Boston Scientific Transvaginal Mesh Lawsuit: What You Need to Know

Ketterer, Browne & Davini, LLC is currently representing a plaintiff in a lawsuit against Boston Scientific regarding serious injuries from the Boston Scientific Obtryx II Halo SGL transvaginal mesh (TVM) implant. This case highlights the risks of certain medical devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women, and the ongoing efforts of our firm to hold manufacturers accountable for defective products.

What Happened to the Plaintiff

The plaintiff underwent surgery on or about January 23, 2020, during which the Boston Scientific Obtryx II Halo SGL mesh was implanted at Providence Medford Medical Center in Medford, Oregon.

After the implant, the plaintiff suffered serious complications, including:

• Infection and abscesses

• Severe pelvic pain and cramping

• Bleeding, purulence, and necrotic tissue

• Recurrence of the condition

• Surgical removal and debridement of necrotic tissue

In November 2024, the plaintiff required revision surgery, also at Providence Medford Medical Center. Despite these efforts, the plaintiff continues to face chronic pain, physical limitations, emotional distress, and the possibility of additional surgeries in the future.

Why This Case Matters: TVM Risks

Transvaginal mesh (TVM) has been widely used to treat pelvic organ prolapse and stress urinary incontinence. While these devices were intended to provide support to weakened pelvic tissues, research and patient reports have revealed that some TVM products can be defective and dangerous.

As explained in the complaint:

• TVM mesh can contract, shrink, or migrate within the body.

• Inelasticity of the mesh can damage sensitive pelvic tissues, causing pain during daily activities, intercourse, and other normal functions.

• Mesh erosion or extrusion is common, often requiring complex surgical removal, which can be incomplete or impossible.

• The polypropylene material used in many meshes can trigger chronic immune and inflammatory responses, resulting in permanent injury.

• Patients may suffer from urinary dysfunction, dyspareunia (painful sex), nerve damage, and organ prolapse due to the mesh.

These risks were not adequately disclosed to patients or physicians, leaving women vulnerable to life-altering injuries.

Claims Against Boston Scientific

The lawsuit KBD has filed includes multiple legal claims, reflecting the serious nature of the plaintiff’s injuries:

1. Product Liability – Failure to Warn

Our firm believes Boston Scientific has failed to warn patients and healthcare providers about:

• High rates of infection, chronic pain, and mesh erosion

• The difficulty or impossibility of complete mesh removal

• Need for multiple surgeries

• Safer alternative treatments available

Because of these omissions, the mesh is considered unreasonably dangerous, making Boston Scientific strictly liable for the plaintiff’s injuries.

2. Strict Product Liability – Defective Design

We also believe that the mesh was defectively designed, causing:

• Chronic inflammatory responses

• Migration and erosion of mesh

• Non-anatomic conditions in the pelvis leading to permanent pain and disability

• Use of arms and anchors that can injure major nerves

Despite post-market reports and scientific research highlighting these risks, Boston Scientific failed to monitor or act on adverse events, violating FDA Medical Device Reporting regulations.

3. Breach of Implied Warranty of Merchantability

The plaintiff alleges that Boston Scientific represented the mesh as safe and effective for its intended use. However, the mesh failed to meet these standards, making it unfit for ordinary use.

4. Negligence

The complaint claims Boston Scientific failed to exercise reasonable care in designing, testing, manufacturing, marketing, labeling, and selling the mesh. Negligence contributed to the mesh being unreasonably dangerous and led directly to the plaintiff’s injuries.

5. Negligent Misrepresentation

Boston Scientific allegedly misrepresented the safety of the mesh to physicians, the medical community, and patients. The company marketed the mesh as “trusted” and suitable for preferred surgical approaches, despite knowing it was inadequately tested and potentially unsafe.

Why Patients Need Legal Support

Women injured by TVM implants face a range of physical, emotional, and financial challenges:

• Chronic pain and functional disability

• Repeated surgeries, often with limited success

• Mental anguish, embarrassment, and decreased quality of life

• Substantial medical bills and lost income

At Ketterer, Browne & Davini, LLC, we understand the complexities of TVM cases. Our team works to hold medical device manufacturers accountable, helping patients pursue compensation for medical costs, pain and suffering, and economic losses.

Long History of Boston Scientific Problems

Boston Scientific has a long history of medical device litigation, particularly involving products marketed to women. In the past, the company faced widespread lawsuits over its transvaginal mesh implants,Defibrillator Lead,  Accolade Pacemaker Recall, Cryoablation Balloons, PolarX Recall and PolarX FIT Recall etc. At Ketterer, Browne & Davini, LLC, we are proud to represent this, as she has suffered at the hands of Bsoton Scientific. Her story is just one example of the risks that can come from this product. They are not just historical but ongoing. This case demonstrates how defective design, inadequate warnings, and corporate negligence can leave patients with permanent injuries—reminding us that vigilance and accountability are still urgently needed when it comes to medical device safety.

Our Commitment to Medical Device Safety

TVM lawsuits highlight broader concerns about medical device regulation and patient safety. Manufacturers have a responsibility to:

• Conduct thorough testing before and after release

• Warn patients and doctors about known risks

• Monitor adverse events and comply with FDA reporting requirements

When companies fail in these duties, patients should not bear the consequences alone. Our firm has extensive experience representing victims of defective medical devices, including TVM mesh, hip implants, surgical devices, and more.

Conclusion

The Boston Scientific TVM case demonstrates the serious risks associated with transvaginal mesh implants and the critical need for accountability in medical device manufacturing. Women who have experienced complications after receiving pelvic mesh implants may be entitled to compensation for medical expenses, pain and suffering, and lost quality of life.

Ketterer, Browne & Davini, LLC is committed to protecting patients’ rights and ensuring that medical device manufacturers face consequences for defective and dangerous products. If you or a loved one has suffered injuries from TVM or other medical devices, our team can provide experienced legal guidance and support. Contact us today for help.