Internal Bra Mesh Attorneys
Internal bra mesh is a surgical material used in breast augmentation, reconstruction, and lift procedures to provide additional support, reinforce tissue, and help maintain shape as the body heals. However, some patients have reported complications such as pain, infection, implant issues, and poor healing. Many also say they were not clearly informed that this type of material would be implanted.
FREE CASE REVIEW
If you experienced complications after a procedure involving internal bra mesh, Farah & Farah’s defective medical device attorneys can help you take the next step. Our team can evaluate your situation, explain your legal options, and determine whether you may be eligible to pursue compensation for medical expenses, additional surgeries, and the impact on your quality of life. You deserve to have someone standing on your side, and that’s exactly what we’re here to do.
What Is Internal Bra Mesh?
Internal bra mesh is a type of implanted material used to reinforce breast tissue during certain surgical procedures like breast augmentation, reconstruction, or lifts. Instead of relying on existing breast tissue alone, surgeons may opt to use internal bra mesh to provide additional support where the breast structure is weak, stretched, or needs reinforcement. Internal bra mesh is also called surgical mesh and technically hasn’t been approved by the FDA for use in breast surgeries, although it often is.
What Is Internal Bra Mesh Made of?
Internal bra materials generally fall into three categories:
- Synthetic mesh
- Bioresorbable scaffolds, which gradually dissolve
- Biologic ADM (acellular dermal matrix), which is made of processed human or animal material
Internal bra mesh is most typically used in more complex cases, such as a reconstruction surgery following a mastectomy, a revision surgery, or any procedure in which the breast tissue is thinner or weaker.
Why Are People Filing Internal Bra Mesh Lawsuits?
For some women, recovery from their breast procedure didn’t go as expected. Instead of improving over time, they instead experienced infection, chronic pain, wounds that didn’t heal, or other issues with their implants that required additional treatment. With more and more patients reporting similar problems, legal claims have begun to be filed against the internal bra mesh manufacturers.
Those who have filed lawsuits claim that the manufacturers didn’t adequately warn of the risks and whether these products were promoted for use in breast surgery despite the lack of FDA clearance or approval for that purpose.
What Does the FDA Say About Internal Bra Mesh?
Although certain surgical mesh products have been cleared by the FDA for use in repairing and reinforcing weakened soft tissue, the FDA cannot determine the safety or effectiveness of those products when used in breast surgeries. In 2023, the FDA issued a letter to healthcare professionals to inform them that surgical mesh had not been cleared for use in breast surgeries. This means that any use of surgical mesh in breast reconstruction or augmentation is technically an “off-label” use.
What Does "Off-Label" Use Mean?
“Off-label” use means a doctor uses a medical product in a way that is not included in its FDA-cleared or approved labeling. Doctors are allowed to use devices off-label when they believe it is appropriate for a patient. Manufacturers generally aren’t allowed to market or otherwise promote uses for their products that haven’t been cleared or approved by the FDA. In the lawsuits against internal bra mesh manufacturers that have been filed, one of the claims is that manufacturers promoted their surgical mesh for use in breast surgeries anyway.
Who Manufactures Internal Bra Mesh?
In many cases, the patient doesn’t actually know which company manufactured the mesh used in their surgery. In some cases, the patient wasn’t aware that internal bra mesh was used at all. It may show up in the hospital records as simply mesh, scaffolding, or matrix
The companies that most commonly manufacture the surgical mesh used as internal bra mesh are:
BD Products (Phasix and GalaFLEX)
BD (Becton, Dickinson and Company) manufactures products such as Phasix and GalaFLEX, which are often used for soft tissue reinforcement. In medical records, these materials may be described more generally as mesh, scaffold, or internal support material.
Integra LifeSciences and DuraSorb
Integra LifeSciences produces DuraSorb, a monofilament mesh designed for soft tissue support. It may be used in procedures where additional internal reinforcement is needed.
Biologic ADM Products in Reconstruction
Biologic ADM (acellular dermal matrix) products are made from processed human or animal tissue and are commonly used in breast reconstruction. These materials are often described as a matrix or dermal graft and are used to provide structural support.
$2+ BILLION IN RESULTS
What Complications Are Linked to Internal Bra Mesh?
When a breast surgery goes well, recovery can be uncomfortable at first, but improvement occurs week by week following the surgery. When the use of internal bra mesh causes complications, however, that improvement may not occur, leaving patients with infections, wounds that don’t heal, and other health problems.
Infection
Infection is one of the most urgent complications because it can progress quickly. Treatment may include oral antibiotics, IV antibiotics, drainage, wound care, and sometimes hospitalization. In some situations, doctors may recommend removing an implant to control the infection. The FDA notes that infections can occur after breast implant surgery and that removal may be necessary if an infection does not respond to antibiotics.
Common warning signs include:
- Redness, warmth, or swelling that increases instead of improving
- Drainage from the incision, including a foul odor
- Fever or chills
- Severe pain that worsens rather than settles down
- Sudden firmness or swelling in the breast
- Feeling unusually weak or sick
Skin Necrosis (Tissue Death)
Skin necrosis occurs when tissue does not receive enough blood supply and begins to die. This can delay healing, increase the risk of infection, and lead to additional procedures to remove damaged tissue or support recovery. The FDA lists necrosis as a potential complication following breast implant procedures.
Common warning signs include:
- Darkened or blackened areas of skin
- Wounds that do not close or continue to break down
- Skin that appears thin, dry, or leathery
- Open sores or areas of tissue loss
- Increased pain around a non-healing area
Implant Failure or Reconstruction Breakdown
Implant failure or reconstruction breakdown can occur when the surgical site does not heal properly or complications make it difficult to maintain the implant. This may lead to additional procedures, including implant removal or revision surgery. In some cases, ongoing drainage, infection, or tissue damage contributes to the breakdown.
Common warning signs include:
- Persistent drainage or fluid buildup (seroma)
- Implant shifting, dropping, or feeling unstable
- Delayed or incomplete healing
- Reopening of the surgical site
- Recommendation from a doctor to remove or replace the implant
Breast Deformity
Breast deformity can develop when healing does not occur as expected or when structural support within the breast is compromised. This may affect appearance, symmetry, and overall results, sometimes worsening over time rather than improving.
Common warning signs include:
- Noticeable asymmetry between breasts
- Sagging or “bottoming out”
- Implant malposition or visible shifting
- Changes in shape when standing or moving
- Distortion that was not present immediately after surgery
Chronic Pain
Pain is expected during the early healing period after breast surgery. What these investigations focus on is pain that continues, worsens, or interferes with daily life well beyond normal recovery. Chronic pain may involve inflammation, tight scar tissue, nerve irritation, or ongoing healing problems. The FDA lists breast pain among reported implant complications.
Chronic pain may be described as:
- Deep aching, burning, or sharp pulling sensations
- Pain with movement, exercise, or normal clothing
- Tenderness that does not improve over time
- Pain that disrupts sleep, work, or daily routines
Do You Qualify for an Internal Bra Mesh Lawsuit?
Many women do not learn that internal support material was used until complications begin. If your recovery has not followed the expected path and symptoms continue or worsen over time, you may have a case.
You may qualify if you have had one of the following procedures:
- Breast reconstruction
- Breast augmentation
- Breast lift surgery (mastopexy)
And you experienced one of the following complications:
- Infection
- Implant failure
- Breast deformity
- Chronic pain
- Skin necrosis (tissue death)
Speak With an Internal Bra Mesh Lawsuit Attorney at Farah & Farah
If you’ve been harmed as a result of a surgery that should have improved your life, you deserve to have someone on your side. Farah & Farah stands with patients who have been harmed by defective medical devices. Our defective medical device attorneys hold manufacturers accountable and fight for those dealing with unexpected complications and ongoing health issues.
Contact us anytime for a free consultation regarding your claim. You won’t have to pay anything unless your case is successful.
We’re here to help. Reach out to Farah & Farah today.
You can and should pursue justice through a defective medical device lawsuit. At Farah & Farah, we help you recover the maximum possible recovery or verdict from the people who caused your injury – so you can focus on recovering from what the defective medical device did to you without financial hardship.
FREE CASE REVIEW