Did You Have Breast Surgery Involving GalaFLEX Mesh and Develop Complications?
If you underwent breast augmentation, a breast lift, or breast reconstruction involving GalaFLEX mesh and later developed serious complications, you may have legal options.
Women who received GalaFLEX as an internal support during breast surgery have reported complications involving infection, pain, fluid buildup, mesh movement, nerve symptoms, implant loss, and the need for additional surgery.
You may be eligible to pursue compensation through a GalaFLEX breast mesh lawsuit.
Contact the nationwide breast mesh lawsuit attorneys at Anapol Weiss for a free and confidential case evaluation. Call 215-735-1130 or contact us online today.
What Is GalaFLEX Breast Mesh?
GalaFLEX is a bioabsorbable surgical scaffold designed to reinforce weakened soft tissue. GalaFLEX products have been cleared by the U.S. Food and Drug Administration (FDA) for soft-tissue repair and reinforcement.
However, surgical mesh has also been used by plastic surgeons during breast procedures as an internal support or “internal bra.” The mesh may be placed inside the breast to support implants or reinforce breast tissue during procedures such as:
- Breast augmentation
- Breast lifts, also known as mastopexy
- Breast reconstruction following a mastectomy
- Breast implant revision procedures
The FDA has stated that no surgical mesh products are cleared or approved for use in breast surgery and that the safety and effectiveness of surgical mesh for breast augmentation or reconstruction have not been determined by the agency.
In November 2023, the FDA issued a communication to healthcare providers concerning updated labeling for several Becton, Dickinson and Company (BD) mesh products, including GalaFLEX Scaffold and GalaFLEX Lite Scaffold. The FDA advised healthcare providers to review the updated warnings and precautions associated with these products.
For some women who underwent breast procedures involving GalaFLEX, serious complications have followed.
What Complications Have Been Linked to GalaFLEX Breast Mesh?
Women who received GalaFLEX during breast surgery may experience complications such as:
- Chronic infections that do not resolve with antibiotics
- Pain or painful hardening of breast tissue
- Recurring fluid buildup, sometimes referred to as seroma
- Mesh shifting or detaching from its intended position
- Mesh erosion through surrounding tissue or skin
- Burning, numbness, or other symptoms associated with nerve damage
- Persistent inflammation or discomfort
- Implant loss
- Failure of a breast reconstruction
- The need for revision surgery or mesh removal
Complications do not necessarily appear immediately after surgery. Some women may initially recover without significant problems before symptoms become apparent months or even years later.
If you have experienced unexpected complications after a breast augmentation, lift, reconstruction, or revision procedure, determining whether GalaFLEX or another type of breast mesh was used can be an important first step.
Learn More From Our Women's Health Litigation Team
Anapol Weiss has a dedicated Women's Health Litigation Team representing women harmed by potentially unsafe medications, medical devices, medical negligence, and other products and procedures affecting women's health.
Our attorneys are currently investigating claims involving surgical mesh used in breast procedures nationwide.
Call 215-735-1130 for a free, confidential case evaluation.
Who May Be Eligible to File a GalaFLEX Lawsuit?
Every potential claim must be evaluated individually. You may want to speak with a GalaFLEX breast mesh lawsuit attorney if one of the following situations applies to you.
You Had Breast Augmentation or a Breast Lift Involving GalaFLEX
You underwent breast augmentation or a breast lift in which GalaFLEX was used as an internal support and later developed complications such as infection, fluid buildup, mesh migration or erosion, implant loss, chronic pain, or nerve symptoms.
You Had Post-Mastectomy Breast Reconstruction Involving GalaFLEX
You underwent breast reconstruction following a mastectomy in which GalaFLEX was implanted and subsequently experienced significant complications, implant problems, or reconstruction failure.
You Needed Revision Surgery Because of GalaFLEX Complications
You underwent an additional operation to address complications associated with GalaFLEX mesh, including mesh removal, repair, implant replacement, or another revision procedure.
The date of the original surgery does not necessarily determine whether you have a potential claim. Legal deadlines vary depending on the circumstances and the state whose law applies, so anyone experiencing possible GalaFLEX complications should speak with an attorney promptly.
What Should I Do if I Think GalaFLEX Was Used During My Breast Surgery?
You may not remember the name of every product used during your procedure. In some cases, patients may simply have been told that their surgeon would use an “internal bra,” mesh, scaffold, or another form of surgical support.
Your medical records may help identify whether GalaFLEX was implanted.
Documents that may be particularly helpful include:
- Operative reports
- Implant or device records
- Surgical consent forms
- Hospital or surgical-center records
- Plastic surgeon records
- Records from follow-up appointments
- Records relating to infections or other complications
- Records from revision or mesh-removal surgery
You do not need to have every document before contacting Anapol Weiss. Our legal team can discuss what you know about your procedure and help determine what additional information may be needed to evaluate a potential GalaFLEX lawsuit.
GalaFLEX Lawsuits and Breast Mesh Litigation
Potential GalaFLEX lawsuits are part of a broader developing area of litigation involving surgical mesh used during breast procedures.
Anapol Weiss is actively investigating breast mesh claims involving women who experienced complications after augmentation, reconstruction, breast lifts, and other procedures involving surgical mesh or internal-bra products.
Depending on the circumstances, a claim may involve allegations concerning the design, testing, warnings, marketing, or use of a medical device. Each case is different, and the existence of a complication does not automatically establish that a manufacturer, healthcare provider, or another party is legally responsible.
Our attorneys investigate each potential claim individually to determine what happened, what product was used, how the patient was injured, and whether there may be grounds to pursue compensation.
What Compensation May Be Available in a GalaFLEX Breast Mesh Lawsuit?
A woman who has been injured after a breast procedure involving GalaFLEX may be able to pursue compensation for legally recognized losses associated with her injuries.
Depending on the circumstances, those losses may include:
- Medical expenses
- Costs of revision or mesh-removal surgery
- Future medical treatment
- Lost wages
- Reduced earning capacity
- Pain and suffering
- Other economic and non-economic damages
The compensation available in any particular GalaFLEX lawsuit depends on the facts of the case, the extent of the injuries, and the law that applies.
A Nationally Recognized Team of Women Advocating for Women
The Women's Health Litigation Team at Anapol Weiss is led by a nationally recognized group of female attorneys with a track record of pursuing significant verdicts and settlements for women harmed by medical negligence, unsafe medications, defective medical devices, and health and wellness products.
Women facing legal challenges involving injuries to their bodies may feel more comfortable discussing deeply personal medical experiences with female attorneys who understand the sensitive nature of these claims.
Anapol Weiss has substantial experience handling complex litigation involving women's health and surgical mesh. The firm's attorneys have represented women in medical device and product liability litigation and continue to investigate emerging claims involving breast mesh products nationwide.
Speak With a GalaFLEX Breast Mesh Lawsuit Attorney Today
If you believe you may have been harmed by GalaFLEX during breast augmentation, reconstruction, a breast lift, or another breast procedure, you do not have to determine on your own whether you have a potential case.
Anapol Weiss can review the circumstances surrounding your surgery, your symptoms, and the medical treatment you have required to determine whether you may have legal options.
Your initial consultation is free and confidential.
Call Anapol Weiss at 215-735-1130 or contact us online today to request your free case evaluation.