DuraSorb Lawsuit

DuraSorb Breast Mesh has been linked to severe side effects when it is used in breast surgeries like the “Internal Bra.”

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting DuraSorb injury cases in all 50 states. If you or somebody you know was injured by side effects or needed surgery for problems with DuraSurb Breast Mesh or Internal Bra Mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

What is DuraSorb?

DuraSorb® Monofilament Mesh is a bio-absorbable scaffold that is used for the temporary reinforcement of soft-tissues. It is advertised to fully resorb in 12 months, after supporting natural tissue growth.

How Does DuraSorb Work?

When any foreign object is implanted in the body, including DuraSorb, the body responds with inflammation and scar-tissue growth around the object. Over time, the mesh dissolves, leaving behind a supportive structure of new tissue that is supposed to provide long-term support.

What is the Problem?

Thousands of lawsuits have already been filed by people who were injured by surgical mesh products like hernia mesh and vaginal mesh. Now, there is growing concern about the potential risks of breast mesh products.

DuraSorb Side Effects

DuraSorb has been linked to reports of serious side effects and complications, such as:

• Infection
• Chronic pain or discomfort
• Breast disfigurement
• Breast reconstruction failure
• Mesh erosion or migration
• Seroma or fluid accumulation
• Needing another surgery (revision surgery)
• And more

Safety Concerns for Breast Cancer Survivors

Breast mesh has specific safety concerns for breast cancer patients. DuraSorb and other types of mesh are being used in breast reconstruction surgeries for breast cancer survivors who had a mastectomy (surgery to remove the breast). The mesh triggers inflammation, which could be a problem for breast cancer patients.

Breast mesh can also obscure breast tissue on a mammogram. The researchers also cautioned: “The long-term implications of mesh use in breast surgery remain unclear.”

Who Created DuraSorb?

DuraSorb was originally developed by Surgical Innovation Associates Inc., a company based in Chicago that was acquired by Integra LifeSciences in December 2022.

What is DuraSorb Made Of?

DuraSorb is a synthetic absorbable mesh that is made from polydioxanone (PDO). This material was originally designed for dissolvable sutures, and it is now commonly used in “thread lifts.”

PDO has also been repurposed for surgical mesh products like DuraSorb. The threads are woven into a flexible sheet of material that acts like a scaffold for soft-tissue reconstruction surgeries.

DuraSorb Is NOT Approved for Breast Surgery

While DuraSorb is now commonly used in a variety of breast surgeries, this is an “off-label” surgery that has not been evaluated or approved by the FDA. There are currently NO surgical mesh products on the market in the U.S. that are approved for breast surgery.

What is DuraSorb Approved for?

DuraSorb was originally approved by the FDA in September 2018 for the reinforcement of soft-tissue where weakness exists. And while DuraSorb is approved in Europe for cosmetic and reconstructive breast procedures, this use is not approved in the U.S.

Studies Investigating DuraSorb for Breast Surgery

Any type of breast surgery using DuraSurb is an “off-label” surgery, which means that it has not been evaluated or approved by the FDA. However, the manufacturer of DuraSorb has been studying the risks and benefits of DuraSorb for breast surgeries.

For example, there is a clinical trial investigating the safety of DuraSorb for breast reconstruction. There have also been other early studies investigating DuraSorb for breast implant patients who needed revision surgery. However, these studies were limited by a small number of patients, so they may not provide a complete picture of the risks and benefits.

Can I Join a DuraSorb Lawsuit?

Our lawyers are evaluating cases for women who were injured by breast mesh and “Internal Bra” surgeries. You may be eligible to file a lawsuit if you:

• Had a breast reconstruction, augmentation, breast lift, or other breast surgery where mesh was used
• Experienced severe side effects or complications, such as revision surgery, pain, infection, physical disfigurement, etc.
• Have medical records of your procedure and follow-up care related to complications
• Were diagnosed with a severe side effect within the time-limit set by your state (“statute of limitations”)

How Can a Lawsuit Help?

If you are eligible to file a DuraSorb Lawsuit, we may be able to help you seek justice and compensation. Every case is unique, but a DuraSorb lawsuit will likely try to achieve a payout for the victim’s physical and emotional injuries, pain and suffering, medical expenses, lost income, long-term injuries (like disfigurement or scarring), and other losses.

Do I Have a DuraSorb Lawsuit?

The Schmidt Firm, PLLC is currently accepting DuraSorb Breast Mesh injury cases in all 50 states. If you or somebody you know was injured by Internal Bra Mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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