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Transvaginal Mesh (TVM) Problems, Lawsuits & Updates

Transvaginal Mesh: So small, but so dangerous.

For a little piece of synthetic fabric, a transvaginal mesh can do a great deal of damage. Tens of thousands of women have had transvaginal mesh (TVM) devices surgically implanted, and many of those women have experienced the severe pain that these devices can cause. The manufacturers of TVMs – also called pelvic mesh devices – know that these devices can be dangerous. In fact, they knew about it before the devices ever reached the market. But Big Pharma didn’t think it was in your interest to know about. And they were right. Big Pharma’s only interest is their own bottom line. The simple truth is that the makers of transvaginal mesh devices put their profits before your health. That’s why women around the country have been filing lawsuits against the unethical practices of these giant medical-device makers. If you’ve suffered from health problems from a transvaginal or pelvic mesh device, the first thing you should do is contact your doctor. The second thing you should do is contact the expert attorneys at TheLawFirm.com. The attorneys at TheLawFirm.com are experts in pelvic mesh cases, and we can help you with yours.

What is transvaginal mesh?

At first glance, transvaginal mesh – also known as a pelvic mesh and urogynecologic surgical mesh – is a simple, straightforward device. It’s a small piece of medical-grade fabric that can be surgically implanted to treat a couple of different medical disorders. Surgeons typically implant transvaginal mesh devices in patients who have one of two conditions: Stress Urinary Incontinence (SUI) and/or Pelvic Organ Prolapse (POP). Stress Urinary Incontinence, or SUI, is a condition in which a woman can lose part or all of her bladder function, usually at moments of high stress, such as coughing, exercise, heavy lifting, or sneezing. A transvaginal mesh can help reinforce the bladder, thus permitting greater control over urination. Pelvic Organ Prolapse, or POP, is the other of the two common conditions that is often treated with a pelvic mesh device. In women with POP, the muscles in the pelvic (hip) region weaken, and allow internal organs to shift position, or prolapse. A pelvic mesh can help reinforce the vaginal wall, thus lessening the likelihood that organs will shift in place. Sometimes, transvaginal mesh devices are implanted after a hysterectomy is performed. A TVM, in these cases, can help prevent against the vaginal collapse that is sometimes a side effect of the hysterectomy procedure.

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What are the health hazards associated with pelvic mesh?

The dangers associated with TVM devices are determined by the materials from which they are made. There are two types of TVM devices: those made to be partially or fully absorbed by the body, and those that are not intended to dissolve. Absorbable TVM devices, which are often made from sterile, protein-rich animal tissue, pose relatively few problems. By the time they dissolve, they have done their job in providing a kind of “scaffold” over which the body will regrow new, stronger tissue. Non-absorbable pelvic mesh devices, however, are a different story. Non-absorbable TVM devices are typically made from a cheap plastic called polypropylene – the same stuff used to make fishing line. Polypropylene pelvic mesh often deform, shrink, or twist when implanted in the body, and those changes in shape are what causes problems. When a pelvic mesh gets literally bent out of shape, its edges can fray; when those edges fray, they can slice into the sensitive internal tissues of the vagina, the rectum, the bladder, and the uterus. Many women who have non-absorbable TVM devices have reported severe pain during sexual intercourse. Polypropylene pelvic mesh devices have been implicated in many cases of internal bleeding, infection, and urinary problems. In the worst cases, these conditions can cause life-threatening infections, and even death. Any of these problems can require a woman to undergo even more surgery. So-called “revision surgery” to remove these dangerous devices is expensive, and opens patients up once again to the risk of infection and surgical complications. Often, in revision surgeries, doctors find that the TVM is so thoroughly intertwined with the body’s own tissues that it cannot be entirely removed. So it stays inside the body forever, where it may continue to cause severe health conditions. All of these problems from a little piece of fabric.

How safe are pelvic mesh devices?

Short answer: not very safe. A short history of the transvaginal mesh device is quite enlightening. TVMs were approved by the U.S. Food and Drug Administration (FDA) in 2002, and were classified as a Class II, or moderate-risk, treatment for SUI and POP. By 2008 – after hearing more than 1000 complaints that linked TVMs to bleeding, infection, organ perforation, pelvic pain, urinary difficulties, and vaginal scarring – the FDA issued a formal warning about the devices. By 2011, thousands more complaints had been filed, prompting the FDA to issue a second warning about pelvic mesh. The agency stressed that POP can be treated without the use of pelvic mesh, which were associated with serious risks. Then the lawsuits came in. By 2014, more than 60,000 lawsuits had been filed against the makers of TVM devices. Sixty thousand – that’s a number approximately equal to the population of Rapid City, South Dakota. That’s a lot of lawsuits. Yet a number of major medical-device manufacturers still make, market, and sell pelvic mesh devices.

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Why are TVM devices still even on the market?

Why aren’t these medical-device companies afraid of facing all of those lawsuits? Short answer: because, even if they have to settle a bunch of lawsuits, these companies can still turn a major profit on their TVM devices. These corporations actually budget for lawsuits when they devise new products. To them, it’s just the “cost of doing business.” A cost that women pay with their suffering – and sometimes with their lives. Look at these numbers: • A court ruled in a 2015 case that a pelvic mesh manufacturer had to pay $3.6 million. • In another 2015 case, a TVM maker had to pay $12.5 million. • In another case in 2015, the major medical-device manufacturer Bard paid $200 million to settle 3000 TVM cases against it. That’s only about $66,000 per case – not much, considering all the pain, suffering, and expense that each woman endured. • In 2016, Johnson & Johnson agreed to pay $120 million to settle more than 2000 pending pelvic mesh cases. • In a separate case, Johnson & Johnson was ordered to pay $13.5 million in a suit about its Ethicon transvaginal mesh. The thing is, though, that, to Johnson & Johnson, a figure like $133.5 million is like pennies to us. In 2016, Johnson & Johnson’s revenue was nearly $72 billion. For Johnson & Johnson, paying a $133 million legal bill is the mega-corporation equivalent of buying a pack of gum.

Why file a transvaginal mesh lawsuit?

You’ve probably heard that the wheels of justice turn slowly. That may be so. But, now, 15 years after pelvic mesh devices first received FDA approval, the wheel of justice has finally come around. If your life and health have been adversely affected by the surgical implantation of a pelvic mesh device, there has never been a better time to file a lawsuit The time is right to file a pelvic mesh lawsuit. Other plaintiffs have won. You can win, too. We hope that, if you decide to file a pelvic mesh lawsuit, you will allow us to help you with it. The attorneys at TheLawFirm.com are experts in researching and trying cases involving TVMs. We believe that your health is far more important than the profit margins of Big Pharma. We believe Big Pharma has been dishonest, greedy, and negligent in creating, marketing, and selling TVM devices. Contact us for your free consultation. At TheLawFirm.com, we will advocate for your health – always.

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