Transvaginal Mesh Lawsuit – Pelvic Mesh Recall Compensation

Surgical mesh materials like transvaginal mesh, pelvic mesh, and hernia mesh are supposed to help make patients better. Unfortunately, many mesh implant patients have had severe setbacks requiring repeat surgeries. Sometimes these surgeries cannot repair the injury caused to the pelvic lining, vagina, or organ. Surgical mesh is used during or after a hysterectomy, pelvic organ prolapse surgery, surgical procedures to repair hernias, to repair atrial septal defects (holes in the heart), and for stress urinary incontinence surgery (SUI). But when surgical mesh is implanted in the pelvis through the vagina, it is then called transvaginal mesh. Transvaginal mesh is used specifically to stabilize pelvic tissue before or after a hysterectomy, for SUI treatment, and during POP repair surgery.

It may be hard to believe, but transvaginal mesh was never specifically tested for use in vaginal repairs. This is part of what led to a large number of transvaginal mesh lawsuits filed by women who have suffered serious and life-changing injuries after transvaginal mesh implant surgery. Our attorneys have also stepped up to help women who have been harmed by dangerous pelvic mesh implants. Join the thousands of women who have stood up against Big Pharma by filing a transvaginal mesh lawsuit today. Contact an attorney at our firm who concentrates specifically on cases with defective medical devices and implants at 866-520-2755 or request an appointment online at complete our contact form.

Have you undergone a second surgery for prolapse or have been told that you need another surgery? It may be related to complications with the transvaginal mesh or pelvic mesh used in your surgery.

The sad fact is that transvaginal mesh was never tested for vaginal repairs or pelvic repairs, but it was still used for these procedures. Instead, the material was intended for and has been used to successfully repair hernias for years, was put on the FDA’s fast-track approval system, called the 510(k), which does not require testing prior to market release.

What Transvaginal and Pelvic Mesh Implant Manufacturers Have Been Sued?

The largest manufacturers of dangerous surgical mesh include Johnson & Johnson, Bard Medical, Boston Scientific, Endo Pharmaceuticals, Coloplast, and Cosurg to name a few.

Only after reviewing published scientific research from 1996 to 2011 did the FDA discover that transvaginal mesh repairs of pelvic prolapse (vaginal repairs) often failed to fix the symptoms of prolapse or improve the patient’s quality of life as compared to non-mesh repair treatments. This has led to numerous transvaginal mesh implant lawsuits by victims who have had to endure repeat surgical procedures, pain, and suffering.

Why Our Attorneys are Your Best Choice for Transvaginal Mesh Claims

Baron & Budd co-founder and shareholder Russell Budd currently serves on the Plaintiffs’ Steering Committee for transvaginal mesh litigation.

On April 3, 2014, a transvaginal mesh injury victim was awarded a verdict in one of the first mesh implant lawsuits. This result will help set a precedent for future vaginal mesh cases. Read more.

Do You Qualify? – 866-520-2755

Request Your Free Case Review
If you or someone you know has had organ prolapse or urinary incontinence surgery and later required a revision surgery, please contact us immediately to see if you qualify to file a pelvic mesh or  vaginal mesh lawsuit for compensation.

Why Should Surgical Mesh Manufacturers Should Pay?

As noted by the FDA, the common complications of the transvaginal mesh recall device are serious and include infection, pain, recurrence of prolapse, urinary problems, incontinence and erosion through the vaginal epithelium. The FDA also discovered that transvaginal mesh often shrinks once inside the patient, causing vaginal tightening and pain. Additionally, there have been many reported cases of bowel, bladder and even blood vessel perforation during the insertion of transvaginal mesh. There have also been reports of vaginal scarring, discomfort and pain including dyspareunia, leading to a significant decrease in patient quality of life due to transvaginal mesh erosion.

Transvaginal mesh litigation began as a response to the physical and emotional pain suffered by transvaginal mesh patients. In particular, transvaginal mesh claims have helped to pinpoint the unnecessary risks that mesh implant patients encountered.

Serious and life-threatening problems have been associated with transvaginal Mesh.
Transvaginal mesh is a type of surgical mesh similar to a woven fabric that is inserted through the vagina during pelvic surgery. Transvaginal mesh was used to create a pelvic or bladder sling to help reinforce the vaginal wall. Most often, transvaginal mesh was used to treat two conditions commonly suffered by women: pelvic organ prolapse and stress urinary incontinence.

Pelvic organ prolapse (POP) is a condition that occurs when the tissue that keeps the pelvic organs in place become stretched or weakened. Between thirty to fifty percent of women may experience pelvic organ prolapse in their lifetime, with two percent of women developing symptoms. The symptoms of pelvic organ prolapse involve a bulging (or prolapse) of organs into the vagina, sometimes even past the vaginal opening. Organs that can prolapse include the uterus, the rectum, the bladder, the bowel and the top of the vagina (vaginal apex), often after a hysterectomy. Sometimes referred to as pelvic floor disorder, more than one pelvic organ can prolapse at the same time.

Stress Urinary Incontinence (SUI) involves a leakage of urine in moments of physical activity such as exercise or coughing, sneezing or laughing.

Both pelvic organ prolapse and stress urinary incontinence tend to occur in women after childbirth, hysterectomy or menopause.

First used in the 1990s for this treatment, pelvic mesh was thought to permanently fix pelvic organ conditions. However, serious problems associated with the mesh have led to multiple pelvic mesh lawsuits.

Transvaginal Mesh Erosion

Unfortunately, the most common problem associated with pelvic mesh is also the most dangerous: mesh erosion. Also known as mesh extrusion, pelvic mesh erosion occurs when the rough edges of the synthetic mesh cut through the vaginal lining, uterus, bladder, or other nearby organs.

Both pelvice and transvaginal mesh erosion causes organ perforation, bleeding, infection, pain while sitting, walking, or during intercourse and urinary problems. In addition, the FDA warns that there are also reports of recurrent prolapse, neuromuscular problems, vaginal scarring, pelvic scarring, and emotional problems as a result of implanting the mesh. Less severe side effects of the transvaginal mesh recall treatment include urinary incontinence and constipation.

There were over 75,000 pelvic and vaginal mesh surgeries performed in 2010 and at least ten percent of these resulted in failure. Women who have experienced problems with the mesh often turn to urogynecologists, who are specialists in the area, to help reverse the surgery. However, reversing the damage done by pelvic or transvaginal mesh is not always possible. Some women undergo multiple operations to remove pieces of the mesh yet these revision surgeries do not always relieve the complications. Removing the mesh is particularly difficult as tissue grows in and around the mesh and multiple surgeries are often needed. Surgical removal of the mesh is painful, costly and dangerous, involving both lengthy recovery periods and a high risk for further problems.

In addition to revision surgeries, some women must also undergo restorative treatments for transvaginal mesh issues including IV therapy, blood transfusions, and drainage of hematomas and abscesses.

Increasingly, medical experts report that complications with vaginal mesh are inevitable – meaning, if complications do not occur right away, they likely will occur within a few years of transvaginal mesh placement.

Under the law, there is a limited amount of time to file a lawsuit for harms related to transvaginal mesh implants. This time period is called the “statute of limitations” and is different in every state. In some states, the time period is as short as just one year, while in other states it can last for up to four years. It’s important to contact an attorney as soon possible to find out what the statute is in your state. Keep in mind: if you do not pursue a lawsuit within the time limit allowed by your state, you will never be able to seek justice for your injuries caused by dangerous mesh implants.

You may be wondering: how do I know when the clock starts ticking? When I first had my surgery? When I first started having issues with the mesh?

The answer, unfortunately, is not entirely clear at this point in the litigation. Generally, the clock starts ticking on a statute on the date of the injury. However, in many cases issues with the mesh implant are not immediately apparent, and, in other cases, some judges have stated that the clock started running when the patient experienced any adverse symptoms after the first mesh implant surgery.

Every person’s case is unique when it comes to the specifics of the statute. To see what the statute is in your state, we recommend that you contact an attorney as soon as possible to discuss your specific situation.

One is the earliest date that some companies began to recall the mesh device amid safety concerns. The first transvaginal mesh lawsuits, in fact, date back to the early 1990s when Boston Scientific Corp. pulled its ProteGen mesh device from the market – later settling nearly 1,000 transvaginal mesh litigation cases over its mesh device. Then, in 2006, Mentor Worldwide responded to several reports of problems by removing its ObTape mesh from the market. Another fact cited in transvaginal mesh litigation is Johnson and Johnson’s recall of four mesh products, Gynecare TVT Secur System, Gynecare Prolift, Gynecare Prosima and Gynecare Prolift + M, July 2012.

Transvaginal mesh litigation has spotlighted the many FDA warnings for transvaginal mesh use in surgery. One such warning occurred in 2008, when the FDA made a public health notification listing the serious complications specific to transvaginal mesh revision surgery. In another warning in 2011, the FDA warned surgeons and patients that using transvaginal mesh to repair pelvic organ prolapse puts patients at greater risk than other surgical treatment options. Another FDA report, dated July 2011, disclosed that transvaginal mesh prolapse repairs between 2008 and 2010 caused thousands of injuries and seven deaths. The same FDA warning also stated that there is no evidence that transvaginal mesh use ever improves prolapse surgery outcomes.

Why did some companies continue to manufacture and sell transvaginal mesh devices when there was substantial proof of risks associated with transvaginal mesh use? Why did some companies continue to manufacture and sell transvaginal mesh when other companies paid heed to the problems and pulled their own devices from the market?

Transvaginal mesh lawyers are working to uncover the answers.

Currently, transvaginal mesh has not been completely recalled from the market, although the FDA’s Obstetrics and Gynecology Devices Advisory Committee did assist in reclassifying the transvaginal mesh device as Class III, meaning all future devices must undergo premarket approval to ensure safety and effectiveness. In January 2012, the FDA also required all transvaginal mesh manufacturers to perform three-year studies on their products to determine the device’s side effects and the effects on the patient’s overall quality of life.

The majority of people involved in these lawsuits blame mesh manufacturers, not the individual surgeons who implanted their mesh device. This is because surgeons typically relied upon the information given to them by the mesh manufacturer and the FDA. And, unfortunately, while the FDA issued several warnings regarding transvaginal mesh, the warnings were insufficient given the high number of severe transvaginal mesh side effects and other problems.

Do You Qualify? – 866-520-2755

Request Your Free Case Review
Suffering from complications due to transvaginal mesh revision surgery, you may be able to file a transvaginal mesh lawsuit.

A woman who participates in a lawsuit against mesh implant manufacturers may be able to receive financial help to cover medical expenses, lost wages and related expenses as well as to help compensate for future medical care. Thousands of woman have already filed a claim to get compensation for mesh implant injuries.

The lawsuit was consolidated into multi-district litigation because of the many lawsuits that were filed regarding similar issues with transvaginal mesh – even though transvaginal mesh is manufactured by a number of different companies. The mesh lawsuit involves five companies: American Medical Systems, Boston Scientific Corp, C.R. Bard, Johnson & Johnson and Coloplast. Each of these companies’ various models, allege the mesh implants share similar design flaws and associated risks.

To participate in the transvaginal mesh lawsuit, give us a call at 866-520-2755 today. Our mesh implant lawyers will offer you a free and confidential consultation to determine if you qualify for a transvaginal mesh lawsuit.

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Contact an Attorney for Vaginal or Pelvic Mesh Implant Injuries

Contact Baron & Budd today to schedule a free consultation with our team. Our team of pharmaceutical lawsuit attorneys have decades of experience handling injury claims for defective medical devices like mesh, and they can help you  get the compensation you deserve for your pain, suffering, and mental anguish.