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pelvic floor disorders 72 articles

Feds approve new tracking process for medical devices

Medical devices will now be manufactured with a code that will help them be tracked in order to gauge safety issues and notify recipients in the event of a recall as part of a new rule passed this week by federal regulators. The new process assigns a unique device identifier, or UDI, to each device, which provides basic information such as manufacturer name, type of device, model, and expiration date. Some devices may include batch lot numbers to help identify devices in the event of a recall. UDI information will be stored in a database that is accessible to the public; ... Read More

Woman sues transvaginal mesh maker over injuries

“When they come out with a product and make it sound like a cure-all, I don’t know about other women, but I jumped at the chance to get it fixed,” Lee* told The Salt Lake Tribune about the transvaginal mesh device designed to treat her stress urinary incontinence. Unfortunately, the promise was too good to be true. Transvaginal mesh is a surgical mesh device that is used to treat pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. The device is inserted through the vagina to hold up organs that have dropped, or prolapsed. The conditions are ... Read More

J&J sold transvaginal mesh product against FDA’s orders

Johnson & Johnson continued to sell its transvaginal mesh product for nine months after the Food and Drug Administration (FDA) told the company to stop marketing the controversial device, court records show. This discovery could lead to higher awards in the more than 1,400 lawsuits filed against Johnson & Johnson’s Ethicon unit by women who say the mesh caused organ perforation, pain, scarring and nerve damage. In a letter dated August 24, 2007, the FDA told Johnson & Johnson to stop sales of Gynecare Prolift until the agency could determine whether the device was “substantially equivalent” to other transvaginal mesh ... Read More

Consumer groups call transvaginal mesh phase-out a small victory

Several Johnson & Johnson surgical mesh implants that have been tied to a growing number of lawsuits will gradually be pulled from the market, a move consumer watchdog groups applaud. The consumer health products giant says it will phase out four of its transvaginal mesh devices over the next three to nine months “in light of changing market dynamics,” the company said in a statement. Johnson & Johnson says the phase-out is not a recall and the decision to stop making the mesh is not due to complaints. Consumer groups say fewer transvaginal mesh products on the market is a ... Read More

Transvaginal mesh maker pulls device as lawsuits mount

Johnson & Johnson says it is not recalling its controversial transvaginal mesh devices, but it does plan to discontinue sales of four of the products over the next three to nine months. The consumer health care giant sent a letter about the phase out to judges who are overseeing lawsuits against the company from women who allege they suffered injuries after being implanted with the mesh. Transvaginal mesh is a type of surgical mesh that is used to repair pelvic floor disorders such as pelvic organ prolapse (POP) and sudden urinary incontinence (SUI). It is sometimes referred to as a ... Read More

Another lawsuit filed against makers of transvaginal mesh

Susana Franklin says a device intended to relieve a minor medical annoyance ended up ruining her life, and now she has joined hundreds of women who have filed lawsuits against the manufacturers of the device. In 2007, under the advice of her doctor, Susana was implanted with a type of surgical mesh to treat urinary incontinence. The mesh is a common treatment for pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. It is inserted into the vagina and used to shore up organs that have prolapsed, or dropped, due to obesity, childbirth or age. But the ... Read More

Women should consider risks with transvaginal mesh

Surgical mesh plays a significant role in the successful management of certain pelvic floor disorders but women should be aware of the problems that can occur with the mesh and take measures to minimize their risk, recommends Dr. Lesley K. Carr, urologist at Sunnybrook Health Sciences Centre and associate professor at the University of Toronto’s Department of Surgery. Transvaginal mesh is a device that is used to treat conditions such as stress urinary incontinence and pelvic organ prolapse. The mesh is used to shore up organs that have dropped, or prolapsed, causing symptoms such as urinary incontinence, pain during intercourse, ... Read More

Woman tells of frightening warning signs of transvaginal mesh failure

The first warning sign that Nonie Wideman had that hinted there was a problem with the surgery she had to repair a pelvic floor disorder was when tiny purple fibers started coming out in her urine. More fibers appeared in her vagina. They were from the surgical mesh doctors implanted in her to hold up organs that had dropped, or prolapsed. Neither the problem nor the procedure is uncommon. Pelvic organs often drop in women due to childbirth, weight gain, or age. The condition can lead to problems known as stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Treatment often ... Read More

Women should consider benefits vs. risks before transvaginal mesh surgery

When considering surgery for pelvic floor repairs including stress urinary incontinence and pelvic organ prolapse, one should take a serious look at the surgical mesh device that will be used, says Dr. Lesley K. Carr, a urologist at Sunnybrook Health Services Center and an associate professor at the University of Toronto’s Department of Surgery. Synthetic mesh is commonly used in surgery to shore up organs that may have dropped, or prolapsed, due to obesity, childbirth or age. These tension-free vaginal tapes revolutionized the management of urinary incontinence by allowing a minimally invasive approach to surgery that could be performed under ... Read More

Woman sues bladder sling maker for failing to warn about possible complications

“I never had this before, nothing so bad that you could just sit down and cry. You just don’t know what’s going on with your body.” Canadian resident Diane McLaughlin recalls the severe pain she experienced shortly after surgery in 2006 to correct a problem that was causing her urinary incontinence. The operation involved the transvaginal insertion of surgical mesh to shore up her bladder, which had prolapsed and was causing the embarrassing symptom. But neither her doctor nor the medical device’s literature warned her of the possible risks of the procedure. Transvaginal surgical mesh, also known as pelvic mesh or ... Read More