Published by If you received a breast reconstruction, lift or augmentation using FlexHD mesh and later experienced complications such as revision surgery, chronic pain, implant failure, or mesh removal—you may be eligible for a FlexHD lawsuit.
Contact our experienced medical-device legal team today for a free case evaluation—no fees unless you recover compensation.
Table Of Contents
What’s the Problem?
FlexHD is a biologic acellular dermal matrix (ADM) mesh produced by Ethicon (a Johnson & Johnson subsidiary), originally cleared for soft-tissue reinforcement in general surgery—not for use as a “support sling” in breast reconstruction or augmentation. [1]
Despite lacking FDA clearance for breast applications, FlexHD has been widely used off-label in breast surgeries marketed as an “internal bra” technique.
Recent FDA safety communications show higher complication rates for ADM products used in implant-based breast reconstruction—particularly mentioning FlexHD and AlloMax ADM brands. [1]
These developments lay the groundwork for potential claims dubbed a FlexHD lawsuit, centered on design defects, off-label marketing and inadequate warning.
Latest FlexHD Updates
- March 31, 2021 – The FDA issued a safety communication reporting significantly higher complication rates (e.g., implant removal, infection, reoperation) in patients using certain ADM products including FlexHD in breast reconstruction. [1]
- October 15, 2025 – Industry reports note growing investigation by attorneys into breast mesh implant litigation involving internal-bra use of flexHD and other biologic meshes. [2]
- November 2025 – Plastic-surgery journals publish meta-analysis showing ADM mesh used in breast procedures is linked to higher rates of complications than non-mesh reconstructions. [3]
Product & Usage Overview
FlexHD is derived from decellularized human dermal tissue processed into a scaffold for tissue ingrowth. It is cleared for general tissue reinforcement, but not explicitly for breast reconstruction or augmentation.
In the “internal bra” technique, surgeons use it to reinforce the breast lower pole, support implants or correct sagging post-augmentation or mastopexy.
This off-label use places the material into a very different environment—subject to motion, hormonal change, implant weight and distinct biomechanics.
Studies indicate traditional approvals (for abdominal wall or chest repair) may not translate to safe performance in breast tissue. [3]
Injuries & Side Effects
Reported problems connected with ADM use in breast surgeries—and potentially an issue in a FlexHD lawsuit—include:
– Implant infection or abscess requiring mesh/implant removal
– Seroma (persistent fluid accumulation) or breast edema
– Implant sagging or bottoming-out due to premature mesh loss of strength
– Mesh bunching, migration or detachment and visible implant deformity
– Skin/tissue necrosis, chronic pain or nerve injury around breast pocket
– Revision surgery, explantation or reconstructive failure
These complications can cause physical, emotional and financial burdens for patients.
Do You Qualify for a FlexHD Lawsuit?
You may qualify if you:
– Underwent breast reconstruction, lift or augmentation where FlexHD mesh was used
– Experienced complications such as revision or explant surgery, pain, implant failure, infection, or mesh-related deformity
– Possess records confirming use of FlexHD or similar ADM mesh
– Are within the statute of limitations in your state (typically one to three years from discovery of injury)
Evidence Required for a Claim
Important documentation includes:
– Surgical notes specifying FlexHD or human-dermal mesh used
– Explantation or revision records and pathology reports
– Medical imaging or photographs illustrating mesh failure, migration or implant distortion
– Treatment records, bills and notes of pain/therapy
– Marketing materials or surgeon consent forms referencing internal-bra mesh use
Damages You Can Recover
Claimants may recover:
– Medical expenses for mesh removal, revision surgery and rehab
– Lost wages, diminished earning capacity or activity limitations
– Pain and suffering, emotional distress and loss of quality of life
– Disfigurement or permanent deformity compensation
– Punitive damages if evidence shows manufacturer knowingly marketed off-label use without full safety data
Legal Grounds & Liability Theories
Main legal theories in a FlexHD lawsuit include:
– Defective design: FlexHD was not engineered or tested for the environment of breast tissue and may fail prematurely
– Failure to warn: Manufacturers did not clearly inform surgeons or patients that the mesh was not approved for breast surgery
– Negligent marketing: Promotion of the mesh for “breast support” when clinical data was lacking or absent
– Strict liability: The product caused injury despite being used in a foreseeable manner
Though no specific flexHD lawsuit has been publicly filed under that exact brand name, attorneys are investigating claims around “internal bra” mesh use—placing flexHD within the scope of potential litigation.
Statute of Limitations & Timing
Deadlines vary by state but generally range from one to three years after injury discovery or revision surgery. Mesh-related injuries can emerge slowly—so early legal evaluation in any potential FlexHD lawsuit is critical to protect your rights.
Frequently Asked Questions
- Was FlexHD approved for breast reconstruction? – No. The FDA has stated that no mesh is cleared for breast surgery. [1]
- Do I need revision surgery to bring a claim? – Not necessarily. If you have documented complications or mesh-related symptoms you may still qualify for a FlexHD lawsuit.
- Is there already a class action for FlexHD? – Not known yet; however, broad litigation involving internal-bra mesh is developing. [2]
- Should I stop using my implant? – Consult your physician; removal may be advised depending on complications—but taking legal action promptly is still advised.
Why You Should Act Now
If you underwent breast mesh surgery with FlexHD and suffered implant problems, chronic pain or revision surgery—you should reach out for legal counsel now. Early action helps preserve vital surgical records, imaging and mesh tracking, strengthen your position in a FlexHD lawsuit, and optimize your ability to seek compensation.
Although no suit specific to FlexHD is publicly filed, the growing internal-bra mesh investigations indicate the potential for litigation—and you may need to act quickly to protect your rights.
Related Articles:
References
- https://www.fda.gov/news-events/fda-brief/fda-warns-about-differing-complication-rates-acellular-dermal-matrix-type-surgical-mesh
- https://www.aboutlawsuits.com/breast-mesh-lawsuit/
- https://journals.lww.com/annalsplasticsurgery/fulltext/2021/01000/concerns_regarding_the_use_of_acellular_dermal.1.aspx