OviTex PRS for Breast Reconstruction

(RESTORE Trial)

This trial tests a new treatment called OviTex PRS, a surgical mesh, to determine its safety and effectiveness for women undergoing implant-based breast reconstruction. It targets women having their first breast reconstruction immediately after a mastectomy, either due to cancer or as a preventive measure. Ideal candidates are non-smokers without previous breast surgeries, such as augmentation or reduction. The trial excludes individuals with certain health conditions or those on medications that affect healing. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in breast reconstruction.

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking medications that affect wound healing or increase postoperative risks, you may not be eligible to participate.

Research has shown that OviTex PRS, a special mesh made from sheep tissue, is generally safe for breast reconstruction. Studies indicate it functions similarly to other materials used in these surgeries, such as those made from human skin. In one study, about 22% of patients required additional surgery, often due to implant exposure or infection. Despite these risks, this treatment remains a safe and effective option for many undergoing breast reconstruction.¹²³⁴⁵

Unlike the standard of care for breast reconstruction, which often includes materials like silicone or saline implants, OviTex PRS is unique because it uses a biologic mesh derived from natural tissue. This mesh is designed to integrate more seamlessly with the body's own tissue, potentially enhancing healing and reducing the risk of complications. Researchers are excited about OviTex PRS because it offers a more natural repair method that could lead to better outcomes and faster recovery times for patients undergoing breast reconstruction.

Research has shown that OviTex PRS, a mesh made from sheep tissue, is effective for breast reconstruction. In studies comparing OviTex to other materials like STRATTICE, patients experienced softer breast implants, as measured by Baker grades. Another study found that OviTex performed as well as materials made from human tissue, offering a more affordable option for reconstruction. Patients using OviTex achieved similar success in reconstruction, proving it a reliable choice for those needing implant-based breast reconstruction.¹²³⁵⁶