Silicone breast implant litigation (Part 1)

Silicone breast implant litigation has escalated in the past couple of years with the Food and Drug Administration (FDA) investigation of silicone gel implants which resulted in finally removing the silicone gel implants from the market. Plaintiffs have linked various medical problems to the presence of silicone in the body. The FDA has stated that there is no medical evidence that silicone causes autoimmune disease. Silicone has never been shown to cause breast cancer. Breast implants can result in complications such as capsule contracture, gel bleed, implant rupture, calcifications around the implants, and possibly interference with mammography in the diagnosis of breast cancer. Plaintiffs have claimed that the implant manufacturers knew of the defects in the silicone shell implant covering, and covered up the facts. The product liability action has become a class action, and a proposed settlement has been made in terms of which implant recipients with any problems will be reimbursed. Furthermore, there will be coverage for future implant problems over the next 30 years. There will still be some litigation by those patients who have opted out of the settlement agreement.     

Silicon analysis of breast and capsular tissue from patients with saline or silicone gel breast implants: II. Correlation with connective-tissue disease

The silicone breast implant controversy rages on. Recent work has demonstrated that normal or baseline breast tissue silicon levels in women who had had no prior exposure to any type of breast implant may be as high as 446 microg/gm of tissue. These data ranged from 4 to 446 microg/gm of tissue, with a median of 27.0 microg/gm of tissue. In addition, numerous other epidemiologic and rheumatologic studies have demonstrated no association between silicone breast implants and any connective-tissue diseases. Despite these reports, the use of silicone implants remains restricted. The present study measured breast and capsular tissue silicon levels from 23 breasts in 14 patients with saline implants, and from 42 breasts in 29 patients with silicone implants. No patient in the saline implant group presented with signs or symptoms of connective-tissue disease. Patients with silicone implants, however, were divided into three groups based on the presence or absence of signs or symptoms of connective-tissue disease: group I, no symptoms or signs; group II, + symptoms, no signs; and group III, + symptoms, + signs. Six patients in group III were diagnosed with a specific connective-tissue disease, including systemic lupus erythematosus, rheumatoid arthritis, or scleroderma. The most common indications for implant removal or exchange were capsular contracture and implant rupture, although 41 percent of patients with silicone implants expressed media-related concern over the implant issue. The most common symptoms described by patients in groups II and III were joint pain and stiffness, arm pain and numbness, and fatigue. In all groups, capsular tissue silicon levels were significantly greater than breast tissue levels. This finding may indicate that the capsule serves as a barrier to the distribution of silicone from the implant into adjacent breast tissue. Although breast tissue silicon levels in patients with silicone implants were not significantly greater than those in patients with saline implants (p = 0.48), capsular tissue levels in patients with silicone implants were, indeed, significantly greater than those in patients with saline implants (p < 0.001). However, no statistically significant differences in tissue silicon levels were observed with relation to the presence or absence of connective-tissue disease signs or symptoms in patients with silicone implants (groups I to III). Therefore, these data strengthen the conclusion that there is no association between tissue silicon levels and connective-tissue disease.     

Reconstruction of residual alveolar cleft defects with one-stage mandibular bone grafts and osseointegrated implants

PURPOSE: This study evaluates a treatment regimen for reconstruction of residual maxillary alveolar cleft defects consisting of mandibular bone grafting and immediate implant installation. PATIENTS AND METHODS: Sixteen cleft patients (five female and 11 male) had residual cleft defects of the alveolar ridge reconstructed with bone grafts from the mandibular symphyseal region. The bone graft was pretapped at the donor site before fixation in the residual ridge with Br?nemark implants. Twenty implants were installed according to this concept. The period of observation ranged from 36 to 69 months, with a mean of 48 months after implant installation. RESULTS: Five patients developed wound dehiscenses that resulted in total or partial bone graft sequestration. Two implants were lost, one due to sequestration and the other due to mobility at the abutment procedure; 18 implants were still well functioning at the end of the observation period. However, all patients showed significant periimplant bone resorption after this one-stage treatment. CONCLUSION: Because of the observed complication rate, the one-stage procedure may not be optimal for reconstructing residual cleft defects.     

Reconstruction of alveolar defects before implant placement

Guided bone regeneration and bone grafting have been used to reconstruct defective alveolar ridges in preparation for implant placement. This phase of implant treatment is critical to a successful overall result. Remarkable advances that have occurred in techniques and materials enable us to place and restore implants in cases where previously it was not feasible. Three case reports are presented to illustrate successful management of different alveolar defects.     

Mandibular onlay grafting using prefabricated bone grafts with primary implant placement: an experimental study in minipigs

The aim of this experimental study was to evaluate the use of prefabricated autogenous bone grafts as onlay grafts to the mandible. Excess bone of 10 x 12 x 40 mm was produced inside blocks of pyrolyzed bovine bone under a polylactic membrane coverage on the outside of the mandible in 15 adult G?ttingen minipigs. After 5 months, this bone was harvested and transferred to the premolar region of the mandibular body in 10 animals. Onlay grafts of mandibular bone were used as controls for the transplanted prefabricated grafts. All grafts were fixed by primary placement of one titanium implant each. Five animals served as ungrafted controls. Evaluation was performed after 3 months and 5 months, respectively. Two animals were lost to evaluation, and one scaffold became infected. Eleven of the remaining 12 scaffolds showed sufficient bone ingrowth for grafting. Three months after transplantation, bone volume of the prefabricated grafts was almost completely preserved, with only minimal resorption in the superficial pores of the scaffolds, while the control grafts exhibited partial resorption. The titanium implants, which had been placed at the time of only grafting, exhibited direct bone-implant contact. Five months after grafting, all titanium implants showed complete osseointegration, with direct bone-implant contact. The grafted bone exhibited a significant increase in bone density by appositional bone formation. The control grafts were nearly completely resorbed at that time.     

Implant reconstruction of the jaws and craniofacial skeleton

Full oral rehabilitation with a high degree of success is now possible with osseointegrated implants. Osseointegration is a direct connection between living bone and the titanium implant at the level of the light microscope. Osseointegrated implants are currently used to replace single teeth, support fixed bridges and stabilize full dentures. These implants can also be placed extraorally for attachment of facial prosthesis. The surgical technique used to place implants intraorally into jaws or facial skeleton is performed in two stages using a local anesthetic and/or conscious sedation. During stage I surgery, holes are placed into the jaw using a series of gradually larger diameter burs until the desired diameter and depth of the bony preparation is achieved. The implant is then placed. The implant must remain undisturbed for 4 months for osseointegration to take place. Stage II surgery is then required to remove the mucosa over the implant and place the transmucosal abutment. After 1-2 weeks of healing, the restorative dentist can take an impression and fabricate the prosthesis. On occasion, it is necessary to augment the height and width of the atrophic jaw with autogenous or allogeneic bone grafts prior to implant placement. Bone grafts are sometimes placed on the floor of the nose or the floor of the maxillary sinus. Guided tissue regeneration is a technique used to generate bone within bony defects adjacent to implants. With long-term rates of success (5 years) of 99% for implants placed in the mandible and 95% for those placed in the maxilla, reconstruction of the jaws and cranial facial skeleton with osseointegrated implants has become the treatment of choice.     

Effects of guided bone regeneration around commercially pure titanium and hydroxyapatite-coated dental implants. II. Histologic analysis

The purpose of this study was to determine which treatment of a large osseous defect adjacent to an endosseous dental implant would produce the greatest regeneration of bone and degree of osseointegration: barrier membrane therapy plus demineralized freeze-dried bone allograft (DFDBA), membrane therapy alone, or no treatment. The current study histologically assessed changes in bone within the healed peri-implant osseous defect. In a split-mouth design, 6 implants were placed in edentulous mandibular ridges of 10 mongrel dogs after preparation of 6 cylindrical mid-crestal defects, 5 mm in depth, and 9.525 mm in diameter. An implant site was then prepared in the center of each defect to a depth of 5 mm beyond the apical extent of the defect. One mandibular quadrant received three commercially pure titanium (Ti) screw implants (3.75 x 10 mm), while the contralateral side received three hydroxyapatite (HA) coated root-form implants (3.3 x 10 mm). Consequently, the coronal 5 mm of each implant was surrounded by a circumferential defect approximately 3 mm wide and 5 mm deep. The three dental implants in each quadrant received either DFDBA (canine source) and an expanded polytetrafluoroethylene membrane (ePTFE), ePTFE membrane alone, or no treatment which served as the control. Clinically, the greatest increase in ridge height and width was seen with DFDBA/ePTFE. Histologically, statistically significant differences in defect osseointegration were seen between treatment groups (P < 0.0001: DFDBA/ePTFE > ePTFE alone > control). HA-coated implants had significantly greater osseointegration within the defect than Ti implants (P < 0.0001). Average trabeculation of newly formed bone in the defect after healing was significantly greater for HA-coated implants than for titanium (P < 0.0001), while the effect on trabeculation between treatments was not significantly different (P = 0.14). Finally, there were significantly less residual allograft particles in defect areas adjacent to HA-coated implants than Ti implants (P = 0.0355). The use of HA-coated implants in large size defects with DFDBA and ePTFE membranes produced significantly more osseointegration histologically than other treatment options and more than Ti implants with the same treatment combinations. The results of this study indicate that, although the implants appeared osseointegrated clinically after 4 months of healing, histologic data suggest that selection of both the implant type and the treatment modality is important in obtaining optimum osseointegration in large size defects.     

Endosseous implant and autogenous bone graft reconstruction of mandibular discontinuity: a 12-year longitudinal study of 31 patients

Surgical, medical, and prosthodontic records of 61 consecutively treated patients with mandibular discontinuity were reviewed retrospectively. All 61 patients had undergone discontinuity reconstruction with autogenous bone grafts; 31 of 61 had also received endosseous dental implants and a dental osseoprosthesis. Of these 31 implant-reconstructed patients, 23 had free autogenous nonvascularized and 8 had vascularized bone grafts. The surgical-prosthetic protocol consisted primarily of secondary, free autogenous nonvascularized bone graft reconstruction and secondary root-form endosseous implant and fixed prosthesis dental reconstruction. Vascularized bone (8 patients) or soft tissue (4 patients) grafts were utilized selectively for severely compromised patients after extensive oncologic resection, avulsive trauma, or after previous radiation treatment. Endosseous implant survival (95.5% in 31 patients), autogenous bone graft success (98.4% in 61 patients), and dental osseoprosthesis success (100% in 31 patients) were favorable. A high incidence (9.1%) of nonfunctioning (sleeping) implants was recorded for this patient population. The need to remove the titanium mesh tray for various reasons (17.6%) and the need to reconstruct soft tissue in the irradiated patient (12%) were noteworthy.     

High implant fracture incidence with Sutter silicone metacarpophalangeal joint arthroplasty

We performed a retrospective review of Sutter silicone metacarpophalangeal (MP) joint arthroplasties in 34 patients (42 hands, 168 implants) with rheumatoid arthritis. Patients were evaluated at an average of 27 months (minimum follow-up period, 12 months). Twenty percent of the implants were shown to be definitely fractured on final follow-up examination, and 45% followed for more than 3 years were definitely fractured. At the final follow-up examination, the average ulnar drift in intact implants was 11 degrees and in the fractured implants, 23 degrees. However, there was no correlation between implant fracture and patient satisfaction. Eighty percent of patients said they would undergo the procedure again. Because of a significantly higher implant fracture incidence at a relatively shorter follow-up period than that of most studies of silicone MP implants of the Swanson design, we have abandoned the use of the Sutter implant.     

Altered patterns of DNA methylation on chromosomes from leukemia cell lines: identification of 5-methylcytosines by indirect immunodetection

The feasibility of implant treatment in patients after oral ablative tumor surgery has not yet been investigated with consideration of the requisite high periodontal standards. A report on this topic has to deal not only with implant survival but also with implant health, bone response, soft tissue health, failure pattern, time of failure, and ease of restoration. For the assessment of an implant system, an overview must be accomplished that takes into account the different restorations used and their interaction with the implant system that was used. This study presents the Bone-Lock implant system (Howmedica Leibinger GmbH, Freiburg, Germany) in a retrospective investigation after 5 years of follow-up with special emphasis on the prosthetic restorations used following resection of oral malignancies. From early in 1990 through June 1996, we inserted 210 dental endosteal Bone-Lock implants (58 patients) after oral tumor resectioning. Included in the study were 45 patients with 162 implants and prosthetic restorations that had been loaded for 1 year (dentures retained by telescopic or bar-clip or ball attachments, implant-supported prostheses, tooth-to-implant connected bridges). Regular follow-up consisted of evaluation of the Plaque Index (Silness and L?e) and of the Sulcus Bleeding Index (L?e), measurements of pocket probing depth, implant mobility (by means of the Periotest method), bone resorption (according to X-ray findings), and a questionnaire that registered patient satisfaction. The results were evaluated for each restoration and were compared with baseline standards. The overall 5-year survival rate was 83.2%. For implants that had been in place for over 365 days, the survival rate was 93%. The investigation showed that after resection of oral malignancies, patients could be treated with dental implants and superstructures with long-term efficacy similar to that found in healthy subjects considering internationally accepted standards. Implant treatment in tumor patients appeared to offer the most positive periodontic results when use of bar-clip or telescope-retained overdentures was involved. The patient satisfaction level with the described prosthodontic treatment was satisfactory.     

Ruptured or intact: what can linear echoes within silicone breast implants tell us?

OBJECTIVE: During sonographic evaluation of silicone breast implants for possible rupture, we have frequently encountered several patterns of linear echoes within the implants. To our knowledge, the significance of this finding has not been established in the literature. The purpose of this study was to determine whether internal echoes are significant in predicting implant rupture. SUBJECTS AND METHODS: Thirty-three patients with 64 silicone implants were prospectively entered into a study that included gray-scale sonography of the implants and subsequent surgical removal. Echo patterns within the implants were retrospectively evaluated on hard-copy films and compared with the integrity of the implant at surgery. RESULTS: Three categories of internal echo patterns were identified: "thick linear echoes." "thin linear echoes," and "commas." One or more of these echo patterns were seen in 57 (89%) of the 64 implants. Thick linear echoes were seen in 23 (36%) of the 64 implants, thin linear echoes were seen in 33 (52%) of the 64 implants, and commas were seen in 47 (73%) of the 64 implants. All echo patterns were seen in intact and ruptured implants with nearly equal frequency. We found no statistical significance for any echo pattern in predicting whether an implant was ruptured or intact. Of the 64 implants, four were entirely free of internal echoes. All four implants were intact. CONCLUSION: A variety of linear echoes can be seen in most silicone breast implants on gray-scale sonography. The presence or absence of linear echoes is not useful in predicting implant rupture. Complete absence of internal echoes, while highly predictive of an intact implant, is infrequently seen.     

Diagnosing breast implant rupture with MR imaging, US, and mammography

A total of 135 symptomatic women with 262 breast implants were examined with magnetic resonance (MR) imaging performed with a body coil, ultrasound (US), or both to determine imaging features of implant rupture. Surgical proof was available for 33 women with 62 implants; 24 were ruptured and 38 were intact. Complicated internal structure was the most reliable predictor of implant rupture: Diffuse low-level echoes were seen on sonograms in 56% of ruptured implants; internal membranes (which correspond to the collapsed implant shell) were seen on MR images in 58% of ruptured implants. Fluid droplets were seen within the silicone in 26% of ruptured implants on MR images. Irregular implant contour can be a sign of rupture but is unreliable. Fluid collections around silicone implants are not a sign of rupture. At present, neither US nor conventional MR imaging with a body coil is sufficiently reliable to advocate routine screening of asymptomatic women with breast implants. Evaluation with MR imaging performed with a surface coil is more reliable.     

Inhibition of eFGF expression in Xenopus embryos by antisense mRNA

This pilot study analyzed the bone reactions to early loaded titanium plasma-sprayed implants. A total of 24 titanium plasma-sprayed implants (12 in the maxilla and 12 in the mandible) (Primary Healing Implant, Legnano) were inserted into four Macaca fascicularis monkeys with instruments specially designed to obtain a precise fit of the implant in the bone socket. A metal superstructure was cemented into 10 mandibular and 10 maxillary implants 15 days after implant insertion. The four remaining implants were used as controls. Eight months after implant placement, a block section was carried out, the defect was filled with nonresorbable hydroxyapatite, and all 24 implants were retrieved. The implants were treated to obtain thin ground sections that were examined under normal and polarized light. Histologic analysis showed that bone was observed around the implant surface in all implants. Morphometric analysis demonstrated that bone lined 67.2% (SD = 3.1%) of the maxillary implant surface, and 80.71% (SD = 4.6%) of the mandibular implant surface. No differences were found in the percentage of bone-implant contact in the control implants. In the loaded implants, however, the bone around the implants had a more compact appearance. The study demonstrated that it is possible to obtain a high percentage of bone-implant contact in early loaded titanium plasma-sprayed implants.     

Cardiac tamponade as a clinical symptom of systemic lupus erythematosus

Upper lid closure in facial nerve paresis induced lagophthalmos is often improved by implantation of gold weights. However, the tolerability of gold implants has not always met expectations. We therefore investigated whether results could be improved by implantation of well-tolerated platinum implants. PATIENTS AND METHODS: Three patients with lagophthalmos received pretarsal platinum-iridium implants in the upper lid. The implants were primary in two patients and secondary in one. In this patient, the previous gold implant had led to marked swelling and redness of the upper lid 6 weeks after surgery. The platinum implants were prefabricated with a radius of 20 mm and weighed between 1.3 and 1.4 g. During implantation, they were individually contoured to fit lidcurvature and attached pretarsally with nonresorbable thread. RESULTS: Postoperatively, the upper lid of all three patients could be closed completely. The implants healed without irritation. No lid swelling occurred during 2-to 6-month follow-up. Because platinum-iridium alloys have a higher specific gravity (Ptlr 90/10 = 21.65 g/cm3) than gold (18.43 g/cm3), they can attain equal weight at smaller size. CONCLUSIONS: Our first results show that platinum implants are a feasible alternative to gold implants in treating lagophthalmos due to better biocompatibility and higher specific gravity.     

A historical review of mental health services in Hong Kong (1841 to 1995)

OBJECTIVE: To review the experience of 1 microvascular surgeon during an 11-year period in performing 210 vascularized bone-containing free flaps for oromandibular reconstruction. DESIGN: Retrospective medical records review of patients who underwent primary and secondary oromandibular reconstruction with the use of vascularized bone free flaps. SETTING: Academic medical center. PATIENTS: A total of 201 patients underwent 210 composite free-flap reconstructions of the mandible for various disorders and with a range of bony and soft tissue defects. INTERVENTION: All patients underwent the microvascular transfer of vascularized bone flaps from the ilium, fibula, or scapula. In selected cases, 2 simultaneous free flaps were transferred to achieve an optimal bone and soft tissue reconstruction. Endosteal dental implants were used in 81 patients, with a total of 360 fixtures placed during these 11 years. MAIN OUTCOME MEASURES: The success of microvascular free tissue transfer, dental implant extrusion, and short- and long-term complications at the recipient and donor sites. RESULTS: Of the 210 mandibular reconstructions that were performed, 202 were successful in reestablishing mandibular continuity. Reexploration for vascular-related complications was done in 16 patients, 8 of whom were successfully treated, yielding an overall success rate of 96%. The overall success rate for endosteal dental implants was 92%. The implant success rate was 86% when the bone in which the fixtures were placed was irradiated postoperatively. The success rate was 64% in the 14 fixtures that were placed into previously irradiated bone. CONCLUSIONS: The success of the use of vascularized bone free flaps in restoring continuity to the mandible is clearly demonstrated in this series. There was an acceptable incidence of donor- and recipient-site complications that resulted in minimal long-term morbidity. The careful selection of a donor site(s) for oromandibular reconstruction allows for an optimal restoration of bony and soft tissue defects. Dental implants can be safely used in oromandibular reconstruction with a high level of success. Placing these implants during the initial surgery shortens the duration for achieving dental rehabilitation and enhances the success of the implants when postoperative radiotherapy is administered.     

Distribution of organosilicon polymers in augmentation mammaplasties at autopsy

Silicone-containing breast implants have been used since 1963 for cosmetic augmentation and breast reconstruction. Currently, there is intense debate regarding the extent and mechanism of migration of silicone from the area of implant. The current study compares tissue distribution of organosilicon polymers between women with and without silicone breast implants to determine the extent of silicone migration from breast implants. Samples were collected at autopsy from 15 individuals with bilateral breast implants with no known history of chest trauma and from 14 age- and sex-matched controls. Capsule, breast, axillary lymph nodes, abdominal fat, liver, lung, and spleen were collected for analysis of organosilicon polymers by atomic absorption spectrometry and for examination by light microscopy. Blood was collected for analysis of rheumatoid factor and antinuclear antibodies. Silicone was observed microscopically in at least one capsule section from all implant cases and in at least one lymph node in 8 of 15 implant cases. Silicone was not observed in lymph nodes from control cases. Organosilicon polymers were extracted from tissue using heptane, and the silicon content of the extract was quantitated by atomic absorption spectrometry. Silicon was detected in all capsules; statistically significant increases of organosilicon polymers were measured in axillary lymph nodes, breast, and abdominal fat from individuals with silicone breast implants when compared with the nonimplant group. Measurable amounts of organosilicon polymers were found in tissues from the nonimplant group. Suitable blood specimens were analyzed for the presence of rheumatoid factor and antinuclear antibodies. All nine implant cases tested were negative for the presence of antinuclear antibodies. Three implant cases which were tested for rheumatoid factor also were negative. We conclude that organosilicon polymers routinely migrate from the site of breast implantation to regional tissues near the implant site. Tissues from nonimplant cases often contained measurable amounts of organosilicon polymers, and tissue distribution was variable within any single individual: this is consistent with the wide-spread use and form of organosilicon polymers.     

Quantitative monitoring of capsular contraction around smooth and textured implants

The purpose of this study was to assess the efficacy of textured silicone implants in reducing the incidence of capsular contracture. Each of 10 female New Zealand, albino rabbits received 2 saline-filled implants, 1 on either side of the lateral chest wall. The surface of 1 implant was smooth silicone, whereas the other implant's surface was textured silicone. Magnetic resonance imaging (MRI) scans of the implants were performed at 0, 9, 17, 26, 34, and 40 weeks after implantation. Data from the MRI scans were used to calculate the effective surface area of implants at each analysis interval. This technique provided a noninvasive method of monitoring implant contraction as a function of time. Eight rabbits completed the study. Four of 8 smooth implants developed contractures, whereas none of the textured implants developed contracture. For the 4 smooth implants that developed contractures, MRI scans calculated 72 +/- 12% contraction at 17 weeks, but the Baker palpation test detected only mild firmness. From 17 to 40 weeks, the mean percentage of contraction for these implants changed minimally, but their mean Baker score increased from mild to severe (II to IV). Quantitative data from MRI scans were much more predictive of final implant contraction than palpation (Baker test), applanation tonometry, or indentation tonometry. The latter two tests only detected the final stages of severe implant contraction.     

Kinetical analysis of tumor cell death-inducing mechanism by polymorphonuclear leukocyte-derived calprotectin: involvement of protein synthesis and generation of reactive oxygen species in target cells

Nasal reconstruction presents a significant challenge to the facial plastic surgeon. Reestablishment of the desired aesthetic nasal contour and restoration of respiratory function are the dual goals of this endeavor. While autologous cartilage or bone is considered optimal grafting material, the supply is often limited and harvesting entails additional morbidity. Many synthetic materials have been introduced for use in nasal reconstruction, but high infection and extrusion rates have left most surgeons dissatisfied with conventional implants. Porous polyethylene (Medpor) implants were used for nasal reconstruction in 187 patients; 66 (35.3%) patients underwent primary rhinoplasty, while revision surgery was performed in 121 (64.7%) patients. Most patients required multiple implants, including columella struts, plumper grafts, dorsal tip implants, and nasal valve battens. Postoperative follow-up ranged from 6 months to 3.5 years. Complications occurred in five (2.6%) patients. Three early and two delayed infections necessitated implant removal in five patients, all of whom had compromised skin-soft tissue envelopes secondary to heavy smoking, cocaine abuse, or prior surgery. One case of an overly augmented nasal dorsum and tip required implant removal, reduction, and reinsertion. All implants were easily removed. No other complications including implant extrusion or skin erosion have been noted. Porous polyethylene (Medpor) implants allow for fibrovascular ingrowth, which lends stability to the implant. Porous polyethylene implants are well tolerated and provide an ideal material for nasal reconstruction.     

Lymphocyte response to silica among offspring of silicone breast implant recipients

The current study evaluated immune response to silicon dioxide in children born to women with silicone breast implants. In part one of the study, the T lymphocytes of 21 of 24 such children were significantly stimulated by silicon dioxide (silica). Part two consisted of eleven children, four born preimplantation and seven born postimplantation. None of the preimplant offspring showed T cell responses to silica; five of the seven postimplant children were positive for T cell memory for silica. Part three was a blinded study based on statistically significant differences in T cell stimulation with silicon dioxide between postimplant children and controls. These findings indicate a common immune reaction, that of T cell memory, occurs in mothers and their children born after exposure to silicone mammary implants placed prior to pregnancy. Since not all such children were breast fed the result favors transplacental passage of immunogens such as silicone oligomers or through maternofetal cellular traffic.     

Strength of silicone breast implants

Rupture and leakage are recognized problems associated with silicone breast implants. Data are scarce about the durability of the silicone shell, and the life span of this device is unknown. The purpose of this study was to investigate the strength of silicone breast implants. Thirty implant shells were subjected to mechanical testing. Twenty-nine of the shells were tested after explanation, and one unused implant served as a control to validate the testing method. Implantation time varied from 4 months to 20 years, and all shells were tested, regardless of condition. Fourteen implant shells were intact, eight were leaking, and seven were ruptured. All ruptured implants had been in place for 10 years or longer. The breaking force of all excised shell specimens ranged from 2.6 to 22.4 N (0.6 to 5.0 lb.). Specimens from the control "high performance" shell required 15.5 to 25.6 N (3.5 to 5.8 lb) of force to fail. The weakest group was from thin-shelled implants between 10 and 16 years of age. More than half these specimens failed with less than 1 lb of force. The average breaking force of ruptured shell material was less than that of intact shells. A comparison of strength data in this study with manufacturers' data suggests that breaking force is dependent on implant type, shell thickness, and implantation time.