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Transvaginal mesh device approval process draws scrutiny

April 12th, 2012

The president of Consumer Reports has spoken out against the Food and Drug Administration approval process that allowed devices such as transvaginal mesh to be used in patients without full regulatory scrutiny. In an email sent to more than one million recipients, Jim Guest called the approval process “a nightmare scenario.”

Guest claims that the regulatory process which manufacturers use to get approval for surgical mesh and other devices without human safety trials has lead to recalls of 700 different products every year. Consumer Union—the advocacy arm of Consumer Reports—has said it will make its campaign to change the approval process a top priority.

Transvaginal mesh has been the subject of major recalls by manufacturers such as Johnson & Johnson and Boston Scientific. Patients who received the device have complained of device failure, leading to severe tissue damage, limited mobility and pelvic organ prolapse.

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