Boston Scientific and Vaginal Mesh Implants

Boston Scientific Corporation is a well-known medical device company that has been in operation for several decades.

Boston Scientific was founded in 1979 and is headquartered in Marlborough, Massachusetts.

The company specializes in developing and manufacturing a wide range of medical devices and products, including cardiovascular machines, endoscopy equipment, and surgical mesh devices.

Boston Scientific Corp. entered the market for vaginal mesh implants to provide a solution for women suffering from pelvic organ prolapse (POP) and stress urinary incontinence (SUI). 

Pelvic organ prolapse (POP) is a condition where pelvic organs, such as the bladder, uterus, or rectum, sag into the vaginal wall.

Stress urinary incontinence (SUI) is characterized by the involuntary leakage of urine during physical activities that put pressure on the bladder, such as coughing, sneezing, laughing, or exercising.

Boston Scientific introduced a range of transvaginal mesh implants to address these issues.

Boston Scientific Corp. was a pioneer in the market for vaginal mesh implants with Protegen.

This product was the company’s first vaginal sling device, approved by the U.S. Food and Drug Administration (FDA) in 1996.

Protegen became the basis for many other brands of transvaginal mesh products, including Johnson & Johnson and C.R. Bard.

Major manufacturers modeled their products after Boston Scientific’s Protegen and used its approval to obtain 501(k) clearance from the FDA.

The 501(k) clearance process allows manufacturers to bypass comprehensive clinical trials for new products if their products are substantially similar to approved existing ones.

This shortcut has been a subject of criticism as it may not fully evaluate the safety and effectiveness of devices.

Vaginal mesh implants, including those Boston Scientific manufactured, were designed to provide structural support to the pelvic organs and alleviate the distressing symptoms of POP and SUI that many women experienced.

The implantation of these devices was done through transvaginal mesh surgery, which is considered minimally invasive compared to traditional surgery.

Women were promised improved quality of life and relief from their discomfort.

However, the road ahead would be far more problematic than expected.

Vaginal mesh has been increasingly linked to a range of serious injuries and complications.

Many patients have reported severe issues post-implantation, including chronic pain, mesh erosion, infection, and organ perforation.

These complications often require additional medical interventions and have led to a significant number of lawsuits against manufacturers, highlighting the risks associated with the use of vaginal mesh in medical treatments.

Boston Scientific Vaginal Mesh Products

Boston Scientific released several distinct transvaginal mesh products to treat POP and SUI.

These products were intended to offer relief to women suffering from these conditions.

Here are some of the vaginal mesh devices Boston Scientific manufactured:

• Pinnacle Pelvic Floor Repair Kit: The Pinnacle kit was designed to repair pelvic organ prolapse. It included synthetic mesh materials and instruments for implantation.
• Advantage Transvaginal Mid-Urethral Sling System: This system was used to treat stress urinary incontinence. It involved placing a mesh sling to support the urethra and reduce leakage.
• Advantage Fit Transvaginal Mid-Urethral Sling System: This product was designed to treat stress urinary incontinence (SUI) in women. It aimed to provide additional support to the urethra.
• Obtryx Sling System: The Obtryx Sling System was intended for the surgical treatment of stress urinary incontinence in women. It typically involved placing a sling made of synthetic mesh to support the urethra.
• Obtryx Transobturator Mid-Urethral Sling: Similar to the Obtryx Sling System, this product was used to treat stress urinary incontinence by placing a mesh sling via a different approach (transobturator).
• Lynx Suprapubic Mid-Urethral Sling System: This system was designed to treat stress urinary incontinence in women, using a suprapubic approach for sling placement.
• Prefyx PPS System: The Prefyx system was used to treat pelvic organ prolapse. It involved the use of synthetic mesh for support.
• Arise Vaginal Support System: This product was designed for the treatment of pelvic organ prolapse in women. It utilized synthetic mesh for support.
• Polyform Synthetic Mesh: Polyform mesh products were used for various pelvic floor repair procedures, including treating pelvic organ prolapse and urinary incontinence.
• Uphold Vaginal Support System: The Uphold system was designed to treat pelvic organ prolapse in women. It involved the use of synthetic mesh to provide support to weakened pelvic structures.

These are just some of the many Boston Scientific products marketed for repairing and treating POP and SUI in women.

However, instead of improved quality of life, many women experienced devastating and sometimes permanent complications due to these products.

Transvaginal Mesh Complications and Injuries

While the intentions behind these products were noble, many women who received these transvaginal mesh implants experienced serious complications and injuries.

These adverse effects have not only impacted their physical health but also significantly affected their emotional wellbeing and quality of life.

The widespread nature of these issues has led to a reevaluation of the safety and efficacy of transvaginal mesh products, culminating in legal actions and increased regulatory scrutiny.

Transvaginal mesh complications and injuries include:

• Mesh erosion
• Mesh infection
• Severe pain and discomfort
• Organ perforation
• Vaginal scarring
• Vaginal bleeding
• Dyspareunia
• Urinary Problems
• Psychological and Social Impacts

Mesh Erosion

One of the most common issues associated with vaginal mesh implants is mesh erosion.

This complication occurs when the mesh material starts to break down and erode into surrounding tissues, causing pain, discomfort, and infection.

It can occur in various pelvic areas, such as the vagina, bladder, or rectum.

Mesh Infection

Another serious complication is mesh infection.

The synthetic mesh used in these devices can harbor bacteria and other foreign bodies and cause severe conditions that are difficult to treat.

These issues can lead to chronic pain, recurrent urinary tract infections, and even sepsis in some cases.

Severe Pain and Discomfort

Many women reported experiencing intense and chronic pain and discomfort after receiving vaginal mesh implants.

This pain can be debilitating and significantly impact their quality of life.

In some cases, this pain often required additional surgeries to address.

Organ Perforation

Organ perforation is another potential complication of transvaginal mesh surgery.

This problem can occur when the sharp edges of the mesh puncture or damage nearby organs, such as the bladder or intestines, leading to serious health complications.

Patients with organ perforation often require emergency medical attention and additional surgeries to repair the damage.

Vaginal Scarring

Some women who received vaginal mesh implants also experienced excessive scarring in their pelvic area.

This issue can cause discomfort, pain, and reduced mobility for these women.

In some cases, the scarring can also cause sexual dysfunction and decreased sexual satisfaction.

Vaginal Bleeding

Some women have reported experiencing vaginal bleeding after receiving transvaginal mesh implants.

This issue can be caused by the mesh rubbing against delicate tissues in the pelvic area, leading to irritation and bleeding.

In severe cases, the bleeding may require medical intervention.

Dyspareunia

Dyspareunia, or pain during sexual intercourse, is another common issue women who received vaginal mesh implants reported.

This complication can result from nerve damage due to the mesh or other problems related to the implantation procedure.

Dyspareunia can significantly impact a woman’s sexual health and intimacy.

Urinary Problems

Many women have experienced urinary problems after receiving vaginal mesh implants.

Women have reported difficulty urinating, recurrent urinary tract infections, and leakage due to the mesh’s placement near the bladder and urethra.

These types of conditions can be both physically and emotionally distressing for affected women.

Psychological and Social Impact

In addition to these physical complications, many women also experienced psychological and social effects from receiving transvaginal mesh implants.

These issues include anxiety, depression, decreased self-esteem and body image, and strained relationships due to the physical and emotional toll of their condition.

This pain and suffering can be long-lasting and significantly impact a woman’s overall well-being.

The complications and injuries associated with transvaginal mesh implants have had a devastating impact on the lives of many women.

The Broader Landscape of Transvaginal Mesh Lawsuits

The vaginal mesh lawsuit landscape has been a lengthy and complex legal battle.

Thousands of victims have filed transvaginal mesh lawsuits against various manufacturers of transvaginal mesh devices, including Boston Scientific.

These lawsuits typically claim that the manufacturers failed to adequately warn patients and healthcare providers about the risks associated with these products and negligently produced and marketed these devices.

Many of these lawsuits were consolidated into multidistrict litigation (MDL) cases to streamline the litigation process.

The United States Judicial Panel on Multidistrict Litigation (JPML) played a pivotal role in this consolidation.

An MDL allows multiple similar cases to be managed efficiently, preserving time and resources for all parties involved.

There was a transvaginal mesh MDL for seven major manufacturers of these devices, including Boston Scientific Corp.

These combined MDLs involved over 100,000 individual transvaginal mesh lawsuits, highlighting the widespread impact of these products on women’s health.

This large-scale lawsuit became one of the largest and most complex mass tort litigations in United States history.

Most transvaginal mesh MDLs and lawsuits, including those against Boston Scientific, have been resolved in previous years.

Judge Joseph Goodwin of the U.S. District Court for the Southern District of West Virginia presided over the most recent transvaginal mesh MDL.

In November 2022, Judge Goodwin concluded the MDL and returned the remanded cases to their original state courts for further litigation or resolution.

The settlements have provided some compensation to women who suffered from the complications and injuries associated with these devices.

Victims of transvaginal mesh implants may still file new cases and claims in state courts.

Those who believe they have been affected by transvaginal mesh implants should consult with an experienced transvaginal mesh lawyer to understand their legal options.

Boston Scientific's Litigation History

Boston Scientific Corp.’s involvement in the vaginal mesh lawsuit has been particularly notable.

The company faced many cases related to its transvaginal mesh products.

These lawsuits alleged that the company’s products were defective and unreasonably dangerous and that Boston Scientific failed to provide sufficient warning to patients and healthcare providers about the potential risks associated with their use.

As a result of these lawsuits, Boston Scientific has paid substantial settlements to affected women.

Here are some significant settlements the medical device manufacturer has come to:

• November 2014: A Miami jury ordered Boston Scientific to pay four women a total of $26.7 million in damages.
• November 2014: A New Jersey jury held Boston Scientific liable for injuries to four women with the Obtryx device. Each plaintiff shared $14.5 million for their damages and another $4 million in punitive damages. Boston Scientific appealed the verdict, which an appellate court later upheld in February 2018.
• April 2015: The company agreed to pay $119 million to settle almost 3,000 transvaginal mesh lawsuits.
• May 2015: A Delaware jury awarded $100 million in damages to a woman who suffered permanent injuries due to Boston Scientific’s transvaginal mesh product.
• October 2018: The corporation settled approximately 50,000 lawsuits for $189 million.
• March 2021: Boston Scientific Corp. paid $188.7 million to settle deceptive marketing claimed by 47 states and Washington, D.C.

These were some of the largest transvaginal mesh settlements to date, with the total amount Boston Scientific paid reaching hundreds of millions of dollars.

While these settlements have provided some compensation to affected women, it is essential to remember that no amount of money can undo the physical and emotional damage these devices have caused.

Many women still live with long-term effects from transvaginal mesh implants and may require ongoing medical treatment.

While many of these cases have been resolved, there are still ongoing lawsuits, and more women continue to come forward, seeking justice for the complications they have endured due to the company’s products.

The legacy of these lawsuits is a stark reminder of the importance of patient safety and thorough testing in the medical device industry.

Other Transvaginal Mesh Manufacturers Facing Lawsuits

While Boston Scientific Corp. has played a prominent role in the vaginal mesh lawsuit, it’s important to note that it is not the only company facing transvaginal mesh lawsuits.

Several other manufacturers have also been implicated in similar lawsuits.

Other manufacturers that have faced litigation over their transvaginal mesh products include:

• C.R. Bard, Inc.
• Ethicon, Inc. (a subsidiary of Johnson & Johnson)
• American Medical Systems, Inc.
• Coloplast Corp.
• Cook Medical, Inc.
• Neomedic

These manufacturers have faced similar allegations regarding the safety and efficacy of their products and the adequacy of warnings provided to patients and healthcare professionals.

The collective legal battles have underscored the need for more stringent regulation and oversight of medical device development and marketing.

TorHoerman Law: Your Transvaginal Mesh Lawyer

While the intention behind transvaginal mesh products was to provide relief to women suffering from pelvic organ prolapse and stress urinary incontinence, the outcome has been far from the promised solution.

Most MDLs and cases have been resolved, but this issue is far from over.

State courts are now handling new cases, and women are still coming forward with claims of serious complications from transvaginal mesh implants.

If you or a loved one has suffered vaginal mesh complications, an experienced transvaginal mesh lawyer can help you understand your legal options.

TorHoerman Law has a dedicated and experienced team of attorneys who can provide the support and guidance you need to pursue a transvaginal mesh lawsuit.

Contact TorHoerman Law today for a free, no-obligation consultation.

You can also use the chatbot on this page to find out if you qualify for the Boston Scientific transvaginal mesh lawsuit instantly.