Women who were injured by internal bra surgery using SurgiMend Breast Mesh may be able to file a lawsuit.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting SurgiMend injury cases in all 50 states. If you or somebody you know was injured by breast mesh or internal bra surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Internal Bra Mesh Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is SurgiMend?
SurgiMend is a surgical mesh product for plastic and reconstructive surgeries. It is approved to reinforce soft tissues where weakness exists, or to repair damaged or ruptured soft tissue membranes.
What is the Risk?
SurgiMend is NOT approved for any type of breast surgery. The use of breast mesh has been linked to serious risks, including:
- Severe infection
- Disfigurement
- Abnormal breast shape
- Nerve damage
- Scarring
- Loss of sensation (numbness)
- Pain
- Additional surgeries
- And more
Who Makes SurgiMend Mesh?
SurgiMend is manufactured by Integra LifeSciences Holdings Corp., The company has been advertising SurgiMend for breast reconstruction in Europe since 2017.
What Type of Mesh is SurgiMend?
SurgiMend is a type of mesh called an Acellular Dermal Matrix (ADM). SurgiMend is manufactured from fetal/neonatal cow skin that has been processed to remove the cells, leaving behind a scaffold of natural collagen.
Is SurgiMend Permanent?
Yes. SurgiMend is a permanent implant, unlike some other types of surgical mesh that are designed to dissolve over time.
SurgiMend is NOT absorbed by the body. Instead, it is a permanent implant that is designed to trigger inflammation in the body. The inflammation results in scar-tissue growth around the SurgiMend scaffold, which is supposed to help reinforce or repair soft tissues.
Is SurgiMend Approved for Breast Surgery?
No. In the U.S., there are no surgical mesh products that have been approved or evaluated by the FDA for any type of breast surgery. Even so, SurgiMend has been used “off-label” for breast surgeries for more than a decade.
SurgiMend Was Originally Used for Hernia Repairs
SurgiMend is one of many types of surgical mesh products that were originally designed and approved for hernia repairs.
Like these other products, SurgiMend is now commonly used in breast surgeries like the “Internal Bra,” breast lifts, augmentations, and implant-based breast reconstruction for women who have survived breast cancer.
FDA Warning for SurgiMend Risks in Breast Surgery
In March 2021, the FDA published a Safety Warning about serious complications from certain types of ADM mesh in breast surgery, including infections, explantation (implant removal) and re-operation (needing surgery).
FDA Refuses to Approve SurgiMend for Breast Surgery
In October 2021, the FDA held an Advisory Committee Meeting to discuss a possible expanded approval for SurgiMend to include soft-tissue support in post-mastectomy breast reconstruction.
The FDA rejected approval for SurgiMend for breast reconstruction, based on data including the MDOC Study, which found that patients who received SurgiMend had higher rates of major complications like wound infections requiring antibiotics, and revision surgeries.
Thousands of Mesh Injury Lawsuits Have Been Filed
Thousands of lawsuits have been filed by people who were injured by surgical mesh products, including hernia mesh and vaginal mesh. The manufacturers are well-aware of the risks, and yet many breast mesh products are being advertised and used in “off-label” breast surgeries.
What Do Lawsuits Claim?
Lawsuits can be filed by people who were injured by defective medical devices. These lawsuits typically accuse manufacturers of negligence for failing to adequately warn patients about the risk of complications.
How Can a Lawsuit Help?
If you were injured by SurgiMend breast mesh that was used during your breast surgery, you may be eligible to file a lawsuit.
Our lawyers may be able to help you seek justice and compensation for your pain and suffering, medical expenses, long-term injuries (i.e., chronic pain, disfigurement, etc.), decreased quality of life, and other damages.
Do I Have a SurgiMend Lawsuit?
The Schmidt Firm, PLLC is currently accepting SurgiMend injury cases in all 50 states. If you or somebody you know was injured by breast mesh or internal bra surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Internal Bra Mesh Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.
The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.
