Articles Posted in transvaginal mesh

The U.S. Food and Drug Administration this week issued an order to immediately halt the sale and distribution of pelvic mesh product for treatment of pelvic organ prolapse.vaginalmesh-300x225

Boston Scientific and Coloplast are the only two companies in the U.S. still selling mesh to treat pelvic prolapse. The FDA order immediately prohibits the sale of Boston Scientific’s Uphold Lite and Xenform mesh products, as well as Coloplast’s Restorelle DirectFix.

Our medical device injury attorneys have been watching the issue closely as tens of thousands of women have been seriously injured by mesh implantation. Still, Boston Scientific and Coloplast have continued to market and sell the product 7 years after the FDA issued an emergency order mandating device makers prove their products are safer and more effective than traditional surgical repair.

Transvaginal mesh is a surgical implant designed to treat women with various conditions, including pelvic organ prolapse (POP).  This medical product was marketed as a minimally invasive means of treating these conditions. But after implantation, many women experienced painful side effects such as tearing of tissue, abrasion of vaginal tissue, and many other painful conditions for which they were not warned by Boston scientific, – the maker of many transvaginal mesh  (TVM) implants.

Boston products liability cases Surgical mesh is nothing new. It had been used to treat heart patients for many years, an even to treat various reproductive disorders in women. But transvaginal mesh was marketed as a new and effective treatment. The company managed to get it passed U.S. Food and Drug Administration (FDA) review, despite a real question as to whether adequate safety testing was performed and whether manufacturers properly notified FDA of any complications they knew or should have known about. Continue reading

Transvaginal mesh, or “TVM” as it is often called, was not originally developed to be used to treat medical conditions affecting the female reproductive system. Surgical mesh has been around for many years, and, as that name implies, it is a woven medical grade textile that is used to reinforce a part of the body, such an organ that has experienced erosion.

sadVaginal mesh was adapted from the already existing forms of surgical mesh and was marketed as basically a cure-all for women’s health issues.  If you were suffering from pelvic organ prolapse (POP) for example, a surgeon could implant the mesh in a simple outpatient procedure, and you would be back to normal.  This would also allow you to fix issues like stress urinary insentience. Continue reading

In one recent case from the U.S. Supreme Court for the Fourth Circuit, a plaintiff, along with her husband, filed a lawsuit against Eithicon, the makers of a of popular transvaginal mesh medical device that has been the subject of numerous products liability lawsuits.

sadIn this case, plaintiff testified that after having the Ethicon (Johnson & Johnson) device implanted, she started to experience serious complications that resulted in significant pain and suffering.  In this case, the device was known as a Tension-Free Vaginal Tape-Obdurator. This device is typically referred to by its abbreviated name, TVT-O.   Continue reading

In California, the state attorney general recently announced her office would be pursuing legal action against drug manufacturer Johnson & Johnson for its alleged false advertising and deceptive marketing of its vaginal mesh products.woman

Now, Johnson & Johnson has fired back on those claims,with a spokeswoman telling Legal Newsline that the decision to sue the company was not just, and that the company has no plans to settle the case. Instead, it plans to fight the allegations vigorously.

Of course, it likely has no choice. To concede that it deceptively marketed or falsely advertised would be to put ammunition in the hands of thousands of plaintiffs who are still waiting for their day in court with the medical product manufacturer.  Continue reading

Boston Scientific Corp. is a named defendant in some 36,000 product liability lawsuits related to its surgical mesh devices, also sometimes referred to as pelvic mesh, pelvic slings or transvaginal mesh. These devices have been touted as a means to repair a host of pelvic disorders in women, but instead, they have proven extremely dangerous. womanwindow

Now, the company is doing something it probably should have done long ago: Updating its safety warnings.

Of course, it shouldn’t take 35,000 lawsuits to prompt this kind of action from a pharmaceutical manufacturer, but better late than never. The question some people might have, though, is whether the safety warnings will have any impact on their ability to bring a civil lawsuit against the firm. The answer is probably not, so long as the surgery took place before the safety warnings were updated. Each individual case will be different, and there will be a lot of factors to consider, which is why we encourage anyone who suspects they may have suffered injury as a result of these devices to seek immediate legal counsel. Continue reading

Pharmaceutical giant Johnson & Johnson is facing down two lawsuits filed by attorneys general in California and Washington for failure to disclose the risks associated with their pelvic mesh – also known as vaginal mesh – devices. woman2

As it now stands, the company is already a named defendant in 25,000 personal injury lawsuits filed by U.S. consumers over the surgical mesh, which is touted as a means to shore up weakened pelvic muscles and help to control urinary incontinence. But plaintiffs – overwhelmingly women – say that’s not what happened.

Instead, they allege this device was both defectively designed and defectively manufactured and that Johnson & Johnson failed to warn consumers of the potential risks. As a result, tens of thousands of woman and their families have suffered profound adverse effects, from intense and chronic pain, urinary dysfunction, inflammation and loss of sexual function or incredible pain during sexual intercourse.  Continue reading

According to recent news from the Legal Reader, Johnson & Johnson, a major pharmaceuticals firm and medical device manufacturer, has agreed to settle as many as 3,000 of the products liability lawsuits it is now facing related to its transvaginal mesh implant device.

to-sign-a-contract-2-1221951-mThe reported amount of the settlement is $120 million, and it involves claims that its transvaginal mesh products caused pelvic erosion, extreme pain and discomfort, and internal organ damage as a result of manufacturing and design defects, as well as failure to adequately warn potential victims. While many lawsuits are still ongoing, somewhere between 2,000 and 3,000 of the claims will be dismissed as part of this settlement. Continue reading

The United States Food and Drug Administration (FDA) has recently issued a press release dealing with new changes to regulations regarding the use of transvaginal mesh (TVM) implants.

hospital-hand-1100587-mSurgical mesh has been around for decades. In the 1950s, surgeons used the material to repair hernias. Two decades later, surgeons began experimenting with the use of surgical mesh to treat a serious medical condition in women known as pelvic organ prolapse (POP).   However, at that time, surgeons would make an incision in the patient’s abdomen to implant the mesh, and this led to a longer and more painful recovery than many patients would have liked. Continue reading

Stress Urinary Incontinence is a disease that causes pain, discomfort, and embarrassment to thousands of women in the United States each year. There are a variety of things than can lead to this condition, including childbirth, being overweight, and aging. The pelvic muscles become weak and urethral sphincter no longer functions properly. When this happens, the patient will often urinate without warning whenever there is pressure applied to the abdomen. This pressure can cause by sneezing, coughing, lifting, running, or a multitude of other normal everyday activities.

texture-072-1142165-mDoctors have some non-surgical methods to treat stress urinary incontinence, but they are generally not effective, and surgery is normally the option of choice. Surgery involves implanting a sling that holds surgical mesh in a manner that supports the urethra. It is important the mesh, which is actually a form of surgical tape, is tension free, so that is the reason the sling is used, rather than attaching the mesh directly to the area in need of support. Continue reading

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