Transvaginal Mesh Lawsuit

Bloomberg: J&J sold mesh implant before FDA approval

According to a Bloomberg report, Johnson & Johnson sold a vaginal mesh implant for three years before the federal Food and Drug Administration approved the device.

The report says Johnson & Johnson introduced the Gynecare Prolift device in March 2005 without appropriate clearance. The FDA learned of the device in 2007 when Johnson & Johnson was trying to get approval for a related device.

The FDA approved both devices in 2008, after Johnson & Johnson took advantage of a loophole that obliges ...

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Departing Johnson & Johnson CEO Weldon getting $143.5 million

Departing Johnson & Johnson Chief Executive Officer William C. Weldon, who is leaving after a spate of disastrous recalls, will get $143.5 million in retirement pay, according to Bloomberg.

Bloomberg reports that Weldon, 63, will remain chairman. He amassed $95.1 million in deferred and long-term compensation during his 40 years with the company, and his pension has a present value of $48.4 million.

The report mentions that the company struggled with recalls of artificial hip implants and over-the-counter drugs, and safety concerns ...

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Consumer group calls for reform of FDA approval process

The independent nonprofit Consumer Reports has undertaken a national campaign to change the process by which the federal Food and Drug Administration approves medical devices, according to a report in the Chicago Tribune.

Consumer Reports says the agency’s approval of metal-on-metal hip implants and transvaginal mesh implants – both of which have led to thousands of reported cases of debilitating health problems — illustrate why reforming the process is necessary.

According to the Tribune, Consumer Reports President Jim Guest sent an email ...

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Medical groups voice concerns about transvaginal mesh implants

The American College of Obstetricians and Gynecologists and the American Urogynecologic Society recently issued a joint statement expressing the organizations’ concerns about the safety and effectiveness of transvaginal mesh implants to treat the condition pelvic organ prolapse.

In the statement, the groups say there’s an “urgent need” for a national registry to track outcomes for all current and future patients who get the procedure.

Pelvic organ prolapse occurs when there’s stretching or tearing of the pelvic floor muscles and connective tissue holding ...

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Medical groups voice concerns about transvaginal mesh implants

The American College of Obstetricians and Gynecologists and the American Urogynecologic Society recently issued a joint statement expressing the organizations’ concerns about the safety and effectiveness of transvaginal mesh implants to treat the condition pelvic organ prolapse.

In the statement, the groups say there’s an “urgent need” for a national registry to track outcomes for all current and future patients who get the procedure.

Pelvic organ prolapse occurs when there’s stretching or tearing of the pelvic floor muscles and connective tissue holding ...

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Members of Congress: Close FDA loophole

Four Democratic U.S. Representatives have introduced legislation designed to close a major loophole in the process by which the federal Food and Drug Administration approves medical devices. The legislation’s sponsors specifically cite vaginal mesh implants and metal-on-metal hip implants as dangerous and defective devices that have made it onto the market as a result of that loophole.

A news release from the bill’s main sponsor, ...

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