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Did the FDA Adequately Review Silicone Breast Implant Safety Data?

Posted on January 11, 2012

Consumer safety groups want to know if the U.S. Food and Drug Administration (FDA) actually looked at safety data before declaring silicone breast implants safe last year. The Washington Post quotes the National Research Center for Women and Families in a January 4 story stating that one in five, or 20 percent, of women will have to have their silicone breast implants removed and/or replaced within five years because of complications. The FDA decided last summer that silicone implants are basically safe, but that women must understand what can go wrong. An outside FDA panel of experts echoed the same conclusion and decided the controversial implants should stay on the market.

In a letter to the FDA, the group’s president asked why industry shows a decline in complications in silicone breast implants over time, and also questioned why the FDA did not share information from industry studies that show women seem to suffer a reduction in emotional and physical well-being after they’ve had the implanted breast medical devices.

The controversial implants are made by Allergan Inc. and Mentor, a division of Johnson & Johnson, who provided the FDA with data on safety and effectiveness in an eight and 10-year study.

Silicone gel breast implants have been controversial for more than 20 years. They were banned from the market in 1992 for fear the defective implants might cause cancer or auto-immune diseases. From 1992 to 2006, only saline implants were available for women who wanted to enhance their breast size or who requested implants following breast surgery. But silicone-filled implants returned to the market in 2006 with the FDA requiring the manufacturers to conduct post-implant studies.

A product is considered defective if it causes harm to the user. A defect can be in the manufacturing of the product, its design, or in its marketing. Farah & Farah’s Florida product liability attorneys understand how to determine where the defect exists and hold the manufacturer and those in the line of distribution responsible for your injuries.

Source: http://www.washingtonpost.com/business/technology/womens-health-advocates-question-fda-about-missing-safety-data-on-silicone-breast-implants/2012/01/05/gIQA2LO4cP_story.html