Posts Tagged 'transvaginal mesh'

Consultant: Scrutiny forcing FDA to tighten standards

The federal Food and Drug Administration is becoming stricter about its process for approving medical devices, according to a consultant for regulatory affairs. Those changes are coming about in response to scrutiny and criticism over a process that allows devices to be approved based on their similarity to devices already on the market.

A recent article in the Electronic Engineering Times quotes consultant Chris Henza, who spoke at the DesignMed professional conference in California.

Henza said the 510(k) process, which employs the ...

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Many transvaginal mesh implants were unnecessary, caused complications

A Consumer Reports article on the hazards of certain medical devices recommends that patients protect themselves by considering what alternatives are available.

In the case of transvaginal mesh implants, for example, patients should ask their doctors what will happen if they don’t get the devices. According to the report, many women who received transvaginal mesh for pelvic organ prolapse – where the pelvic organs move out of alignment because of weakened muscles – never needed the surgery.

The report quotes Daniel S. ...

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Consumer Reports: Medical device approval process deeply flawed

A new issue of Consumer Reports includes an investigation into the process by which the federal Food and Drug Administration reviews medical implants for approval.

The report concludes that most medical devices aren’t tested before being implanted in patients’ bodies. The situation amounts to what’s essentially a large-scale medical experiment carried out on unwitting test subjects, made up of members of the public.

“For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and ...

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Mother who lost job from implant wants reforms

A mother of three who had to quit her truck-driving job because of debilitating pain from a faulty vaginal mesh implant spoke up on Thursday, calling for federal lawmakers to close the loophole that allowed the implant to go on the market in the first place.

“It’s a question of loss,” said Colorado resident Jay Nevarez. “I lost my job and my health, and am in the process of losing my home.”

According to a report in The Boston Globe, Nevarez joined ...

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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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