Transvaginal Mesh Manufacturers and Public Product Identifiers
Last updated: April 2, 2026
Many people researching transvaginal mesh complications want to know which manufacturer made a product, what the product family was called, and whether any public FDA references may help with identification. This page is designed as a practical public-reference guide, not as a complete master list of every model, lot, or implant record ever used.
This page provides general educational information and does not constitute legal advice.
Why Product Identification Matters
In transvaginal mesh cases, product identification can be one of the most important factual issues. People often begin by trying to confirm the manufacturer, product family, and any public FDA references that may help connect a surgery to a specific device line.
In many situations, operative reports, implant stickers, hospital records, billing records, and revision surgery records are more useful than public databases alone.
Important Limitation on Model, Catalog, and Lot Information
Public records do not provide one complete, universal database showing every transvaginal mesh product together with every model number, catalog number, and lot number ever used. Some public FDA records clearly identify a product family. Some recall or adverse-event records may show a model or catalog reference. But those identifiers are not consistently available across all products and all manufacturers.
For that reason, this page is best understood as a guide to publicly identifiable product families rather than a complete lot-number reference.
Publicly Identifiable Manufacturers and Product Families
| Manufacturer | Product Family | Public FDA Reference | Notes |
|---|---|---|---|
| Ethicon | GYNECARE PROLIFT +M Pelvic Floor Repair Systems | K071512 | Public FDA clearance record identifies this product family by name. |
| Ethicon | TVT / pubourethral sling lineage | K974098 | Useful for older sling-related records and product-family research. |
| C.R. Bard | Avaulta Solo Synthetic Support System / Avaulta Plus Biosynthetic Support System | K083839 | Public FDA clearance record identifies both Avaulta families directly. |
| American Medical Systems | Apogee and Perigee Systems | K082387 | Public FDA materials identify these systems within the AMS pelvic floor repair family. |
| Boston Scientific | Pinnacle Pelvic Floor Repair Kits | K071957 | Public FDA materials identify the Pinnacle product family. |
| Boston Scientific | Uphold LITE / Xenform | Later FDA POP mesh materials | These products appear in the later FDA record surrounding the 2019 transvaginal POP mesh stop-sale action. |
| Coloplast | Restorelle DirectFix Anterior | Later FDA POP mesh materials | This product appears in the later FDA record surrounding the 2019 transvaginal POP mesh stop-sale action. |
How to Read These References
- 510(k) number: a public FDA premarket clearance reference tied to a device or product family.
- Product family name: often the most useful public starting point when reviewing older records.
- Catalog or model number: may appear in some recall or adverse-event records, but not consistently.
- Lot or batch number: may appear in some records, but there is no single complete public database covering all mesh products.
What Records Are Often More Useful Than Public Databases?
Anyone trying to identify the exact device used in a particular surgery will often need to look beyond public FDA records. The records that may be most useful include:
- Operative reports
- Implant stickers or implant logs
- Hospital billing records
- Surgeon records
- Revision surgery records
- Pathology or explant documentation
Public FDA records may help confirm that a product family existed and may help connect a name to a manufacturer. But they often do not replace a patient’s own medical records when exact device identification matters.
Why Later FDA History Still Matters
The FDA states that in 2019 it ordered manufacturers to stop selling and distributing surgical mesh intended for transvaginal repair of pelvic organ prolapse in the United States. That later regulatory history helps readers distinguish older product families from the narrower group of devices that remained part of the final FDA stop-sale action. [oai_citation:1‡U.S. Food and Drug Administration](https://www.fda.gov/medical-devices/implants-and-prosthetics/urogynecologic-surgical-mesh-implants?utm_source=chatgpt.com)
Common Questions People Ask
- How do I find out which transvaginal mesh product was implanted?
- Are model numbers and lot numbers publicly available?
- Which manufacturers were involved in transvaginal mesh litigation?
- Can FDA records help identify a product family?
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