GalaFLEX Breast Mesh Lawsuit Overview
Women are now pursuing GalaFLEX lawsuits after experiencing painful and sometimes permanent complications from the “internal bra” surgical mesh, which has been used in recent years during breast augmentation, breast reconstruction, breast lift and other cosmetic or reconstructive breast implant surgeries.
The breast mesh lawsuits allege that BD, C.R. Bard, Davol, Tepha and Galatea Surgical sold GalaFLEX for use in breast surgeries, even though the FDA has never approved GalaFLEX, or any other surgical mesh product, as safe and effective for that purpose.
GalaFLEX was originally cleared by the FDA through the 510(k) process as a surgical scaffold for the reinforcement of soft tissue where weakness exists. However, plaintiffs allege the manufacturers expanded sales of the mesh into breast surgery applications that went beyond the product’s cleared use, leading surgeons to implant GalaFLEX off-label without women being adequately informed that it had not been proven safe or effective for those procedures.
The complaints allege the manufacturers failed to conduct adequate testing or provide proper warnings about GalaFLEX breast mesh side effects, including chronic pain, inflammation, infection, scarring, hardening of breast tissue, deformity, implant problems and failed surgical outcomes, often requiring additional procedures because the mesh may become embedded in surrounding tissue and difficult or impossible to fully remove.
Who Qualifies for a GalaFLEX Breast Mesh Lawsuit?
Financial compensation through a GalaFLEX lawsuit settlement may be available for women who received a surgical mesh and later developed any of the following complications:
- Nerve damage
- Infection or abscess
- Seroma
- Hematoma
- Migration or displacement
- Skin necrosis
- Reconstructive failure
- Implant rupture
- Explant or revision surgery
To find out if you may be eligible to pursue a GalaFlex lawsuit, request a free consultation with one of our breast mesh attorneys. Our law firm works on a contingency fee basis, meaning there are no expenses or fees unless a settlement or recovery is obtained.
Index of GalaFLEX Lawsuit Info On This Page
What Is GalaFLEX Mesh?
FDA Breast Mesh Warnings
GalaFLEX Mesh Side Effects
GalaFLEX Mesh May Not Dissolve As Expected
GalaFLEX Mesh Removal Surgery
GalaFLEX Study Concerns Raised in Lawsuits
Manufacturers Knew GalaFLEX Was Being Used Off-Label
GalaFLEX Internal Bra Lawsuit Allegations
Who is the GalaFLEX Lawsuit Against?
How do I Know If GalaFLEX Mesh Was Used?
How Long Do I Have to File a GalaFLEX Lawsuit?
GalaFLEX Lawsuit Settlement Amounts
Speak With a GalaFLEX Breast Mesh Lawyer
What Is GalaFLEX Mesh?
GalaFLEX, also known as GalaFLEX Scaffold, is a bioresorbable synthetic mesh made from poly-4-hydroxybutyrate, commonly called P4HB. The FDA describes GalaFLEX as a sterile, knitted mesh made from non-dyed monofilament P4HB fibers provided in sheets that can be cut to the shape or size needed for a specific procedure.
The GalaFlex mesh was cleared through the FDA’s 510(k) process for use as a transitory scaffold for soft tissue repair and to reinforce deficiencies where weakness or voids exist. However, lawsuits allege the product became heavily used in breast surgeries even though it was not cleared or approved by the FDA as safe and effective for that specific use.
GalaFLEX has been used in breast reconstruction surgery and augmentations where surgeons want to reinforce tissue, support implants or improve the structure of the breast pocket. This may include:
- Breast augmentation
- Breast lift, also known as mastopexy
- Breast reconstruction after mastectomy
- Breast reduction
- Breast implant revision surgery
- Internal bra procedures
- Correction of implant drooping, malposition or asymmetry
- Procedures involving breast ptosis, thin skin or weakened tissue
GalaFLEX Internal Bra and Breast Support Uses
Some of the most common uses of GalaFLEX in breast surgery involve internal support, implant positioning, and correction of breast sagging. GalaFLEX and other internal bra mesh products are used to support tissue and maintain the shape of the breast after augmentation procedures. Surgeons may place GalaFLEX inside the breast pocket to act as a scaffold for breast tissue or implants, often as part of an “internal bra” technique.
In an internal bra procedure, GalaFLEX mesh functions like a sling to reinforce weakened tissue, provide structural support, help maintain shape and implant position, or reduce the risk of sagging after a breast lift, augmentation, reconstruction, or revision procedure.
GalaFLEX has also been used in procedures involving breast ptosis, which refers to sagging or downward displacement of the breast tissue and nipple. Ptosis may occur naturally with age, pregnancy, weight changes, or reduced skin elasticity, and it may also develop after breast augmentation or reconstruction. In these situations, surgeons have used GalaFLEX to support the lower portion of the breast, reshape the implant pocket, correct asymmetry, or address implant movement by supporting internal tissue.
However, internal bra mesh lawsuits allege that problems may arise when the mesh does not perform as expected after it is placed in the breast. Research has shown that GalaFLEX may become incorporated into surrounding tissue, scar tissue, or the implant pocket, which can make breast mesh complications harder to diagnose and more difficult to correct. Those risks take on added significance because FDA warnings have made clear that surgical mesh products, including GalaFLEX, have not been determined to be safe and effective for breast surgery.
FDA Breast Mesh Warnings
The FDA has not approved GalaFLEX, or any other surgical mesh product, as safe and effective for use in breast procedures. This includes breast augmentation, breast reconstruction, breast lift and other cosmetic or reconstructive breast surgeries.
According to lawsuits, while GalaFLEX was cleared for certain general soft tissue reinforcement, the FDA has warned doctors that the safety and effectiveness of surgical mesh in breast surgery has not been established. The FDA warning specifically included surgical mesh used in breast augmentation or reconstruction procedures. The warning clearly stated:
“The FDA is aware of increased use of surgical mesh products in breast surgery. However, the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.”
GalaFLEX lawsuits allege this distinction is important because women may not have known the mesh placed in their body had never been approved for breast surgery use. The complaints claim manufacturers failed to provide adequate warnings about this issue and the risks women could face after implantation.
GalaFLEX Mesh Side Effects
Women are filing GalaFLEX mesh side effect lawsuits after developing complications following augmentation, reconstruction, lift or revision surgery. These side effects may appear soon after surgery or develop later as scar tissue forms, the implant pocket changes or the mesh fails to dissolve as expected.
Potential GalaFLEX Mesh Side Effects
- Chronic breast pain: Persistent pain may develop near the GalaFLEX mesh, implant pocket or surgical site. Some women describe ongoing tenderness, burning, pulling, sharp pain or discomfort that does not resolve after the normal healing period.
- Capsular contracture: Capsular contracture occurs when scar tissue tightens around a breast implant or implant pocket. This can cause hardening, pain, distortion, implant displacement or an unnatural breast appearance. GalaFLEX lawsuits allege the mesh may contribute to inflammatory reactions or tissue changes that increase this risk.
- Infection or abscess formation: Infection may occur when bacteria develop around the implant, mesh or surrounding tissue. Severe infections may require antibiotics, drainage, hospitalization, implant removal or GalaFLEX mesh removal surgery.
- Seroma or chronic fluid buildup: A seroma is a pocket of fluid that develops after surgery. When fluid buildup becomes persistent or recurrent, it may cause swelling, discomfort, pressure, delayed healing or the need for drainage procedures.
- Inflammatory tissue reactions: Some women may develop inflammation, swelling, irritation or abnormal tissue response around the mesh. Lawsuits allege GalaFLEX may cause adverse tissue reactions when used in breast procedures, especially if the mesh remains in the body longer than expected.
- Skin erosion or tissue necrosis: Tissue damage may occur if the skin or surrounding breast tissue breaks down near the mesh or implant. Skin necrosis involves tissue death and may require wound care, debridement, reconstruction or additional corrective surgery.
- Nerve pain or nerve damage: GalaFLEX mesh complications may involve nerve irritation, nerve entrapment or nerve injury. This can cause shooting pain, numbness, tingling, burning sensations or long term sensitivity in the breast or chest area.
- Mesh migration, folding or displacement: If the mesh shifts, folds, tightens or does not remain properly positioned, it may affect the breast pocket, implant support or surgical result. This may contribute to pain, asymmetry, implant malposition or failed correction.
- Implant drooping, asymmetry or malposition: When GalaFLEX does not provide the intended support, women may experience recurrent sagging, uneven breasts, implant displacement or an unsatisfactory cosmetic result. Some women may require revision surgery to correct the problem.
- Implant rupture, implant loss, implant failure, or reconstruction failure: In more serious cases, GalaFLEX mesh complications may contribute to implant rupture, implant loss, implant failure, failed reconstruction, or the need to remove and replace implants. These serious complications often require removal or revision surgery and can be especially devastating for women who underwent breast reconstruction after mastectomy.
- Scarring or disfigurement: Repeated inflammation, tissue damage, infection or revision surgery may leave women with visible scarring, breast deformity or permanent cosmetic changes.
- Need for GalaFLEX removal or revision surgery: Many GalaFLEX mesh lawsuits involve women who required additional surgery because of pain, infection, capsular contracture, mesh complications or failed breast surgery results. Removal may be difficult if the mesh has become incorporated into scar tissue or surrounding breast tissue.
Lawsuits allege GalaFLEX mesh malfunctions can lead to nerve entrapment, skin necrosis, mesh erosion, infections, seroma, chronic pain, implant loss, implant failure, and other debilitating conditions. They also allege the manufacturers failed to adequately warn women and doctors about these risks before the product was used in breast surgery.
Warning Signs of GalaFLEX Mesh Problems
Some women may not immediately realize their symptoms are related to GalaFLEX mesh. Problems may develop gradually after breast surgery, especially as scar tissue forms, the implant pocket changes or the mesh fails to dissolve as expected.
Warning signs that may require medical evaluation include:
- Persistent pain under the breast fold, lower breast or chest wall
- New or worsening breast firmness
- Swelling, redness or warmth near the surgical area
- Fluid buildup or recurring seroma
- Burning, pulling, numbness or nerve-like pain
- Implant shifting, drooping or uneven breast appearance
- Skin thinning, wound problems or delayed healing
- Feeling mesh or hardened material under the skin
- Need for revision surgery after a failed breast procedure
Women experiencing these symptoms after GalaFLEX was used during breast surgery may want to request their operative records and speak with a breast mesh lawyer about whether they qualify for a claim.
GalaFLEX Mesh May Not Dissolve As Expected
GalaFLEX is described as a resorbable mesh, meaning it is intended to provide temporary support and then gradually break down in the body over about 12 to 18 months.
However, GalaFLEX lawsuits allege the mesh may not degrade or resorb as expected after it is placed in breast tissue. Instead, the mesh may remain in the body, become incorporated into surrounding tissue, and contribute to long-term complications.
When GalaFLEX does not break down properly, lawsuits allege it may:
- Become embedded in breast tissue or scar tissue
- Tighten around the implant pocket
- Contribute to capsular contracture
- Cause chronic pain or inflammation
- Make removal surgery more difficult
- Lead to failed breast surgery results
For women who develop pain, breast hardening, implant problems or tissue damage, the alleged failure of GalaFLEX to dissolve may turn a temporary support mesh into an ongoing medical problem that requires removal or revision surgery.
GalaFLEX Mesh Removal Surgery
Some women who suffer GalaFLEX mesh side effects may require removal surgery or additional revision procedures. This may happen when GalaFLEX is linked to:
- Chronic breast pain
- Capsular contracture
- Infection
- Tissue damage
- Implant problems
- Failed cosmetic or reconstructive results
GalaFLEX removal may be more complicated than a routine implant exchange. The mesh may become incorporated into breast tissue, scar tissue or the implant pocket. As a result, surgeons may need to remove mesh, capsule tissue, damaged tissue or implants during the same procedure.
Women who required GalaFLEX removal surgery may have stronger claims because removal often shows that the mesh caused a serious medical problem requiring additional treatment.
GalaFLEX Study Concerns Raised in Lawsuits
GalaFLEX Ptotic Breast Study
A 2018 study published in the Aesthetic Surgery Journal evaluated GalaFLEX in women undergoing breast lift and breast reduction procedures for ptosis, or sagging breast tissue. The study looked at whether GalaFLEX helped support breast tissue and maintain surgical correction after these procedures.
The study reported several complications in patients who received GalaFLEX, including:
- Nerve pain that required treatment with a steroid injection
- Breast swelling
- Recurrent ptosis, or sagging of the breast tissue
- Breast asymmetry
- GalaFLEX scaffold removal
- GalaFLEX scaffold release, or loosening, to address breast constriction
GalaFLEX Breast Reconstruction Long-Term Safety Questions
A study published in Plastic and Reconstructive Surgery in October 2022, titled Evaluation of the Safety of a GalaFLEX-AlloDerm Construct in Prepectoral Breast Reconstruction, evaluated GalaFLEX in prepectoral breast reconstruction. The publication compared use of a GalaFLEX-AlloDerm construct with AlloDerm alone.
- More long-term safety data was needed
- More clinical experience was needed
- Foreign body response was a concern
- Chronic inflammatory response was a concern
- Longer follow-up was needed because GalaFLEX may take up to two years to degrade and fully resorb
The publication specifically noted that only a limited portion of patients had at least two years of follow-up, even though longer follow-up was needed to assess risks tied to degradation and foreign body response.
GalaFLEX Failure to Dissolve After Breast Surgery
A study published in the Aesthetic Surgery Journal in 2025, titled Histomorphologic Outcomes of GalaFLEX Scaffold Used in Breast Surgery: Clinical Follow-up From 6 Weeks to 63 Months, examined GalaFLEX tissue samples removed from women after breast surgery. The samples were taken during later revision procedures, with follow-up ranging from 6 weeks to 63 months after implantation.
The study examined how GalaFLEX appeared in breast tissue over time, with findings that included:
- GalaFLEX material remained visible in breast tissue samples after implantation
- Earlier samples showed no appreciable degradation
- Later samples showed fiber fragmentation
- Samples came from women undergoing revision procedures
Manufacturers Knew GalaFLEX Was Being Used Off-Label
GalaFLEX lawsuits allege the manufacturers knew the mesh was being used in breast procedures, even though the FDA had not approved GalaFLEX as safe and effective for breast surgery. The complaints point to medical publications, physician payment records and breast surgery studies as evidence that GalaFLEX use in breast procedures was known and foreseeable.
According to the lawsuits, GalaFLEX had been discussed or studied for several breast-related uses, including:
- Breast lift, also known as mastopexy
- Breast reduction
- Breast reconstruction
- Internal bra procedures
- Correction of ptosis, or breast sagging
- Implant support and breast pocket reinforcement
The complaints allege Tepha reported nearly 200 payments to plastic surgeons in 2020, including consulting fees. They also cite a 2016 publication in which a plastic surgeon described routinely using GalaFLEX in patients with sagging breasts, with the publication disclosing funding by Galatea Surgical, a Tepha subsidiary.
Other publications cited in the lawsuits discussed GalaFLEX use in breast reduction, mastopexy and breast reconstruction. One article disclosed that an author served on an advisory board for BD, which provided the GalaFLEX scaffolds, while another article involving GalaFLEX breast reconstruction disclosed that one of the authors was a consultant for the GalaFLEX manufacturer.
These allegations support a central issue in GalaFLEX lawsuits: breast use was not an isolated or unexpected event. The lawsuits claim the manufacturers knew GalaFLEX was being used in breast surgery, while women were not adequately warned that the FDA had not determined the product to be safe and effective for that purpose, or that complications could require removal or revision surgery.
GalaFLEX Internal Bra Lawsuit Allegations
GalaFLEX lawsuit allegations focus on whether the manufacturers sold a defective internal bra mesh product for breast surgery use without adequate testing, warnings, or removal guidance. The lawsuits allege BD, Bard, Davol, Tepha, and Galatea Surgical:
- Sold GalaFLEX for use in breast surgeries
- Failed to properly test GalaFLEX for breast procedures
- Failed to warn that GalaFLEX had not been approved by the FDA for breast surgery use
- Failed to warn that the mesh may not dissolve or resorb as expected
- Failed to disclose the risk of painful complications
- Failed to properly investigate adverse event reports
- Failed to provide adequate guidance for removing GalaFLEX after complications developed
The lawsuits include claims for negligence, strict product liability, failure to warn, breach of implied warranty, fraud, and punitive damages.
Who is the GalaFLEX Lawsuit Against?
Recent GalaFLEX lawsuits name several companies involved with the design, manufacture, sale or distribution of GalaFLEX mesh. The defendants include:
- Becton, Dickinson and Company, also known as BD
- C.R. Bard Inc.
- Davol Inc.
- Tepha Inc.
- Galatea Surgical Inc.
The complaints allege Tepha and Galatea were involved with the resorbable polymer mesh technology used in GalaFLEX. BD later acquired Tepha, and lawsuits allege BD, Bard, Davol, Tepha and Galatea were involved in bringing GalaFLEX into use for breast procedures.
GalaFLEX Mesh Lawsuit Investigations
Lawyers are investigating GalaFLEX mesh lawsuits involving several GalaFLEX product lines used during breast procedures. These products may appear in operative reports, product stickers, implant records or surgical facility records.
GalaFLEX breast mesh products under investigation include:
- GalaFLEX Scaffold
- GalaFLEX 3D Scaffold
- GalaFLEX 3DR Scaffold
- GalaFLEX LITE Scaffold
- GalaFLEX LITE 3D Scaffold
- GalaFLEX LITE 3DR Scaffold
These investigations involve women who received GalaFLEX mesh during breast augmentation, breast lift, breast reconstruction, breast reduction, revision surgery or internal bra procedures, and later suffered complications such as pain, infection, capsular contracture, tissue damage, implant problems or the need for removal surgery.
How do I Know If GalaFLEX Mesh Was Used?
Many women do not know whether GalaFLEX was used during their breast surgery. Some patients may only remember being told that the surgeon planned to use:
- Mesh
- Scaffold material
- Absorbable support
- P4HB mesh
- An internal bra
- Support material for implants or breast tissue
The best way to confirm whether GalaFLEX was used is to review your surgical records. Records may identify the product as:
- GalaFLEX
- GalaFLEX Scaffold
- P4HB scaffold
- Galatea
- Tepha
- BD
- Bard
- Davol
Women seeking to identify which mesh was used during their procedure may also contact their surgeon to request this information.
If you are unsure whether GalaFLEX was used, Saiontz & Kirk can help review your records and determine whether you may qualify for a GalaFLEX lawsuit.
How Long Do I Have to File a GalaFLEX Lawsuit?
The deadline to file a GalaFLEX lawsuit depends on the statute of limitations in your state. These deadlines may depend on several dates, including:
- When GalaFLEX was implanted
- When symptoms first developed
- When you learned GalaFLEX may be linked to your injuries
- When revision or removal surgery occurred
- When a doctor identified mesh-related complications
Women who suffered complications after GalaFLEX mesh was used during breast surgery should consult a breast mesh lawyer as soon as possible. A breast mesh lawyer can help you understand how and when to file a breast mesh claim, ensuring you meet all eligibility criteria and timing deadlines. Waiting too long may prevent you from filing a claim, even if the mesh caused serious injuries.
GalaFLEX Lawsuit Settlement Amounts
There are no established average GalaFLEX lawsuit settlement amounts at this early stage of the breast mesh litigation. The value of a GalaFLEX mesh lawsuit, as with other breast mesh claims, will depend on the specific facts of each case, including the severity of the injury and the medical treatment required. Compensation in breast mesh cases and ongoing breast mesh litigation is influenced by factors such as the extent of damages, supporting evidence, and the details unique to each claim.
Factors that may affect settlement value include
- Whether GalaFLEX removal surgery was required
- Whether implants had to be removed or replaced
- The number of revision procedures
- The severity of pain or infection
- Whether capsular contracture developed
- The extent of scarring or breast deformity
- Future medical needs
- Lost wages or reduced earning ability
- The impact on quality of life
Cases involving removal surgery, failed reconstruction, permanent breast deformity, chronic pain or multiple corrective procedures may have greater potential value than claims involving short-term complications.
Speak With a GalaFLEX Breast Mesh Lawyer
If GalaFLEX mesh was used during your breast augmentation, breast lift, breast reconstruction, breast reduction or revision surgery, and you later suffered complications, you may be eligible to pursue a GalaFLEX lawsuit.
Saiontz & Kirk is reviewing claims for women who experienced:
- Painful GalaFLEX mesh side effects
- Failed breast surgery results
- GalaFLEX removal surgery
- Implant replacement or revision surgery
- Long-term complications after breast mesh use
Our lawyers can help determine whether GalaFLEX was used, review your medical records and explain whether you may qualify for compensation.
Contact our GalaFLEX mesh lawsuit lawyers today for a free consultation. There are no fees or expenses unless a settlement or recovery is obtained.
FIND OUT IF YOU QUALIFY FOR A GALAFLEX MESH LAWSUIT SETTLEMENT