Articles Posted in transvaginal mesh

According to a recent article from FDA News, Boston Scientific has entered into a private settlement agreement with a plaintiff who was suing the company for injuries she alleged are related their defective transvaginal mesh implant.

This transvaginal mesh lawsuit was being heard before the United States District Court for the Central District of California. Trial has already begun in this case, and there had been about a week of testimony and evidence presented prior to the parties agreeing to settle the matter, rather than letting a jury ultimately decide on the case.
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Transvaginal mesh implants were designed to treat painful and uncomfortable conditions in women, such as pelvic organ prolapse (POP) and stress urinary incontinence. Essentially, if a woman suffered from an inability to hold back the flow of urine or pain in the vaginal walls, doctors would surgically implant one of these mesh implants to correct the problems.

Medical device companies promised women if they had this simple procedure, they would no longer have to live with painful and embarrassing conditions and would get to live a normal pain-free life. While this sounds good, the devices lead to serious problems due to design defects.

Some women suffered an erosion of the vaginal wall, causing extreme pain and suffering, and making sexual intercourse excruciating. Other victims experienced a complete inability to use their pelvic muscles, leading to extreme discomfort and uncontrollable urination. Something sold as the answer to every patient’s dreams was really a nightmare waiting to happen, as our Boston transvaginal mesh injury attorneys have seen all too often.
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In the greater Boston area and across the United States, women have been filing lawsuits against makers of defective transvaginal mesh (TVM) medical devices in large numbers.

According to a recent news article from WBUR, there has been no slowdown of victims coming forward to file cases. Transvaginal mesh implants are used to support sagging pelvic organs and hold them in place. They have been market as a way for women with bladder control issues and other pelvic issues to lead a normal life again, but this is not how it worked out for many victims.

Defectively designed tranvaginal mesh implants have led to serious, painful and often embarrassing medical conditions known as pelvic organ prolapse (POP) and stress urinary incontinence. To make matters worse, doctors have found removing a defective transvaginal mesh implant may not help to fix the damage, because much of it was due to erosion of the vaginal wall while the device was implanted.
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Many women who suffered from urinary incontinence and other medical conditions were told transvaginal mesh (TVM) could solve these problems. Essentially, doctors insert a medical device consisting of a surgical grade mesh, and a suspension system such as sling, into patients in an effort to provide additional support to the vaginal walls and pelvic floor.

Medical device companies advertised their products as being safe and effective at treating these conditions, and would have patients leading normal lives in virtually no time at all.

Unfortunately, many of these devices were defectively designed and not properly tested for efficacy and safety. The result has been many patients now suffer from painful medical conditions such as pelvic erosion, tissue destruction, pelvic organ prolapse (POP), and other serious issues.
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Scott v. C.R. Bard, Inc., an appeal from the Court of Appeal for the State of California, involved a plaintiff who was injured by a polypropylene mesh kit designed to treat women who suffer from a condition known as pelvic organ prolapse (POP). POP occurs when a female patient has weak vaginal walls that allow the uterus and bladder or rectum to enter the vaginal canal. POP can cause serious organ dysfunction, incontinence, pelvic pressure, and extreme pain, even to the point of becoming physically disabled.

Many patients will try less invasive treatment such as pelvic exercise, however, transvaginal mesh (TVM) manufacturers have convinced many POP sufferers that implanting a sling or other device designed to hold a piece of surgical mesh can solve the problem and allow the patient to lead a normal life.
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Boston Scientific Corporation is headed to trial over its Obtryx transvaginal mesh devices, according to a recent report from Reuters. The company has faced complaints from over 23,000 victims who allege that its transvaginal mesh (TVM) implant caused serious personal injury.

The Obtryx device is a transvaginal mesh implant designed to treat pelvic organ prolapse (POP) and a condition known as stress urinary incontinence (SUI). Specifically, Obtryx is a bladder sling made from mesh that is supposed to keep the bladder closed. It was marketed as a minimally invasive solution that would allow women with urinary issues to lead a normal life.
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Our Boston transvaginal mesh attorneys understand for women who are victims of defective Transvaginal Mesh (TVM) products, the impact can be devastating and hard for others to comprehend. According to a news article from The Claiborne Progress, one TVM patient has joined a support group run by a non-profit organization whose mission is to educate and help TVM victims.

The woman interviewed stated that mesh ruined her life. She had a TVM implanted that was defective. The following year, the manufacturer stopped making the product, but there was not much she could do at that point.

About six months after Transvaginal Mesh surgery, she started to experience problems with the implant. Her doctor told her that the mesh had eroded into her bladder after tearing through the vaginal wall. The polypropylene mesh used in her operation has been proven toxic to humans.

She can no longer move without pain, and is now incontinent, and must have the mesh removed. However, removal is a complicated process, as the device must carefully be explanted in pieces over several operations. She already had multiple operations to remove all but two small edges of the transvaginal mesh. Her doctor chose to leave these small pieces in for as long as possible, because they will be dangerous to remove. She knew that she would eventually need them removed, but it was decided that she should wait.

However, now one of those small edges of mesh has perforated her vaginal wall and must be removed.
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According to a recent article from the West Virginia Record, a federal jury has just awarded a plaintiff $3.27 million in a multidistrict litigation (MDL) case involving transvaginal mesh (TVM) products manufactured by Johnson & Johnson.

This case involved the Gynecare TVT Obturator. This device, manufactured by Ethicon, a Johnson & Johnson subsidiary, is a surgically implanted medical device used in the treatment of stress urinary incontinence. The TVM device consists of what is essentially a layer of mesh being held within a support device. The fact that it is supported in this manner is the reason it is called a tension-free vaginal tape (TVT) design, which was marketed as being superior and safer than previous TVM devices that are linked to serious injuries to patients, including erosion of tissue and vaginal dehiscence.

As our TVM plaintiff attorneys in New England understand, these products pose several other risks to women, including erosion of the mesh itself. There is also a risk that, when the device is surgically implanted through incisions made in the vagina and then anchored to the pelvic bone, the patient’s bowel and other internal organs may be perforated (punctured), resulting in internal bleeding, urinary incontinence, and potentially deadly infections.

In this case, the jury found that the drug company had defectively designed the product and failed to adequately warn doctors and patients of known risks. The verdict was in the amount of $100,000 to compensate for medical expenses, $470,000 in pain and suffering and emotional distress that had already been experienced, and $2.5 million for pain and suffering, disability, and loss of enjoyment of life that will likely be experienced by plaintiff in the future. Plaintiff’s husband was also awarded $200,000 in damages associated with loss of consortium.
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According to a recent Bloomberg article, Boston Scientific was found liable and ordered pay $73 million in connection with its Transvaginal Mesh (TVM) medical device.

As our experienced vaginal mesh attorneys in Massachusetts can explain, the product involved in the lawsuit was the Obtryx sling. The Obtryx sling is a device designed to treat women who suffer from stress urinary incontinence and pelvic organ prolapse (POP). The device was fast tracked to the market based upon an FDA policy that allows a product to be sold without additional testing if it similar to a product on the market. Many other manufacturers of TVM products have taken advantage of this loophole in the approval process.

In this case, plaintiffs alleged that, once implanted into the body, the TVM device broke down and cause painful organ damage. Lawyers for the plaintiffs told the jury that women who went to their doctors for minor bladder leaking issues ended up with a life-altering catastrophic result caused by the defective TVM product.
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Incontinence is often associated with post-childbirth complications, but can also be linked to other causes. Health professionals have even linked female incontinence to long-distance running. There has also been significant documentation, online and in the media, about professional athletes who may suffer from incontinence, even while in competition. In a recent article in The Guardian, a runner explores the embarrassing medical condition of incontinence afflicting runners in Boston and throughout the U.S.

One of the traditional ways of treating incontinence has been transvaginal mesh. This is a dangerous product that has left thousands of women in severe pain and requiring reconstructive surgery. Our Boston trans-vaginal mesh attorneys are dedicated to protecting the rights of patients and to helping individuals seek the medical and legal help they need for recovery. In addition to providing advocacy, our team is also abreast of legal and medical issues that may impact our clients.
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