Breast implant manufacturer under investigation by FDA

Article Abstract:

Mentor Corp is under investigation by the Federal Food and Drug Administration (FDA) for allegations of irregularities in breast implant research. Before the investigation, an advisory panel recommended that the FDA allows Mentor's implants to stay on the market after concluding that they are safe and effective. However, Mentor's general counsel, Douglas Altschuler, argues that the FDA's allegations were baseles, while Rep Tom Bliley questions the credibility of the allegations.

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Disputed saline breast implants can be sold

Article Abstract:

Saline breast implants manufactured by Mentor Corp and McGhan Medical Corp were allowed by the Food and Drug Administration (FDA) on May 10, 2000 to stay on the market 'despite relatively high complication and failure rates.' The agency required the two manufacturers to present brochures detailing the products' risks. While saline breast implants have been available since the 1960s, it was only recently the FDA required implant manufacturers to provide safety and effectiveness information.

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Data: Vioxx might raise heart risk

Article Abstract:

Merck's 'super aspirin' Vioxx might increase the risk of heart attack on arthritis patients, according to a Food and Drug Administration (FDA) advisory committee on Feb 8, 2001. Before the FDA recommendation, Merck had asked the advisory committee that Vioxx should not have note on its label similar warning about gastrointestinal complications as other non- steroidal anti-inflammatory drugs. The advisory committee based its recommendation on a study of over 8,000 patients that compared Vioxx with naproven, sold as Aleve.

Pharmaceutical Preparation Manufacturing, Aspirin, Merck and Company Inc.

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