If you suffered serious complications after a breast reconstruction, revision, augmentation, or “internal bra” procedure that used surgical mesh, an acellular dermal matrix (ADM), or a bioabsorbable scaffold, you may have a claim. The U.S. Food & Drug Administration has confirmed that no surgical mesh product has been cleared or approved for use in breast surgery — yet manufacturers continued to market these devices for breast procedures. Women have paid the price with revision surgeries, hospitalizations, deep infections, tissue erosion, permanent deformity, and disabling chronic pain.
Siddons Law Firm, PLLC is actively investigating these claims across Pennsylvania, New Jersey, New York, and Maryland.
Key Takeaways
- The FDA has not cleared any surgical mesh product for breast surgery. A November 2023 FDA safety communication confirmed this and required Becton, Dickinson (BD) to update labeling on GalaFLEX and related products.
- The 2021 FDA safety communication on acellular dermal matrix (ADM) products found significantly higher complication rates for FlexHD and AlloMax compared with AlloDerm, SurgiMend, or no ADM at all.
- There is no consolidated MDL for breast mesh / ADM / scaffold cases as of May 2026 — claims are being filed individually. The Allergan BIOCELL Textured Breast Implant MDL (MDL 2921, D.N.J.) covers BIA-ALCL lymphoma, not the mesh / ADM / scaffold complications addressed here; bellwether trials in that MDL are scheduled for June 2026 and October 19, 2026.
- Statutes of limitations are short — typically two years in PA and NJ, three years in NY, and three years in MD (subject to a 10-year statute of repose). Delay can be fatal to a claim.
Who Qualifies — Devices & Procedures Within Scope
If your procedure involved one of the following products and you suffered a serious complication, we want to hear from you.
Surgical mesh / bioabsorbable scaffold
- GalaFLEX / GalaFLEX LITE / GalaFLEX 3D / GalaSHAPE 3D (BD / Tepha / Galatea Surgical) — poly-4-hydroxybutyrate (P4HB) bioabsorbable scaffold cleared in 2014 (K140533) for general soft-tissue repair; never approved for breast surgery
- GalaFORM 3D
- Phasix (BD)
Acellular dermal matrix (ADM)
- AlloDerm (Allergan / AbbVie via LifeCell)
- AlloMax (BD via C.R. Bard)
- FlexHD (MTF Biologics)
- Strattice (Allergan / AbbVie via LifeCell) — porcine-derived
- SurgiMend
Procedures within scope
- Breast reconstruction (post-mastectomy)
- Breast revision surgery
- Breast augmentation
- “Internal bra” lift / mastopexy procedures
Qualifying Serious Complications
Minor or fully-resolved problems do not qualify. We are investigating cases involving one or more of the following:
- Revision or explant surgery (mesh, ADM, or scaffold removal)
- Hospitalization for an infection or wound complication
- Loss of reconstruction / reconstruction failure
- Permanent deformity of the breast
- Disabling chronic pain that has not resolved
- Tissue erosion (skin, capsule, or chest wall)
- Deep infection (cellulitis, abscess, or systemic infection)
- Multiple corrective procedures after the original surgery
Common Warning Signs
If you experienced any of these after a breast procedure involving mesh, ADM, or a scaffold, contact us — these are the early indicators that lead to the qualifying complications above.
- Infection or cellulitis at the surgical site
- Seroma or persistent fluid collection
- Wound breakdown or delayed healing
- Skin-flap necrosis or tissue compromise
- Implant, mesh, or scaffold malposition (visible or palpable shifting)
- Reconstruction failure
The MDL & Litigation Landscape (May 2026)
National status
As of May 2026, there is no certified class action and no JPML-consolidated MDL specifically for breast surgical mesh, ADM, or bioabsorbable scaffold claims. Cases are being filed individually in state and federal courts. Consolidation is expected to follow as case counts grow.
The closest active federal breast-implant docket is In re: Allergan BIOCELL Textured Breast Implant Products Liability Litigation, MDL No. 2921, pending in the District of New Jersey before Judge Brian R. Martinotti and Magistrate Judge Joseph A. Dickson. That MDL involves BIA-ALCL (breast-implant-associated anaplastic large-cell lymphoma) tied to Allergan’s recalled BIOCELL textured implants and tissue expanders — a different injury pathway from the mesh / ADM / scaffold complications addressed on this page. The MDL has roughly 1,400+ pending actions; bellwether trials are scheduled for June 2026 and October 19, 2026. If your case involves a recalled Allergan BIOCELL textured implant rather than mesh/ADM/scaffold complications, contact us about a separate intake.
Key FDA actions driving the litigation
- March 2021 — FDA Safety Communication on acellular dermal matrix products in implant-based breast reconstruction. FDA review of MROC study data found materially higher rates of major complications, explantation, infection, and reoperation in patients receiving FlexHD or AlloMax compared with AlloDerm, SurgiMend, or no ADM at all.
- November 9, 2023 — FDA letter to healthcare providers following Becton, Dickinson’s update of warnings and precautions on multiple mesh products. The label for BD’s GalaFLEX LITE scaffold now expressly states that the device “has not been studied for use in breast reconstructive surgeries.”
- November 2023 FDA Safety Communication — confirmed that no surgical mesh product has been cleared or approved for use in breast surgery. Continued off-label use for “internal bra” techniques is on notice.
Likely defendants
- Becton, Dickinson and Company (BD) — directly and via subsidiaries Tepha / Galatea Surgical (GalaFLEX product family) and through BD’s 2017 acquisition of C.R. Bard (AlloMax, Phasix)
- Allergan / AbbVie via LifeCell Corporation (AlloDerm, Strattice)
- MTF Biologics (FlexHD)
- Integra LifeSciences (SurgiMend, in some configurations)
State-by-State Filing Considerations — PA, NJ, NY, MD
Pennsylvania
PA has a two-year statute of limitations for product-liability personal-injury claims (42 Pa. C.S. § 5524), running from the date the plaintiff knew or, with reasonable diligence, should have known of the injury and its cause. PA’s discovery rule is a factual inquiry — many revision-surgery patients first learn the device may be defective only after explant pathology or a treating-surgeon discussion. The Eastern District of Pennsylvania is a natural federal venue for plaintiffs in our PA service area; the Philadelphia state court Complex Litigation Center has historically been favorable for mass-tort device cases.
New Jersey
NJ has a two-year statute of limitations under N.J.S.A. 2A:14-2, with the discovery rule available. The District of New Jersey already houses MDL 2921 (Allergan BIOCELL) and has deep experience with breast-implant device litigation under Judge Martinotti. NJ also has a robust Products Liability Act (N.J.S.A. 2A:58C-1 et seq.) that channels most failure-to-warn and design claims through a single statutory framework.
New York
NY’s product-liability statute of limitations is generally three years from injury under CPLR § 214(5), with the discovery rule available for certain device cases. The Southern and Eastern Districts of New York are common venues; New York County Supreme Court regularly handles complex device-litigation tracks. NY’s revival windows for certain torts do not currently extend to medical-device product liability, so the three-year clock is the controlling deadline.
Maryland
MD applies a three-year statute of limitations under Md. Code, Cts. & Jud. Proc. § 5-101, with a discovery rule, subject to a 10-year statute of repose from initial purchase / first sale of the product under § 5-108. The repose period is a hard outer limit — if the qualifying device was implanted more than ten years ago, even a meritorious case can be barred. The District of Maryland sits in the Fourth Circuit, which applies a relatively conservative learned-intermediary doctrine in failure-to-warn analyses.
Evidence We’ll Help You Gather
Successful claims turn on documentation. We will help you obtain:
- Operative reports identifying the device by brand and manufacturer (and lot/serial if available)
- Implant card or hospital purchase record confirming the specific device
- Pre- and post-operative medical records documenting the complications
- Revision / explant operative reports and pathology (if applicable)
- Hospital admission records (if hospitalized for the complication)
- Photographs of complications where appropriate (with patient consent)
- Damages documentation — medical bills, lost wages, and a treating-physician statement of permanence
Why Siddons Law
Siddons Law Firm, PLLC has built a multi-state mass-tort practice across Pennsylvania, New Jersey, New York, and Maryland, with offices in Media, PA and Rising Sun, MD. We take on complex medical-device cases against major manufacturers and pursue them aggressively from intake through verdict or settlement. When you call our office about a breast mesh, ADM, or scaffold claim, you speak directly with our team — there is no call-center middleman and no impersonal pipeline.
How to Start Your Case
There is no cost to call. Statutes of limitations are short — in PA and NJ, you have just two years, and in MD you face a 10-year repose period that can bar older cases entirely. The sooner we obtain your operative records and identify the device, the stronger the case.
Call (610) 255-7500 — or use the form below for a confidential case review. There is no fee unless we recover for you.
Frequently Asked Questions
Is there an MDL for breast mesh, ADM, or scaffold cases?
Not as of May 2026. Cases are being filed individually. The Allergan BIOCELL Textured Breast Implant MDL (MDL 2921, D.N.J.) is the most active breast-implant MDL but it covers BIA-ALCL lymphoma, not mesh / ADM / scaffold complications.
Did the FDA ever approve surgical mesh for breast surgery?
No. In November 2023 the FDA confirmed that no surgical mesh product has been cleared or approved for use in breast surgery. BD has updated labeling on the GalaFLEX product family to reflect that the device has not been studied for breast reconstruction.
What about acellular dermal matrix (ADM) products like FlexHD, AlloMax, AlloDerm, or Strattice?
ADMs are regulated differently from synthetic mesh, but in March 2021 the FDA issued a Safety Communication finding higher complication rates for FlexHD and AlloMax compared to other ADM brands or no-ADM controls. The FDA review found significantly elevated major-complication, explantation, infection, and reoperation rates within two years of surgery.
How long do I have to file a claim?
PA: two years; NJ: two years; NY: three years; MD: three years (subject to a 10-year statute of repose). All states have a discovery rule, but applying it correctly is fact-intensive. Do not delay.
What if my procedure was a cosmetic augmentation or “internal bra” lift, not a post-mastectomy reconstruction?
You can still qualify. The relevant question is whether the device was off-label for breast surgery and whether you suffered a qualifying serious complication. Cosmetic-procedure cases are part of the current investigation.
What if I no longer have the device — it was already removed in a revision or explant?
Explant pathology, the operative report from the revision/explant, and the implant card or hospital purchase record from the original procedure are typically enough to identify the device. We can help obtain these records.
Will I have to travel?
No. We handle cases across PA, NJ, NY, and MD remotely; consultations are by phone, video, or in-person at the Media, PA or Rising Sun, MD office.