Incidence of silicone breast implant rupture

HYPOTHESIS: The incidence of silicone breast implant rupture varies with implantation time and type of implant. OBJECTIVE: To measure the incidence of implant rupture by repeated magnetic resonance imaging (MRI) among women with silicone breast implants. DESIGN, SETTING, AND PARTICIPANTS: In 1999, 271 women who had received breast implants at least 3 years before, and who were randomly chosen from a larger cohort of women with cosmetic breast implants, underwent a baseline MRI. A second MRI was performed in 2001; 317 silicone implants (in 186 women) that were intact at the baseline MRI (n = 280) or were intact at baseline but removed before the second MRI (n = 37) were included in the rupture incidence analyses. MAIN OUTCOME MEASURES: Implants were diagnosed with definite or possible rupture. Crude and implant age-adjusted incidence rates were calculated, and implant survival was estimated based on the observed rupture rates. RESULTS: We found 33 definite ruptures (10%) and 23 possible ruptures (7%) during the 2-year period. The overall rupture incidence rate for definite ruptures was 5.3 ruptures/100 implants per year (95% confidence interval, 4.0-7.0). The rupture rate increased significantly with increasing implant age. Double-lumen implants were associated with substantially lower rupture risk than single-lumen implants. For modern implants intact 3 years after implantation, we estimated rupture-free survival of 98% at 5 years and 83% to 85% at 10 years. CONCLUSIONS: The risk of implant rupture increases with implant age. A minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation.     

Axillary silicone lymphadenopathy secondary to augmentation mammaplasty

We report a case involving a 45-year-old woman, who presented with an axillary mass 10 years after bilateral cosmetic augmentation mammaplasty. A lump was detected in the left axilla, and subsequent mammography and magnetic resonance imaging demonstrated intracapsular rupture of the left breast prosthesis. An excisional biopsy of the left axillary lesion and replacement of the ruptured implant was performed. Histological analysis showed that the axillary lump was lymph nodes containing large amounts of silicone. Silicone lymphadenopathy is an obscure complication of procedures involving the use of silicone. It is thought to occur following the transit of silicone droplets from breast implants to lymph nodes by macrophages and should always be considered as a differential diagnosis in patients in whom silicone prostheses are present.     

Ultrasound mammography in prosthesis-related breast augmentation complications

Ultrasound mammography is presented as a safe, simple, and reliable method of assessing prosthesis and prosthesis-related complications in the augmented breast. The ability to distinguish between silicone gel, muscle, hematoma, and fluid collections has made ultrasound mammography especially valuable in diagnosing capsular rupture, implant rupture, or periprosthetic hematoma in subpectoral breast augmentations. Examples are given and discussed.     

Morphology of breast implant fold flaw failure

The percent of modern silicone gel breast implants that fail due to shell rupture is quite low, amounting to less than 1% per year. Nonetheless, extensive retrieval and analysis studies are being conducted on failed devices returned to Allergan Medical (formerly Inamed Corporation) in order to determine the modes and causes of failure. With the modes and causes known, solutions can be implemented to eliminate the failure mechanisms. Analyses conducted thus far have demonstrated that there are several causes of breast implant failure. The focus of this paper is on one type of silicone gel breast implant failure, i.e., a failure associated with a fold or wrinkle, which is termed "fold flaw failure." Although fold flaw failure is not a dominant mode of failure for silicone gel breast implants, its failure characteristics must be understood in order for this type of shell rupture to be detected and eventually eliminated. In this study, optical microscopy and scanning electron microscopy are used to describe the morphology of fold flaw failure for explanted silicone gel breast implants with smooth shells. The microscopy analysis demonstrates that there are several different types of shell failure patterns that can be produced by a fold or wrinkle in a silicone gel breast implant.     

Survivorship of breast implants used in breast reconstruction. 949 implants

The authors present from a series of 949 implants their method to calculate the life span of a mammary implant in the framework of breast reconstruction after cancer. In this statistical study, they have calculated the median life span of breast implants (loss of half of staff) by distinguishing it according to each type of implant (content, brand, indication...). The global median life span of a breast implant is 127 months. The median life span of a silicone gel-filled implant is superior than a saline implant because the frequency of deflation of saline implants is more important than the first one, despite that the real rupture percentage of silicone gel-filled implants is under-evaluated by the number of asymptomatic rupture. For saline implants, the median life span is clearly decreased by the initial under-inflation (108 months against 127 months) doubling the secondary deflation risk. In this series, the authors have been able to compare the evolution of implants according to their initial indication (reconstruction or aesthetic) and sometimes at a same patient, they have not observed significant difference of the median life span over a period of five years for an implant used in breast reconstruction after cancer or for an implant used in symmetricalization. In this series, the life span of saline implants is significant different in function of the brand of the implant demonstrating the comparative study usefulness by brands.     

Breast Implant Stability in the Subfascial Plane and the New Shaped Silicone Gel Breast Implants

The author presents his experience with breast augmentation using a next-generation, form-stable, anatomically shaped silicone gel breast implant. Rotation is a potential complication for anatomically shaped breast implants. Anatomically shaped saline implants have been reported to have a rotation rate as high as 14%, while lower rotation rates of 1–2.6% for anatomic cohesive gel silicone implants have been reported. Currently, these implants are limited in the United States to US FDA-approved clinical trials. The author reviews the appropriate surgical techniques to prevent rotation when using these devices. A recent innovation, placement of the superior pole of the implant underneath the superficial fascia of the pectoralis major muscle, is described. Primary and secondary breast augmentations in 241 procedures using the Allergan Style 410 implant resulted in a 0.0% rotation rate. Overall, the anatomic form-stable silicone gel breast implants, when placed subfascially, improve common complications such as capsular contracture and implant rupture with improved aesthetic outcomes and patient satisfaction.     

Intrapulmonary and Cutaneous Siliconomas after Silent Silicone Breast Implant Failure

Abstract: Since the implementation and use of silicone implants in breast surgery the risks are published and discussed. Especially, the incidence of late silicone implant rupture and its potential risk to induce local siliconomas are still under discussion and not sufficiently evaluated. So far literature data offer no information of intrapulmonal or peripheral located cutaneous siliconomas because of systemic migration of silicone after breast augmentation. In light of silicones checkered history, and given the large and growing number of women who choose to undergo breast augmentation surgery each year, the presented clinical findings in our study are likely to be of interest to medical professionals, producers, and consumers alike. We present six female patients with an average age of 55 (±5) years with bilateral rupture of silicone implants after breast augmentation for aesthetic reasons. The average time after operation was 18 (±6) years. In five patients, we identified peripheral located cutaneous siliconomas and one patient suffered from an intrapulmonal siliconoma. The diagnosis of bilateral rupture of the silicone implants was performed preoperatively by MRI‐scans. All five peripheral cutaneous siliconomas and the intrapulmonal siliconoma were validated by histopathologic analysis. Six female patients suffered from bilateral rupture of silicone implants after breast augmentation. In five patients, we identified peripheral located cutaneous siliconomas which were surgically excised. One patient suffered from an intrapulmonal siliconoma. In this unique case a lobectomy with resection of the pulmonal segment 10 had to be performed. Clinical findings of peripheral cutaneous and even intrapulmonary siliconomas after bilateral rupture of silicone breast implants indicate a systemic hematogen or lymphatic pathway of silicone. These findings suggest that it is mandatory to inform the patient about the potential risk of local siliconomas, but also about the potential risk of peripheral cutaneous or even intrapulmonary siliconomas caused by systemic hematogen or lymphatic pathways of silicone after silent implant failure.     

Elemental analysis and clinical implications of calcification deposits associated with silicone breast implants

Calcification of the fibrous capsule surrounding silicone breast implants is a well-recognized occurrence that increases with time following implantation. These mineralized deposits potentially confound mammographic breast cancer surveillance already made difficult by the obscuring effects of silicone breast implants. The authors performed elemental analysis of silicone breast implant-associated calcifications to define better their chemical composition as related to mammographic and clinical significance. Electron probe microanalysis and infrared spectroscopy revealed all of the calcification deposits to be calcium complexed with tribasic phosphate. No evidence of calcium oxalate, calcium carbonate, silicone, or talc was observed. Caution must be employed in interpreting mammograms in women with silicone breast implants as well as those who have had their silicone breast implants removed. High-density mammographic calcifications indicative of calcium phosphate associated with a silicone breast implant may represent an accepted consequence of implantation or nearby carcinoma. We recommend baseline mammography on women who have had their silicone breast implants removed to prevent unnecessary fine-needle aspiration or tissue biopsy of retained breast capsule calcifications during subsequent routine surveillance for carcinoma.     

False-positive radiographic diagnosis of breast implant rupture because of breast abscess.

A case of a periprosthetic abscess simulating breast implant rupture is presented. Both clinical findings and film-screen mammography suggested extravasation of a radiodense material adjacent to an implant. Ultrasonography was thought to confirm the extraluminal silicone. However, at surgery the mass was found to be a breast abscess that had herniated through the capsule. The double-lumen implant outer saline-filled chamber had deflated, but the silicone-containing inner chamber was intact. Magnetic resonance imaging would have distinguished between abscess and silicone.     

Rupture of a silicone gel mammary prosthesis and amyloidosis: a case report

There has been a great deal of controversy regarding the safety of silicone breast implants. Silicone gel prostheses older than 10 years have the risk of either leakage or outright rupture. The role of silicone gel in relation to connective tissue disease or amyloidosis has not been proved by current serologic, immunologic, or epidemiologic tests. In this paper, we present a case with renal amyloidosis and a history of untreated silicone implant rupture for five years.     

Calfplasty

The author describes a method of calf augmentation by a silicone prosthesis implant for correction of asymmetrical legs or aesthetic problems. Preference is given to the placement of soft silicone implants (Glitzentein implants); they are more natural looking than hard implants. The implants are placed over both heads of the gastrocnemius muscle or beneath the fascia cruris superficialis. Operations were performed from November 1985 to August 1999. One hundred patients were studied: 95 female and 5 male. Two hundred calf implants were performed: 188 soft implants (Glitzenstein), 6 hard implants (Aiache), and 6 together on the same leg (Glitzenstein and Aiache implants). No infection problems, prosthesis rupture, or hematomas occurred. There were four seromas, but they disappeared in 15 days. Four prostheses were removed in two patients who did not like the final result. One prosthesis changed place, to the upper part of the calf. The operation is performed under sedative and local anesthesia, with an incision of approximately 4 to 5 cm in the popliteal pleat, at the same height as the fascia cruris. To date, no functional problem or muscular dysfunction has been provoked by silicone prosthesis implants. The patient walks 8 h after the surgery. We selected 500 patients who received implants in the legs with calf prostheses, fat implants, and prosthesis and fat implant together, during 14 years of follow-up, but the focus of this paper is a calf implant with prosthesis in 100 patients with 200 calf prosthesis implants.     

Ultrasound diagnosis of breast implant rupture: beware the atypical presentation and interpret with care

Rupture of silicone breast implants is a recognised complication. We report a 36-year-old lady that 16 years post-augmentation presented with a unilateral gradually swollen breast with no associated lymphadenopathy. Ultrasound examination reported implant rupture, and exchange of implants was subsequently performed, only to reveal serous fluid (negative to culture, cytology and microscopy) and a macroscopically intact implant. A review of the literature has revealed that other imaging modalities are, either in isolation or in combination, more sensitive and specific for implant rupture. We therefore aim to raise awareness of this in the hope that we can potentially prevent further unnecessary operations.     

Sentinel lymph node biopsy in a patient with ruptured poly implant prothese (PIP) implants: A case report

Introduction

Around 400,000 silicone gel breast implants produced by the French company poly implant prothese (PIP) were used worldwide. Following revelations that the company were using non- medical grade silicone for the production of their implants there has been growing concern over the increased rupture rate of these implants and the implications this may have on patients.

Presentation of Case

We report the case of a 57-year old lady with ruptured bilateral cosmetic PIP breast implants in whom a right breast lesion was detected on screening mammograms. Biopsies demonstrated a grade 1 tubular carcinoma. Histology from the sentinel lymph node biopsy showed axillary silicone granulomas but no evidence of metastatic disease.

Discussion

To our knowledge, this is the first reported case to describe SLNB in the presence of ruptured PIP implants, although SLNB in ruptured non-PIP implants has been previously described.

Conclusion

We conclude that SLNB can be utilised even in the context of concurrent PIP implant rupture and the presence of silicone granulomas in the axillary lymph nodes.     

Carboxy-methyl-cellulose hydrogel-filled breast implants – an ideal alternative? A report of five years’ experience with this device

The controversy over the potential health risks from exposure to silicone gel from breast implants has led to extensive research to improve the safety of silicone gel-filled implants. In addition, there has been simultaneous research directed toward the development of alternative filling materials, with the goal of a breast implant that would minimize health risks and maximize cosmetic attributes. In the present study, experience with a filler material that has textural characteristics similar to that of silicone gel, but which is biodegradable and can therefore be eliminated by the body in case of implant failure, is reported.Since February 2000, the authors have been monitoring carboxy-methyl-cellulose (CMC) hydrogel breast implants as participants in a prospective clinical trial. CMC hydrogel is a biodegradable, nontoxic, nonmutagenic and viscoelastic gel, which has been in clinical use since 1984 and has been available as the Monobloc breast implant since 1994. For the present study, 122 patients who underwent surgery between February 2000 and February 2005 were evaluated. It was determined that CMC hydrogel implants have a higher radiotranslucency than silicone gel, and the integrity of this device was easy to prove by clinical examination. In case of rupture, the implant can be replaced immediately; it is easily inserted and can be placed through a small incision because of its highly elastic shell. The complication rate was very low, and the patients were highly satisfied. In terms of safety, the implant is comparable with saline, and its consistency is comparable with that of silicone gel.     

Comparative Study of Breast Implant Rupture Using Mammography,Sonography, and Magnetic Resonance Imaging: Correlation with Surgical Findings

Abstract: Purpose of this study was to evaluate the accuracy of mammography, ultrasonography, and magnetic resonance imaging (MRI), in the detection of breast implant rupture and to make a correlation with findings at explantation. The study population consisted of 63 women with 82 implants, undergoing surgical explantation. Implant rupture status was blindly determined obtaining diagnosis of rupture, possible rupture, or intact implant. Strictly predetermined rupture criteria were applied and compared with findings at surgery, which were considered the gold standard. False‐positives and false‐negatives were retrospectively evaluated to identify pitfalls in the investigation. All associations between imaging signs and surgical findings were evaluated by using chi‐square test. The respective sensitivity and specificity of investigations are reported. Our experience suggests that MRI is the more accurate method for identification of breast implant rupture, even if it should be performed following the diagnostic algorithm proposed.     

不同类型乳房假体隆乳术后并发症的临床分析

目的 统计不同类型的乳房假体置人人体后，远期并发症发生的几率，并分析其原因。方法 总结1993年至2002年间假体隆乳573例，随访到手术方法相同、假体放置位置相同、同一医生组手术的隆乳妇女427例共852只乳房，使用4种不同类型乳房假体：毛面硅凝胶、光面硅凝胶、毛面生理盐水充注式、光面生理盐水充注式乳房假体。出现的远期并发症有纤维包膜挛缩、假体破裂渗漏、疼痛移位等，对各种假体并发症发生率进行统计分析，比较各类假体的优劣。结果 427例852只中803只效果满意，无明显并发症，占94．24％。发生并发症者42例49只乳房，占5．76％。并发症中乳房硬化属Baker‘s分级Ⅲ～Ⅳ级的有26只，缩小变形24只，移位疼痛10只，经手术取出发现假体破裂渗漏的有30只。其中纤维包膜挛缩引起乳房硬化多发生于硅凝胶假体，假体渗漏引起乳房缩小变形多发生于生理盐水充注式假体；假体在体内放置时间越长，发生并发症的几率越高。结论 经统计学处理发现，光面生理盐水假体并发症明显少于光面硅凝胶假体，毛面硅凝胶假体和毛面生理盐水假体并发症发生率没有明显差异。49只有不同并发症的乳房假体中有30只假体破裂渗漏，占61．22％，假体破裂渗漏后又容易引发其它并发症，说明假体质量的提高是减少并发症的关键，长期留置体内假体的老化是目前的难题。     

Accuracy of ultrasonography and magnetic resonance imaging in detecting failure of breast implants filled with silicone gel.

We prospectively studied the accuracy of magnetic resonance imaging (MRI) and ultrasonography (US) for preoperative detection of rupture in 35 single-lumen implants filled with silicone gel in 18 patients. The positive predictive value of US for rupture of an implant was 70% and the negative predictive value 64%. Sensitivity and specificity were 44% and 87%, respectively. Accuracy, defined as the total true positive and true negative values divided by the total number of implants studied was 66%. The positive predictive value of MRI was 100% and the negative predictive value 90%. The corresponding sensitivity and specificity were 88% and 100% and the accuracy 94%. MRI offers significantly better diagnostic sensitivity (p = 0.02) and accuracy (p = 0.004), and should be regarded as the "gold standard" in the evaluation of rupture of breast implants filled with silicone gel. When MRI is not readily available, US is an acceptable alternative.     

Appropriateness of MRI scanning in the detection of ruptured implants used for breast reconstruction.

This case report highlights the problems associated with ruptured silicone breast implants used for breast reconstructive purposes. The patient originally presented with vague symptoms and signs to her GP and was extensively investigated over a period of years for left-sided chest/abdominal pain. Two separate scanning modalities were used prior to her being seen by either of the main authors and although none were employed specifically to assess for implant rupture, neither detected any free silicone around the hemithorax. The authors suggest that patients who have undergone breast reconstruction with a silicone implant may present in a manner not suggestive of implant damage. In such cases, where the silicone can extend over larger anatomical distances and where side-effects can be damaging the investigation of choice should be MRI scanning which has a greater accuracy for detecting free silicone and defining the extent of spread.     

Silicone gel breast implant failure: evaluation of properties of shells and gels for explanted prostheses and meta-analysis of literature rupture data

After 30 years of clinical use, the 1992 Food and Drug Administration moratorium on silicone gel breast implants (SGBIs) resulted from a paucity of scientific data concerning their safety. The frequency of rupture and reoperative procedures was not known, nor were reliable data available for changes in the physical properties of shells and the composition of gels that might lead to SGBI failure. For this reason the authors conducted large-cohort meta-analyses of failure data for SGBIs based on numerous literature reports and also investigated systematically shell and gel properties from explanted SGBIs. They report their failure analysis data for more than 9,770 SGBIs (an update of an earlier study of more than 8,000 implants) as well an examination of the properties of shells and gels for 74 explanted SGBIs that ranged in age from 2 to 19 years (mean implanted age, 9.9 years). The explants tested were from several different manufacturers. For the modest-size explant cohort that was tested, 31 of 74 implants (42%) were found to be ruptured (some extensively). Even many intact shells were so weakened that only 51 shells had sufficient strength to enable preparation of samples for testing of mechanical properties and for analysis of composition by solvent extraction. Shells were found to contain 15 to 25% of extractable silicone. Exhaustive extraction of gels showed that they actually contained very little crosslinked silicone--85 to 95% being extractable soluble silicone fluid. Tensile and tear strengths of explanted silicone elastomer shells were lower than unimplanted prostheses and were generally well below reported manufacturers' values. This updated large-cohort failure analysis continues to show that shell rupture is related directly to implant duration (e.g., from analysis of variance statistics, 26% failure at 3.9 years, 47% at 10.3 years, 69% at 17.8 years; < or = 0.001). However, for the relatively small series of explants for which physical property data are reported, no significant correlation was observed between implant duration and the degradation of implant strength. It therefore appears most reasonable to conclude that after early weakening of shells as a result of swelling of the shell elastomer by diffusion of silicone oil from the gel, SGBI failure can occur in a time-dependent manner as a result of continuing implant motion and cyclic stresses that are exacerbated by stress concentration at thin areas, defects, and folds in the shells.     

MRI for detecting silicone breast implant rupture: meta-analysis and implications

The objective of this study was to assess the accuracy of magnetic resonance imaging (MRI) in detecting silicone breast implant rupture, and to explore implications of the use of MRI for screening and estimating the prevalence of rupture among asymptomatic women. The study consisted of a meta-analysis of published studies with the calculation of sensitivity and specificity as independent parameters, the summary receiver operating characteristic (ROC) curve, and other clinically important values such as positive predictive value (PPV) and negative predictive value. Participants included women with breast implants who underwent both MRI and subsequent implant removal. Eighteen studies, performed primarily in academic settings, with approximately 1,039 women and 2,036 implants met entry criteria. Most studies involved women with symptomatic implants. Assuming that sensitivity and specificity were independent parameters, the summary sensitivity was 78% (95% confidence interval [CI], 71-83) and the summary specificity was 91% (95% CI, 86-94). Using ROC meta-analysis methodology, the odds ratio describing the overall accuracy of the test was 40.1 (range, 18.8-85.4). There was substantial heterogeneity across studies. Studies using breast coils, those with convenience samples, larger studies, and studies of lower report quality tended to report higher levels of accuracy. The quality of study reports was generally poor. Among symptomatic women, PPV was fairly high. Among lower prevalence populations, PPV appeared to be insufficient to warrant use as a screening tool. MRI is moderately accurate in detecting silicone breast implant rupture. However, MRI should remain a confirmatory diagnostic test and should not be used to screen asymptomatic women.