Transvaginal Mesh Lawsuit

Consumer Reports says tracking for implants needed

According to Consumer Reports, a major problem with medical devices in the United States is a lack of any systematic way to keep track of them.

The May issue of the magazine contains an investigation titled “Dangerous Medical Devices,” which examines the flawed federal approval process that allows potentially hazardous devices to go onto the market.

Some of those problematic devices are surgically implanted in patients’ bodies. They include metal-on-metal joint replacements for hips, and transvaginal mesh implants to treat patients suffering ...

continue reading...

CEO may have ties to recalled implants

New Johnson & Johnson CEO Alex Gorsky is already facing some questions regarding his possible involvement with a recalled line of metal-on-metal hip implants, according to a recent report in the Newark Times Ledger.

Gorsky, who started with the company in 1988, is replacing outgoing CEO William Weldon.

Weldon’s departure follows a series of recalls, including medications and devices, that were very damaging for the company. But the Times Ledger article states: “Some critics have already questioned whether Gorsky, who ran the ...

continue reading...

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...

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. ...

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...

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...
Page 28 of 29 «...10202526272829