What is the mechanism of action of this treatment?

Mesh-based breast reconstruction treatments work by providing structural support to the reconstructed breast using synthetic or biological mesh materials. These meshes act as scaffolds that reinforce the tissue and support the implant or tissue flap, promoting tissue integration and stability. This mechanism is crucial for achieving a natural breast shape and reducing complications such as implant displacement or capsular contracture. For patients, understanding these benefits is important as it can lead to better aesthetic outcomes and fewer postoperative issues.

What side effects are associated with this type of intervention?

Common side effects of breast reconstruction, including mesh-based procedures, involve infection, bleeding, pain, and scarring. Specific to mesh-based reconstructions, patients may experience mesh infection, mesh extrusion, chronic pain, seroma (fluid accumulation), and delayed wound healing.

What prior FDA approvals exist?

FDA approvals for breast reconstruction treatments have included various implants and tissue expanders designed to provide structural support. These devices are often used in conjunction with autologous tissue reconstruction or as standalone solutions. While specific mesh-based products for breast reconstruction are not detailed in the provided context, the use of mesh in surgical procedures is generally aimed at providing additional support and improving outcomes. For instance, acellular dermal matrices (ADMs) are commonly used in breast reconstruction to support implants and improve contour and projection.

What other types of research exist?

One promising novel alternative to mesh-based breast reconstruction is the use of resorbable synthetic meshes, such as poly-4-hydroxybutyrate (P4HB) mesh. These meshes provide the necessary structural support while gradually being absorbed by the body, potentially reducing long-term complications associated with permanent synthetic meshes. Another alternative is the use of biological meshes, such as acellular dermal matrices (ADMs), which are derived from human or animal tissues and support tissue integration and healing. Both options have shown positive outcomes in terms of safety and efficacy in recent studies.

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Mesh Implant

DuraSorb® Mesh for Breast Reconstruction

N/A

Waitlist Available

Research Sponsored by Surgical Innovation Associates, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special surgical mesh called DuraSorb® in women having breast reconstruction after mastectomy. The mesh helps support the new breast shape as it heals. The study will compare results with past surgeries that did not use any mesh. DuraSorb is designed for soft tissue reinforcement, known for its ease of handling and rapid tissue incorporation.

Who is the study for?

This trial is for women aged 22-70 planning to have breast reconstruction with a mesh after mastectomy. They must be able to attend all visits, understand the study, and consent. Exclusions include prior failed reconstructions or radiation at the site, extreme BMI values, certain medications, recent nicotine use, pregnancy plans during the study, and any health issues that increase surgery risks.

What is being tested?

The trial is testing DuraSorb®, a type of surgical mesh used in breast reconstruction post-mastectomy. It compares outcomes like safety and effectiveness between patients receiving this new mesh versus those who had similar surgeries without it.

What are the potential side effects?

While specific side effects are not listed here, surgical meshes can typically cause complications such as infection at the surgery site, pain or discomfort around the area where they're implanted, possible allergic reactions or rejection by body tissue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Clinical Success (CCS)

Local Complications of Breast Reconstruction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 Intervention

Group II: Historical Control ArmActive Control1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mesh-based breast reconstruction treatments work by providing structural support to the reconstructed breast using synthetic or biological mesh materials. These meshes act as scaffolds that reinforce the tissue and support the implant or tissue flap, promoting tissue integration and stability. This mechanism is crucial for achieving a natural breast shape and reducing complications such as implant displacement or capsular contracture. For patients, understanding these benefits is important as it can lead to better aesthetic outcomes and fewer postoperative issues.