Depuy Hip Replacements

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 ...

continue reading...

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 ...

continue reading...

Report questions timing of hip implant recall

A major Australian newspaper is questioning why the country’s regulatory agency for drugs and medical devices allowed DePuy’s all-metal hip implants to be sold there for years after data showed they had a high early failure rate.

The report in the Sydney Morning Herald mentions documents the New York Times obtained through the Freedom of Information Act, which indicated that DePuy executives sold the devices in the United States and abroad despite knowing that they were potentially dangerous for patients who ...

continue reading...

New York Times: Company knowingly sold defective implants

Johnson & Johnson executives decided to phase out a replacement hip joint and sell its remaining inventory to be surgically implanted in patients just weeks after the company got a letter from the Food and Drug Administration about serious safety concerns with the devices.

The Times cites documents it attained under the Freedom of Information Act.

A report in the New York Times says that after receiving the letter, company executives waited a year to take the DePuy hip implants off the ...

continue reading...

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 ...

continue reading...

Columnist: Preemptive implant removal a bad idea

A medical columnist for the British newspaper Daily Mail writes that patients should not get all-metal hip implants removed simply because they’re worried over recent reports about the devices.

Dr. Ellie Cannon acknowledged that patients who received the implants in question are likely to be alarmed about two widely reported problems. The first problem associated with these implants is that studies show the all-metal variety of artificial hip fails at a substantially earlier rate than other types, causing pain and loss ...

continue reading...
Page 31 of 32 «...10202829303132