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There is continuing concern that women who receive breast implants may be at increased risk for adverse reproductive outcomes or experience problems with breastfeeding. It is unknown whether exposure to biomaterials in breast implants may have teratogenic effects or leach into breast milk causing postnatalproblems. We studied the Food and Drug Administration (FDA) experience by analyzing a case series of adverse event reports received and entered into the FDA's Manufacturer and User Facility Device Experience (MAUDE) database or the Device Experience Network (DEN) database by December 31, 2002 regarding women with breast implants. Reports were critically reviewed for lactation difficulties, reproductive problems (spontaneous abortion, delayed conception) and medical conditions among offspring, including neonatal, infant, and childhood diseases and congenital defects that were attributed to implants. We identified 339 reports that described maternal-child adverse events. Nearly half of these reports (46%) described actual problems with breastfeeding or expressed concern that implants would be unsafe or interfere with breastfeeding. Forty-four percent of reports (n=149) described either nonspecific or specific signs, symptoms, or illnesses in children. An additional 3.5% of reports (n=12) detailed a congenital anomaly believed by the reporter to be caused by breast implants.

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Breast pumps are medical devices used to express milk and maintain the milk supply. The purpose of this study was to characterize adverse events reported to the United States Food and Drug Administration (FDA) on breast pumps. Thirty-seven adverse event reports on breast pumps were identified from the Manufacturer and User Facility Device Experience database between 1992 and 2003. Four additional reports were found in the Device Experience Network database from 1992 to 1996. The most commonly reported adverse events for electric breast pumps were pain, soreness, or discomfort; the need for medical intervention; and breast tissue damage. Most frequently reported problems for manual breast pumps were breast tissue damage and infection. Contamination of breast milk during pumping was also reported. Breast pump adverse events are likely underreported to the FDA. Reporting adverse events is important for improving the design and manufacture of breast pumps and subsequently decreasing adverse events.

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BACKGROUND: Use of stapling devices has become standard practice in many operations, and these devices have many applications, including ligation and division, resection, anastomosis, and fascial closure. The Food and Drug Administration (FDA) regulates surgical staplers as a medical device. Manufacturers and health-care providers report adverse events occurring during the use of surgical staplers to the FDA. STUDY DESIGN: Two FDA adverse event databases, the Manufacturer and User Facility Device Experience database and the Alternative Summary Reporting database were searched for adverse events related to the use of surgical staplers. An FDA recall database, Oracle System Center Automated Retrieval, was searched for surgical stapler recalls and the reason for these recalls. RESULTS: We characterized adverse events from 112 death, 2,180 injury, and 22,804 malfunction reports from FDA adverse event databases. We described 22 recalls for these products that are listed in an FDA database. A majority of these recalls were related to manufacturing or design problems. CONCLUSIONS: The overall incidence of these events remains unknown; because these products are used so frequently, even uncommon adverse events may affect many patients. It is important for health-care providers to report adverse events to manufacturers so that they may work to improve the design of these devices and reduce use errors that contribute to the events.

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OBJECTIVE: To characterize reports of adverse events occurring during mammography to women with breast implants submitted to the Food and Drug Administration (FDA). METHODS: We searched the adverse events database for any report on silicone gel breast implants or saline breast implants that included the word "mammography" or "mammogram"in the text. We also searched adverse event reports for mammographic equipment that included the term "breast implant" in the text. RESULTS: We retrieved 714 adverse event reports using this strategy. Sixty-six of these reports detailed an adverse event that occurred during mammography or described breast implant interference with mammography. The majority of these reports, 41 of 66 (62.1%), described breast implant rupture during mammography. Other adverse events reported included mammographic compression crushing implants, pain during mammography attributed to implants, inability to perform mammography because of capsular contracture or fear of implant rupture, and delayed detection of cancer attributed to implants. CONCLUSIONS: It is important that women considering breast implants be informed of these potential risks and that clinicians, radiologists, and mammographic technicians keep them in mind when imaging women with implants.

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A silicone adjustable gastric banding system was approved by the Food and Drug Administration (FDA) in June, 2001. The purpose of this report is to review and characterize the reports on silicone adjustable gastric banding systems received by the FDA through August 8, 2002. We also review medical literature on adverse events with silicone adjustable gastric banding systems. Manufacturers of regulated medical devices, such as adjustable silicone gastric bands, are required to report adverse events, including deaths and serious injuries, to the FDA. We reviewed all such reports received by the FDA through August 8, 2002, for adjustable silicone gastric bands and summarize the data by type of adverse event, reported device problems, and reported patient problems. The FDA received 556 reports of adverse events related to the use of adjustable silicone gastric bands. Two of these reports were for deaths, one during surgery and the other as a result of an erosion of the gastric band into the stomach 9 weeks after implantation. Forty-four reports were for injuries including band erosions, slippage, and infection. The most common type of report (499) was for device malfunction, and of these, 485 (97.2%) described a leak at or near the port. Of the 485 leaks reported as malfunctions, 99.4% were treated surgically. The majority of reports were related to disconnection, breakage, and leakage at or near the access port. Physicians and potential patients should be aware of these problems and recognize the possibility that additional surgery(ies) may be required for leaking access port/connections. The loose connection may cause pain and the device no longer performs as intended when there is a leak.

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OBJECTIVE: Etanercept and infliximab are tumor necrosis factor (TNF) antagonists that have been recently approved for the treatment of rheumatoid arthritis (RA) and Crohn's disease (CD). This study was undertaken to investigate the occurrence of lymphoproliferative disorders in patients treated with these agents. METHODS: Relevant data in the MedWatch postmarket adverse event surveillance system run by the US Food and Drug Administration were reviewed. RESULTS: We identified 26 cases of lymphoproliferative disorders following treatment with etanercept (18 cases) or infliximab (8 cases). The majority of cases (81%) were non-Hodgkin's lymphomas. The interval between initiation of therapy with etanercept or infliximab and the development of lymphoma was very short (median 8 weeks). In 2 instances (1 infliximab, 1 etanercept), lymphoma regression was observed following discontinuation of anti-TNF treatment, in the absence of specific cytotoxic therapy directed toward the lymphoma. CONCLUSION: Although data from a case series such as this cannot establish a clear causal relationship between exposure to these medications and the risk of lymphoproliferative disease, the known predisposition of patients with RA and CD to lymphoma, the known excess of lymphoma in other immunosuppressed populations, and the known immunosuppressive effects of the anti-TNF drugs provide a biologic basis for concern and justification for the initiation of additional epidemiologic studies to formally evaluate this possible association.

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OBJECTIVE: Two tumor necrosis factor alpha (TNFalpha) antagonists were recently licensed in the US. Infliximab was licensed in 1998 for the treatment of Crohn's disease (CD), and since 1999, it has been licensed in combination with methotrexate for treatment of rheumatoid arthritis (RA). Etanercept was licensed in 1998 for treatment of RA and, more recently, for juvenile RA and psoriatic arthritis. Because of potential immunosuppression related to use of anti-TNFalpha agents, we sought to identify postlicensure cases of opportunistic infection, including histoplasmosis, in patients treated with these products. METHODS: The US Food and Drug Administration's (FDA) passive surveillance database for monitoring postlicensure adverse events was reviewed to identify all reports received through July 2001 of histoplasmosis in patients treated with either infliximab or etanercept. RESULTS: Ten cases of Histoplasma capsulatum (HC) infection were reported: 9 associated with infliximab and 1 associated with etanercept. In patients treated with infliximab, manifestations of histoplasmosis occurred within 1 week to 6 months after the first dose and typically included fever, malaise, cough, dyspnea, and interstitial pneumonitis. Of the 10 patients with histoplasmosis, 9 required treatment in an intensive care unit, and 1 died. All patients had received concomitant immunosuppressive medications in addition to infliximab or etanercept, and all resided in HC-endemic regions. CONCLUSION: Postlicensure surveillance suggests that acute life-threatening histoplasmosis may complicate immunotherapy with TNFalpha antagonists, particularly infliximab. Histoplasmosis should be considered early in the evaluation of patients who reside in HC-endemic areas in whom infectious complications develop during treatment with infliximab or etanercept.

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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.

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Silicone breast implants have been marketed in the United States since 1963. Questions remain unanswered on the safety of these medical devices despite their popularity and availability. In 1992, the Food and Drug Administration restricted the availability of silicone-gel breast implants to women requiring them for reconstruction after breast cancer or for other medical indications. Inflatable saline breast implants have remained available for either reconstruction or for cosmetic augmentation while manufacturers completed studies addressing issues of safety and effectiveness. The Food and Drug Administration (FDA) has less concern today regarding a putative association between breast implants and autoimmune disease because of epidemiologic studies that have indicated that there is not a large increase in risk for connective tissue disease in women with breast implants. These studies have not ruled out a small increase in risk of connective tissue disease to these women nor have they addressed the issue of an atypical syndrome related to silicone. The FDA has continuing concerns over local complications that are related to breast implants. The current review provides a brief discussion of the regulatory history of silicone implants and of FDA concerns over breast implants, implant prevalence, studies of systemic and local complications related to breast implants, and a brief description of the FDA study of silicone-gel breast implant rupture.

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BACKGROUND: This study examined the prevalence of revision surgery in which silicone gel breast implants were either removed (explanted) or replaced in a cohort of women from Birmingham, Alabama. The main reason leading up to the surgery and the prevalence of ruptured implants reported after explantation are described. METHODS: Data were collected from telephone interviews with 907 women previously identified in a larger cohort study of women with breast implants. Women who reported breast surgeries subsequent to their index mammoplasty were asked to consent to retrieval of the surgical records describing the surgery. RESULTS: Surgery in which a silicone gel breast implant was removed or replaced was reported by 33% of the 907 women in this cohort. The most common reason for surgery was problems with the implant that affected the breast (103 of 303 surgeries). Of the 303 women reporting surgery, 145 (48%) reported knowing after a surgery that an implant was ruptured when it was removed, and 171 (56%) reported knowing that an implant was ruptured or leaking. Overall, 16% of the 907 women reported knowing that either of their implants was ruptured after any surgery. At least one surgical record was retrieved for 165 (54%) of the 303 women reporting surgery. Among these women, the rupture rate was 69 of 165 (42%) according to the surgical record and 85 of 165 (51.5%) according to self-reports, a statistically significant difference (p = 0.008 from McNemar's test). The mean time from implantation to surgery was 11.5 years among women reporting surgery and estimated at 21.4 years for all women. CONCLUSIONS: A third of the women in this cohort underwent additional surgery after the initial mammoplasty, and nearly half who underwent surgery reported that their implants were found to be ruptured when removed. Women considering silicone gel breast implants should be informed of the risk of additional surgeries and of the potential risk of breast implant rupture.

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OBJECTIVE: We sought to identify pitfalls in recognition of extracapsular silicone on MR imaging. MATERIALS AND METHODS: Three experienced observers reviewed MR images from 359 women with current (n = 320), prior (n = 15), or both current and prior (n = 24) silicone gel implants. Axial and sagittal fast spin-echo T2-weighted images with water suppression, axial inversion-recovery T2-weighted images with water suppression, and axial T2-weighted images with silicone suppression were obtained in a dedicated phased array breast coil on a 1.5-T magnet. Images were reviewed again when only one observer saw extracapsular silicone, and reasons for disagreement were recorded. RESULTS: Rupture was identified in 265 women (77%) with current silicone implants and 378 (55%) of 687 implants. Observers agreed in describing extracapsular silicone in 85 (12%) of 687 breasts with current silicone gel implants, of which 81 (95%) showed definite evidence of rupture on MR imaging. One observer reported extracapsular silicone in another 79 breasts. Confusion over contour deformity due to weakening versus breach of the capsule accounted for 33 (42%) of 79 disagreements. Another 20 (25%) of the 79 disagreements were attributed to poor conspicuity of extracapsular silicone on fast spin-echo T2-weighted images combined with intermittent observer failure to review inversion-recovery images. Subtlety of findings (n = 17, 22%) and technical issues (n = 9, 11%) with failed water suppression of pleural effusion or cysts and ghosting artifacts accounted for remaining disagreements. CONCLUSION: Extracapsular rupture is usually manifest as local spread of silicone in the breast and is not well-depicted on fast spin-echo T2-weighted images. Water-suppressed inversion-recovery T2-weighted images are often needed to identify extracapsular silicone. Distinction of the bulge in the fibrous capsule from herniation through the capsule remains problematic.

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Platinum is used as a catalyst in the manufacture of silicone breast implants. Because platinum is recognized as a potent sensitizer in certain circumstances, some have expressed concern that women with silicone breast implants are exposed to platinum, which is causing allergic reactions. We searched the literature for information on the level of platinum in breast implants and reports of sensitization that clearly related to platinum in women with breast implants. We found no published report with convincing evidence that platinum causes allergic reactions in women with breast implants or that women with breast implants are any more likely to have allergic reactions than women without breast implants.

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