Evidence map›Paper›PMID 27697885›Full record

ArticleAesthetic surgery journal2016

The History of GalaFLEX P4HB Scaffold.

Simon F Williams, David P Martin, Arikha C Moses

Open access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Aesthetic surgery journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it, 85 citations in OpenAlex.

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  11. Clinical outcomes of oncologic hernia repair using Poly-4-Hydroxybutyrate (P4HB) mesh.Hernia : the journal of hernias and abdominal wall surgery · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

Simon F WilliamsDr Williams is a Consultant to Tepha, Inc. and a member of the Tepha Board of Directors. Dr Martin is the Chief Scientific Officer of Tepha, Inc. Dr Moses is a Consultant to Tepha, Inc. and is the Founder of Galatea Surgical, Inc. Galatea Surgical, Inc. is a wholly owned subsidiary of Tepha, Inc.
David P MartinDr Williams is a Consultant to Tepha, Inc. and a member of the Tepha Board of Directors. Dr Martin is the Chief Scientific Officer of Tepha, Inc. Dr Moses is a Consultant to Tepha, Inc. and is the Founder of Galatea Surgical, Inc. Galatea Surgical, Inc. is a wholly owned subsidiary of Tepha, Inc.
Arikha C MosesDr Williams is a Consultant to Tepha, Inc. and a member of the Tepha Board of Directors. Dr Martin is the Chief Scientific Officer of Tepha, Inc. Dr Moses is a Consultant to Tepha, Inc. and is the Founder of Galatea Surgical, Inc. Galatea Surgical, Inc. is a wholly owned subsidiary of Tepha, Inc.
Tepha (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The GalaFLEX Scaffold (Galatea Surgical, Inc., Lexington, MA) for plastic and reconstructive surgery belongs to a new generation of products for soft tissue reinforcement made from poly-4-hydroxybutyrate (P4HB). Other members of this new family of products include MonoMax Suture (Aesculap AG, Tuttlingen, Germany) for soft tissue approximation, BioFiber Scaffold (Tornier, Inc., Edina, MN) for tendon repair, and Phasix Mesh (C.R. Bard, Inc., Murray Hill, NJ) for hernia repair. Each of these fully resorbable products provides prolonged strength retention, typically 50% to 70% strength retention at 12 weeks, and facilitates remodeling in vivo to provide a strong, lasting repair. P4HB belongs to a naturally occurring class of biopolymers and fibers made from it are uniquely strong, flexible, and biocompatible. GalaFLEX Scaffold is comprised of high-strength, resorbable P4HB monofilament fibers. It is a knitted macroporous scaffold intended to elevate, reinforce, and repair soft tissue. The scaffold acts as a lattice for new tissue growth, which is rapidly vascularized and becomes fully integrated with adjacent tissue as the fibers resorb. In this review, we describe the development of P4HB, its production, properties, safety, and biocompatibility of devices made from P4HB. Early clinical results and current clinical applications of products made from P4HB are also discussed. The results of post-market clinical studies evaluating the GalaFLEX Scaffold in rhytidectomy and cosmetic breast surgery demonstrate that the scaffold can reinforce lifted soft tissue, resulting in persistent surgical results in the face and neck at one year, and provide lower pole stability after breast lift at one year.

Indexed as

PolyestersTissue ScaffoldsHernia, InguinalHumansPlastic Surgery ProceduresSurgical MeshTendonspoly(4-hydroxybutanoate)Polyesters

Identifiers

PMID27697885
PMCPMC5070449
OpenAlexW2528323311

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.