Evaluation of a hepatitis A immunization program.

BACKGROUND: The purpose of this study was to evaluate the effectiveness of a hepatitis A vaccine requirement targeted at child-care center attendees 2-5 years of age in Maricopa County, AZ. A case-control study conducted before implementation in 1997 found that individuals with hepatitis A were 6 times more likely to have worked in or attended a child-care center than were matched controls, and 40% of hepatitis A cases were attributable to attending or working in a child-care center. METHODS: A case-control study was conducted postimplementation in 1999. Cases were individuals reported to surveillance staff between August 1, 1999 and April 30, 2000. Cases were included if they met the Centers for Disease Control and Prevention hepatitis A surveillance case definition. Each case (n = 72) was matched to 2 controls (n = 144) based on age and neighborhood. RESULTS: Cases were more likely to have had contact with a hepatitis A case [odds ratio (OR), 7.04; 95% confidence interval (CI), 1.96, 25.31] than were their matched controls in the unadjusted analysis. Individuals with direct contact with a child-care center (OR 0.221; CI 0.05, 0.99) were protected against disease. In the multivariate analysis, contact with a hepatitis A case (OR 5.63; CI 1.22, 25.91) was significantly associated with disease, and the protective effect of education (OR 0.19; CI 0.06, 0.60) remained significant. CONCLUSION: The results of this study suggest the vaccination requirement had some impact on the epidemiology of hepatitis A in Maricopa County. The risk associated with child-care centers seen in the 1997 study is no longer significantly associated with hepatitis A disease.

Adjustable silicone gastric banding adverse events reported to the Food and Drug Administration.

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.

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.