Transvaginal mesh implants are known to cause injuries and long-term health complications that often result in a transvaginal mesh lawsuit against the manufacturer of the device. In the United States, more than 4,000 complaints have been filed with the FDA by injury victims who suffered complications arising from pelvic mesh products.
What Is Transvaginal Mesh?
Transvaginal mesh is a surgical product that is used to give weak or damaged tissue extra support. Most surgical mesh products are man-made in a lab from materials that are strong enough to support internal organs and tissues in the pelvic region of the body. The pelvic floor is a group of muscles and connective tissues that hold major organs including the bladder, cervix, uterus, and vagina in place.
Transvaginal mesh is commonly used to treat patients with both pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. POP occurs when muscles and ligaments surrounding the pelvic organs get weak and fall out of place. SUI is a condition that causes urine to leak out during physical body movements such as jumping, coughing, laughing, and sneezing. When designed properly and inserted correctly, transvaginal mesh and pelvic sling medical devices are used to ensure that the bladder, cervix, uterus, and vagina remain strong to supplement the abdominal muscles that no longer work properly. There are four different types of transvaginal mesh used for POP and SUI patients:
- Absorbable Mesh – Absorbable mesh will degrade and weaken over time, allowing new tissue to grow and provide the necessary support
- Non-absorbable Mesh – Non-absorbable mesh is considered a permanent implant in the body to provide long-term support
- Synthetic Mesh – Synthetic mesh is the most common material used in patients. It comes in knitted or non-knitted sheets which may be absorbable, non-absorbable, or a combination of both.
- Animal Mesh – Animal-derived mesh is made from animal skin or animal intestines from a cow or pig. The animal tissue undergoes disinfection and processing for safety inside the body. Animal-derived mesh is not used as commonly as synthetic mesh, but it is absorbable.
For patients with pelvic organ prolapse (POP), surgery to implant transvaginal mesh is usually done through the abdomen or through the vagina, however, most vaginal surgical procedures no longer use mesh. Surgeons now use sutures (stitches) to repair damaged tissues. For patients with stress urinary incontinence (SUI), surgeons usually implant transvaginal mesh slings through a vaginal cut or two small cuts in the lower stomach. This operation is known as a mid-urethral sling or a mesh sling procedure.
In some patients with POP or SUI, transvaginal mesh implants may be considered unnecessary surgery. This is the case if patients respond well to other alternative treatments, like pelvic floor therapy, which involves specific exercises that strengthen the pelvic floor muscles, or biofeedback and electrical stimulation, which improves the function of pelvic floor muscles.
Possible Complications of Transvaginal Mesh
Over the last few decades, transvaginal mesh products have been used extensively in women to treat POP and SUI conditions. Both of these conditions often plague women following childbirth, hysterectomy, menopause, and strain from lifting heavy objects. Unfortunately, many women who undergo transvaginal mesh implant procedures suffer injuries that warrant a transvaginal mesh lawsuit filed by a personal injury attorney to recover damages. Common complications and injuries include:
- Pain from infections
- Internal bleeding
- Erosion of the transvaginal mesh
- Perforated blood vessels
- Perforated Organs
- Difficulty engaging in sexual intercourse
As a result of transvaginal mesh complications, many women require surgery to remove portions of the mesh from their bodies. However, in some cases, the mesh adheres to the body, which complicates surgical procedures and creates extreme pain for the patient. Due to complications and severe pain, it may be impossible to surgically remove transvaginal mesh implants from a patient’s body.
Before getting transvaginal mesh implants, it’s important to consider the benefits and the risks. Implanting surgical mesh through the vagina to treat pelvic organ prolapse is linked to higher rates of mesh-related problems. These problems include mesh poking through the vaginal wall, pelvic pain, and pain during sex. If you have received this type of surgical procedure, it’s important to follow up with routine medical care.
When transvaginal mesh implants are used for stress urinary incontinence or for prolapse repairs, there is a small chance that other problems may occur. You may experience mesh exposure erosion where the mesh may stick out through the surgical cut and into the vaginal canal. Most women with erosion do not have any symptoms. Women who do get symptoms commonly report a discharge, spotting, or discomfort during sex.
When women have problems related to transvaginal mesh implants, surgery is often required to remove the implants or portions of the implants. In some cases, surgical procedures to remove the implants can be painful, if not impossible, because the mesh has adhered to the body.
What Companies Have Been Sued for Transvaginal Mesh Products?
To date, more than 65,000 people in the United States have filed a transvaginal mesh lawsuit against the manufacturer of the product that caused their complications and injuries. While some companies, like American Medical Systems, have reached settlement agreements with the women injured by their products, other companies are continuing to fight.
In 2013, Johnson & Johnson lost a lawsuit filed by a female patient who was forced to undergo 18 surgeries after receiving the company’s Prolift vaginal implant. The female plaintiff won her case and was issued $11.11 million for her pain and suffering. In recent years, Johnson & Johnson lost another case when a jury awarded the female injury victim $5.7 million for damages.
In addition to American Medical Systems and Johnson and Johnson, other manufacturers of mesh implants have also been hit with a transvaginal mesh lawsuit that resulted in big awards to injury victims. These companies include Boston Scientific Pinnacle, C.R. Bard, Coloplast, Ethicon (a subsidiary of Johnson & Johnson), and Prolift.
In most of these lawsuits, there was serious evidence that the transvaginal mesh devices were under-tested for safety. There was no data on long-term usage and thousands of women suffered complications, even after the mesh implants were removed. Some women were not able to remove their implants, even after multiple surgeries were performed. Other women experienced mesh erosion within their bodies within 12 months after the surgical procedure was completed.
In most lawsuits filed against the manufacturers shown above, the average verdict amount the jury awarded for injuries ranged from $1.2 million to $6.7 million, but in some cases the verdict amount was considerably higher.
During the 1990s, the U.S. Food and Drug Administration (FDA) gave its first approval for the use of transvaginal mesh implants in patients. This was followed by more than 500,000 surgeries each year to address pelvic organ prolapse (POP) conditions in women. However, despite doctors embracing these transvaginal mesh products to replace older surgical products, more than 4,000 complaints of patient complications and injuries were filed with the FDA.
The first transvaginal mesh to be recalled was ProtoGen Mesh, manufactured by Boston Scientific. After FDA reports of numerous injuries to women, this device was recalled in 1999. Following this recall, the FDA issued recalls for Mentor Corporation’s OBTape and four of Johnson & Johnson’s mesh products including the Gynecare Prolift Kit, the Gynecare Prolift + M Kit, the Gynecare TVT Secure, and the Gynecare Prosima Pelvic Floor Repair System Kit.
In 2008, the FDA announced that women who use surgical mesh products are at greater risk for complications and injuries. In 2011, the FDA issued a safety communication that detailed how thousands of women reported serious complications from using transvaginal mesh products. This FDA announcement was followed by an increase in transvaginal mesh injuries, as well as transvaginal mesh lawsuits around the country.
In recent years, the FDA halted sales of surgical mesh devices used for transvaginal repair of pelvic organ prolapse (POP). Over the last decade, the FDA has issued public safety notices, convened advisory committees, and even ordered manufacturers to stop selling surgical mesh for certain transvaginal repairs after reclassifying these medical devices as “high-risk.”
In 2019, the FDA banned transvaginal mesh for treating pelvic organ prolapse (POP). In 2022, the FDA reaffirmed that using the transvaginal placement of surgical mesh to treat POP does not outweigh the risks of serious complications and injuries. To date, more than 100,000 women have filed transvaginal mesh lawsuits against the manufacturers after experiencing serious complications including internal bleeding and infections, organ perforations, and mesh erosion inside their bodies.
How to File a Transvaginal Mesh Lawsuit
Despite FDA recalls and the many medical issues and injuries caused by transvaginal mesh products, doctors continue to prescribe them for their patients, even today. Over the last decade, patient injuries caused by transvaginal mesh implants, as well as the number of patients filing for damages, have continued to rise. If you are one of those patients who suffered health complications or were injured by a defective product like a transvaginal mesh implant, it’s important to understand how to file a transvaginal mesh lawsuit to recover damages.
Defective medical devices can cause serious damage to patients such as long-term health problems, permanent injuries, temporary or permanent disabilities, and even death. The FDA can issue a recall of products to address concerns with medical devices that violate FDA laws, however, it’s the manufacturer’s responsibility to either make corrections to the product or remove it from the market to prevent more injuries.
If an implanted device like transvaginal mesh is recalled by the FDA, it may be difficult or impossible to remove it without patient harm. In such cases, manufacturers often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.
Vaginal mesh lawsuits accuse companies of a variety of misconduct actions, including negligence, warranty breaches, design and manufacturing defects, and deceptive marketing for how surgical meshes were promoted to the public. While some lawsuits proceed to a jury trial in civil court, others are settled outside a courtroom, usually between the product manufacturer (the defendant) and the injury victim (the plaintiff). Lawyers for both sides are responsible for communications in court, and communications to reach settlement agreements.
When you file a personal injury lawsuit for transvaginal mesh complications or injuries, who you sue depends on who manufactured the defective device. In some cases, doctors may also face liability for injuries through medical malpractice lawsuits.
In 2019, a woman filed a lawsuit against Ethicon, the device manufacturer, as well as her medical doctor after she experienced problems with a vaginal mesh device known as a suburethral sling (also called a TVT-O sling). Ethicon was accused of negligence for selling defective devices and failing to warn of the safety risks. The doctor was accused of failing to timely diagnose patient compilations and misrepresenting the terms of the patient’s revision surgery.
If you received a transvaginal mesh implant and you experience health complications or injuries, your device may be defective. Talk to a personal injury lawyer about filing a transvaginal mesh lawsuit to recover damages. Your lawyer can explain the legal process, gather necessary medical evidence to support your lawsuit, and guide you through preparations for a jury trial or a settlement process. You will have the opportunity to ask questions about legal procedures, filing time frames, and compensation awarded in similar cases.
You may also have the opportunity to join a class action lawsuit, a type of lawsuit that applies when multiple defendants suffer injuries from a common defendant. Both private lawsuits and class action lawsuits have advantages and disadvantages, so it’s important to discuss the pros and cons of each type with your lawyer. In most cases, private lawsuits and settlements offer substantially higher damage awards to injury victims, because class actions awards are divided among all claimants.