According to Bloomberg, Johnson & Johnson continued selling a vaginal mesh implant for nine months after the U.S. Food and Drug Administration ordered the company to stop.
In a letter from August, 2007, the FDA told Johnson & Johnson to halt sales of Gynecare Prolift until the agency decided whether the device was “substantially equivalent” to other products on the market. The letter cited the “potential high risk for organ perforation” ...
continue reading...In an article devoted to women’s urinary incontinence, Mayo Clinic staff members acknowledge that talking about bladder control problems is difficult.
But the article urges women who experience bladder control problems to get help, because the condition is treatable and not all doctors routinely ask about urinary function during an exam.
“Leaking urine, having to urinate frequently and experiencing other symptoms of urinary incontinence aren’t trivial consequences of childbirth or a natural ...
continue reading...One of the dangers of transvaginal mesh devices, according to an article in The Trial Lawyer magazine, is that they typically can’t be removed once they’ve been implanted in a patient’s body.
This is bad news for the thousands of implant recipients who have reported problems including debilitating pain and organ perforation after the devices have started to erode. According to The Trial Lawyer, doctors can trim ...
continue reading...A story in the Spring, 2012, issue of The Trial Lawyer magazine takes a look at the flaws in the federal approval process that allow dangerous transvaginal mesh kits to be implanted in women, with disastrous results.
The article is called “Transvaginal Pelvic Organ Prolapse Kits: The Chronicle of Failure.” It describes a system in which representatives of medical device companies frequent the offices of OB/GYNs and surgeons, urging them to ...
continue reading...Even as Johnson & Johnson has announced its intention to stop selling vaginal mesh implants, at least one other company intends to continue marketing them despite reports that the devices are severely injuring thousands of patients.
A Bloomberg report quotes Blaine Davis, Endo Health Solutions senior vice-president for corporate affairs, as saying: “As a company, we’re very committed to these categories. We are actually investing behind these products.”
Davis said the company, ...
continue reading...Johnson & Johnson has requested that the U.S. Food and Drug Administration allow the company 120 days to take four types of vaginal mesh implants off the market, despite widespread complaints that the devices are causing severe injuries for women who receive them.
Johnson & Johnson said in a statement that the action is not technically a recall.
Vaginal mesh implants are used to treat urinary incontinence and pelvic organ prolapse, which occurs when muscles are weakened – ...
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