Transvaginal Mesh Lawsuit - Pelvic Mesh Recall Compensation

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 becomes 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 pelvic 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 depends upon individual circumstances and courts. Generally, the clock starts ticking on the date the injury occurs. But when issues with a mesh implant are not immediately apparent, a judge might determine that the clock did not start ticking until the patient first experienced adverse side effects from the implant because that is when an “injury” actually occurred.

Every person’s case is unique when it comes to the specifics of the statute of limitations. To see what the statute of limitations 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 in 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.

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 help with compensation for future medical care. Thousands of woman have already filed a claim to get compensation for mesh implant injuries.

Transvaginal mesh claims have been 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 of mesh implants allegedly share similar design flaws and associated risks.

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

Are you suffering the devastating consequences of mesh removal surgery, erosion, or organ perforation from a Coloplast mesh product? Baron & Budd is currently seeking victims injured from transvaginal mesh complications. Contact our firm to see if you qualify for a Coloplast mesh lawsuit.

Coloplast is a manufacturer and supplier of many different products, including transvaginal mesh used in pelvic organ prolapse (POP) surgical repair. The company has world headquarters in Denmark with a U.S. headquarters in Minneapolis. Coloplast is just one of many manufacturers of mesh products used for POP and stress urinary incontinence (SUI) that were sued by women who suffered from serious complications from the use and exposure to the mesh products.

Serious Coloplast Mesh Complications

In 2008 the FDA issued its initial warning to healthcare providers and patients regarding rare but serious complications when surgical mesh is used to repair pelvic organ prolapse (POP) and urinary incontinence.  Complications reported by the FDA that were previously unknown include:

•   Mesh Erosion
•   Mesh Contraction
•   Shrinkage
•   Organ Perforation
•   Bowel Perforation & Rupture
•   Bladder Perforation & Rupture
•   Infection
•   Blood Vessel Perforation
•   Sepsis
•   Permanent Damage from Mesh Removal

In 2011 the FDA issued an updated warning that complications are NOT uncommon  when synthetic surgical mesh is implanted through the vagina. When surgical mesh is inserted through the vagina during POP repair surgery, it is called transvaginal mesh.

Coloplast Mesh Products with Known Problems

Problematic Coloplast mesh models with complaints of serious side effects include:

• Aris sling system
• ArisMD
• Aris Transobturator Tape
• Restorelle
• Supris Suprapubic Urethral Sling
• Novasilk

What is Mesh Erosion?

Mesh erosion, also called protrusion, extrusion or exposure, is the most common and most serious complication of transvaginal mesh used for POP and SOI repair. When mesh erodes, part of the implant can protrude through the vagina while the other side of the mesh is fused into your organ tissue. Mesh erosion is a very painful and dangerous complication.

Additionally, eroded mesh may break away and travel through the tissues. If this happens, the only solution is to remove the mesh, which may require several operations and, even then, it may be impossible to remove all of the mesh. Mesh removal typically requires several surgeries and is likely to result in organ removal, permanent damage, and will have devastating effects on the quality of the patient’s life.

How is Mesh Contraction and Shrinkage Dangerous?

When vaginal mesh contracts or shrinks, the patient usually experiences vaginal shortening or tightening, bleeding, and severe vaginal pain. The pain can be unbearable and compromise the quality of the patient’s life.

How Can Mesh Perforate Organs?

When a vaginal mesh implant erodes, the pieces of mesh that break away can travel to other organs and puncture them. Pieces of mesh can also impale blood vessels, causing internal bleeding.

Organs most often perforated by eroded mesh migration include the bladder, rectum, bowel or urethra. Punctures in any of these eliminatory organs can cause an internal infection.  An infection from a punctured bowel can rapidly transform into sepsis if waste from the bowels gets into the bloodstream. Sepsis can kill quickly.

Watch Out for Symptoms of Complications

Symptoms associated with Coloplast and other transvaginal mesh problems include, but of course are not limited to:

• Fever and malaise indicating an infection. This needs to be checked out quickly. Sepsis, a life-threatening infection, begins with symptoms of an infection, including a fever. If not promptly treated, sepsis can lead quickly to death.
• Severe pelvic pain.
• Painful intercourse. If the mesh is eroding and exposed,  in addition to the woman suffering severe pain, a man’s penis may be painfully injured during intercourse.
• Vaginal discharge.
• Incontinence.
• Nerve damage.
• Autoimmune disorders.
• Sepsis.
• Death.

These are only a few of the symptoms associated with complications from mesh implants for POP treatment. If you have a transvaginal mesh implant and experience any or all of these symptoms, contact your doctor right away. These symptoms may signal one of the dangerous side effects that are not uncommon with several Coloplast mesh models.

Coloplast Mesh Settlements and Lawsuits

Hundreds of Coloplast mesh lawsuits have been filed against for its defective product design, failure to properly test mesh products before putting them on the market, and for failure to warn about the potential dangers of the use of its product.

In March 2014, Coloplast settled 400 lawsuits for $16 million. When divided, it came to about $40,000 for each plaintiff. The company made it clear that even though it had engaged in settlements, it was not willing to admit that the products were flawed or unsafe.

The settlement agreement contained a very unusual provision prohibiting the plaintiffs from revealing any details about the settlement.

In addition to paying the $16 million, the company set aside another $186 million for future litigation in anticipation that more women would be filing lawsuits. In September 2015, Coloplast increased its set-aside amount to $457 million.

Coloplast issued a statement after the 2014 settlement that the company was not going to disclose any more details regarding the number of pending claims in the future. However, a publicly available transcription of a conversation between Lars Rasmussen, the CEO of Coloplast, and a mediator, it is clear that litigation is ongoing.

It is still known that Coloplast must deal with at least 1200 more lawsuits that have been filed in federal court and an unknown number in state courts. Plus, its woes are not over. Complications of mesh may not appear for several years after the implant, so it is almost inevitable that there are still more lawsuits yet to come.

Consult with an Experienced Attorney

If you suffer complications after a transvaginal Coloplast mesh implant, contact the mesh lawsuit attorneys at Baron & Budd for a free case evaluation.  A member of our team will discuss your case and determine whether you qualify to file a claim. There are strict time limits for filing a lawsuit and statute of limitations laws unique to product liability cases that vary by state. Don’t let time run and lose your opportunity to file a claim.

Boston Scientific manufactures a large number of medical devices. On its website, it portrays its mission as being “dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.”

Nowhere on its website does it mention the thousands of lawsuits that have been filed against it by women who were injured by its Pinnacle Pelvic Floor Repair Kit (Pinnacle).

The company does not refer to the millions and millions of dollars it has paid to settle just a fraction of those lawsuits, nor does it mention that thousands are still pending resolution.

Also left out of Boston Scientific’s self-praise is the fact that despite its voluntary recall of the product in May 2011, and its massive payout to settle a few lawsuits in 2015, there are new lawsuits still being filed.

Boston Scientific was the first manufacturer of transvaginal mesh with its ProGen product, which it recalled in 1999. Even so, the ProGen was used as a model by other manufacturers before they, too, had to recall their vaginal mesh products.

In 2004, the company introduced to the worldwide market its Pinnacle Pelvic Floor Repair Kit. Thousands of women suffered from complications of the Pinnacle mesh implant, and it was finally recalled in 2011.

Pinnacle Mesh Recall, Pelvic Floor Repair Kit

In 2011, Boston Scientific voluntarily issued a Class II recall of its Pinnacle mesh.   A Class II recall means the use or exposure to the product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

The thousands of women who were injured by the implant of the mesh would likely disagree with this recall definition since they suffered irreversible and serious adverse health consequences.

Serious Complications from Boston Scientific Brand Mesh

The most serious complications from Boston Scientific ProGen mesh and Pinnacle mesh models that were recalled are organ perforation and erosion. The most problematic vaginal mesh products manufactured by Boston Scientific and its subsidiaries include:

•   Pinnacle Pelvic Floor Repair Kit
•   Transobturator Tape (TOT)
•   Transvaginal Tape (TVTO)
•   Obtryx Transobtuator Urethral Sling System
•   Prefyx PPS Sling System
•   Uphold LITE Vaginal Support System Sling

What is Mesh Erosion?

Mesh erosion occurs when the mesh wears through the vaginal wall. It can even protrude through the vagina to a degree that it becomes  visible. This makes intercourse extremely painful and sometimes impossible. Erosion can lead to frequent urinary tract infections and to incontinence, a condition for which the mesh was installed in the first place. Often times removal is one’s best chance at eliminating the pain. Unfortunately,  mesh removal is not always successful, and can require several operations. The removal of an eroded mesh has been likened to “cutting gum out of hair.”

How Can Vaginal Mesh Perforate Organs?

The erosion of the vaginal mesh can lead to organ perforation when small pieces of eroded mesh break off and become lodged, puncturing surrounding organs. The organs most commonly penetrated by mesh migration are the bladder, bowel, rectum and urethra. A perforated bowel or bladder can leak contents into the bloodstream, causing serious infection, even sepsis. Sepsis is a serious infection of the blood that can be fatal.

There are also a number of other serious complications that can occur from mesh vaginal mesh implants.

• Nerve damage.
• Fistulas.
• Sepsis.
• Organ perforation.
• Vaginal scarring.
• Degradation of the mesh.
• Painful mesh shrinkage.
• Infections, most commonly of the urinary tract.
• Autoimmune disorders leading to rejection of the mesh.
• Recurrence of the prolapse which led to the original need for surgery.
• Organ Removal.

Symptoms of a Serious Mesh Implant Complication

If a woman experiences any of these symptoms, she should consult her doctor to determine if she is suffering from a serious complication from her vaginal mesh implant.

• Severe pain in the groin area.
• Bleeding from the urinary tract.
• Vaginal bleeding.
• Blood in the stool.
• Vaginal or abdominal pain.
• Fever.
• Mesh erosion or protrusion.
• Mailaise.
• Painful or impossible intercourse.

When the mesh has begun to protrude through the vagina, but is not yet visible, intercourse is painful for both the man and the woman.

Boston Scientific Mesh Settlements and Lawsuits

By March 2014, 16,700 transvaginal mesh lawsuits were pending against Boston Scientific. Allegations are that the company knew the product was defective but continued to market it anyway. It failed to warn about the dangers of the product.

In 2015, the company paid $119 million to settle approximately 3,000 of the lawsuits. Many more lawsuits have been filed since that time. As of June 2016, thousands of claims were still unsettled.

Contact an Attorney Who is Experienced with Mesh Litigation

If you had a transvaginal mesh implant and are experiencing any symptoms of serious complications, contact the attorneys at Baron & Budd. We have the experience and expertise you need on your side. We offer a free case evaluation so we can review your potential case and see if you’re eligible to file a claim. Call  now to speak with a member of our firm about filing a lawsuit against Boston Scientific, the manufacturers of your mesh implant responsible for your suffering.

Sources

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100416

For 2004 intro of Pinnacle

http://www.fda.gov/downloads/Training/CDRHLearn/UCM2092 81.pdf

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsCorrectionsAndRemovals/