-filled prostheses between February and July of 1996, for primary breast augmentation or replacement of previously implanted prostheses. For 12 of those 13 patients, the prostheses have been explanted, because of unilateral breast enlargement attributable to a ruptured prosthesis for five patients and following the recommendation of the Belgian National Ministry of Health for the other seven patients. Before explantation, all patients underwent standard clinical examinations, with assessments of breast shape, volume, and firmness. Blood analyses were performed, with a special focus on liver enzymes, as were urinalyses. Magnetic resonance imaging scans were obtained before explantation; for two patients, the scans revealed a fluid level separating two liquid layers in an intact prosthesis. This is the first report of such a finding. The removed implants were examined for any damage or shell deterioration and for changes in color and viscosity, the weights and volumes were measured and compared with the initial values for the implanted prostheses, and complete biochemical analyses of the accumulated fluid in cases of ruptured prostheses and of the filler material in cases of intact prostheses were performed. This small but well-documented series illustrates the multitude of problems associated with triglyceride-filled implants, including bleeding of the triglyceride filler; shell deterioration, as indicated by a loss of texture and extreme fragility of the implant (with rupture or delamination with a simple finger touch); an increase in osmotic pressure exerted by the degraded filler material; progressive weakening of the outer silicone shell, with influx of plasma proteins of up to 750 kDa, eventually resulting in rupture of the prosthesis; a lack of oxidative stability and the formation of toxic oxidation products; a lack of biocompatibility, with the formation of insoluble organic soap-like material; and a pronounced inflammatory reaction. It is concluded that the sequential and/or simultaneous occurrence of (1) implant bleeding, (2) lipid infiltration of the silicone elastomer, and (3) inflammation attributable to oxidation products provides an overall explanation or unifying hypothesis for the wide variety of adverse events related to soybean oil-filled implants.     

Why change a good thing? Revisiting the fleur-de-lis reconstruction of the breast

Although the latissimus flap is known for its simplicity and reliability, use of the fleur-de-lis pattern was plagued by undesirable T-shaped donor sites and small breast volumes in thin patients. We report a modified technique for optimal shaping of the standard latissimus with the successful application of a modified fleur-de-lis pattern. Because a "wet" tumescent infiltration was utilized and large amounts of subcutaneous fat were harvested, these changes permitted application to a wide variety of patients, with generous breast volumes reducing the size of the implant placed and resulting in excellent donor-site scars.This is a retrospective cohort study of 53 delayed or immediate reconstructions performed consecutively by the principal author (M.E.A.) on 48 patients at a university-based, urban hospital. Each case was analyzed between April of 1995 and February of 1999, with a follow-up from 2.5 to 44 months. All patients underwent injection of tumescent solution into the subcutaneous plane and harvest of large amounts of subcutaneous fat with the neurologically intact latissimus muscle. The last 25 reconstructions utilized the modified fleur-de-lis skin pattern, an inferiorly based vertical limb and replacement of skin deficiency in both axes.Of 11 perioperatively irradiated patients, none required skin grafting, whereas 6 percent of all native mastectomy flaps were grafted. There was one instance of minor distal tip flap necrosis in a nonirradiated patient. No implants became infected or were extruded. Donor sites were without wound complications and unveiled a 16 percent overall seroma rate.Through selective addition of harvested tissue, this modified technique, particularly the fleur-de-lis pattern, permits improved volume and projection in the inferior pole. The T-shaped donor-site closure is not only acceptable, but is also desirable, with reduced wound tension and minimization of dog-ear formation. With a relative paucity of complications, this conceptually ideal modification is technically simple and aesthetically comparable to our transverse rectus abdominis muscle flap results.     

Symmetrical breast reconstruction: is there a role for three-dimensional digital photography?

Clinical applications of three-dimensional digital photography include assessments of breast volume and contour. It was hypothesized that knowledge of preoperative and postoperative breast volumes might facilitate obtaining symmetry after reconstructions with autologous tissue or implants. Breast reconstruction was performed for 382 women during a 4-year period. Of those women, 334 completed all phases of the reconstruction and underwent symmetry analysis. Reconstructive procedures included the use of pedicle transverse rectus abdominis musculocutaneous flaps, free transverse rectus abdominis musculocutaneous flaps, deep inferior epigastric perforator flaps, superior gluteal artery perforator flaps, or latissimus dorsi flaps or expanders/implants. Three-dimensional digital photographic images were obtained for 33 women, whereas the remaining 301 women were not digitally photographed. The differences in symmetry after the initial reconstruction and after the secondary procedures were compared for all women and for the groups with and without three-dimensional photographic images. For the group with three-dimensional imaging, initial volume symmetry was obtained for 73 percent, initial contour symmetry was obtained for 27 percent, secondary procedures were necessary for 70 percent, final volume symmetry was obtained for 88 percent, and final contour symmetry was obtained for 79 percent. For the group without three-dimensional photographic images, initial volume symmetry was obtained for 57 percent, initial contour symmetry was obtained for 34 percent, secondary procedures were necessary for 50 percent, final volume symmetry was obtained for 80 percent, and final contour symmetry was obtained for 71 percent. The results demonstrated that there was no significant difference in final contour and volume symmetry between women who had or did not have three-dimensional digital photographic images taken. However, the results demonstrated that autologous tissue reconstructions resulted in improved contour and volume symmetry, compared with implant reconstructions.     

Microtia reconstruction: does the cartilage framework grow?

The use of free rib cartilage ear frameworks in unilateral microtia reconstruction has prompted much discussion about their potential for growth. The senior author has reconstructed ear frameworks in 132 microtia patients, most of whom were under 3 years of age when surgery was initiated. Of this group, 29 were assessed for ear growth through comparison of the lead-plate model of the original normal ear to the normal ear growth and the reconstructed ear framework after a period of at least 2 years. Similarly, 14 reconstructed ears were compared to 14 normal ears at least 2 years after reconstruction. The perimeters of tracings made from the original lead plates and of tracings of normal and reconstructed ears were determined by image analysis techniques. The results demonstrated no significant difference in growth between normal ears and reconstructed ear frameworks after an interval of at least 2.5 years. Therefore, the reconstructed ear is growing at a rate similar to that of the normal ear.     

TRAM flap versus nonautologous breast reconstruction: what do patients really think?

Although there have been many reports of aesthetic outcomes after breast reconstruction, there have been comparatively few studies examining patient satisfaction and related subjective issues. The variables affecting satisfaction are only beginning to be understood, and patient satisfaction issues were explored in a more homogeneous patient population. A questionnaire surveying overall and aesthetic satisfaction, postoperative recuperation time, and symptoms was used to elicit candid patient responses. Fifty-seven patients replied (86 percent response rate), of whom 38 had undergone transverse rectus abdominis musculocutaneous (TRAM) flap (pedicled, n = 29; free, n = 9) reconstruction and 19 had undergone nonautologous reconstruction. Although the median patient satisfaction score was higher for the TRAM flap group, this was not statistically significant (p = 0.92). Recuperation was significantly longer for the TRAM flap group, with only 47 percent of patients being able to resume full activities within 2 months after the surgical procedure, compared with 95 percent of the implant group (p = 0.002). Of the TRAM flap-treated patients, 50 percent described some postoperative abdominal weakness, but only 5 percent of all TRAM flap-treated patients said that abdominal weakness was actually a functional problem. Our results suggest that patients may derive equal satisfaction with the two methods of reconstruction. The postoperative recuperation time after TRAM flap reconstruction is significantly longer than that after nonautologous procedures, although the postoperative abdominal weakness after TRAM flap reconstruction is not as significant a clinical problem as previously thought. The patient-derived information on satisfaction should assist both surgeons and patients in matching reconstructive options with patients' expectations and lifestyle.