NOTE: This section of the website is intended for healthcare professionals and may contain images of surgery. For patient information please click here


Important Information: Click the links below

Instructions for use Octomesh

Insertion technique guide

Freedom Octomesh Ventral Hernia Repair System Brochure

For training & education opportunities please contact us

Full data submitted to the FDA for Octomesh


Useful Links

Americas Hernia Society
Click link here

European Hernia Society
Click link here

Asia Pacific Hernia Society
Click link here

FDA on hernia mesh
Click link here

 

 


Legal note:

Insightra medical does not endorse or imply it agrees with the information contained in these external sites. The above links are placed as supplemental help for clinicians wishing to understand more about hernia repair. By clicking on the links, clinicians accept that following these links takes them to external sites.

 

 

 

clinicalventral

Octomesh
no tacks no sutures

Octomesh full

 

 

The STRAP TECHNIQUE
The Freedom Octomesh™ implant is designed to be used in open ventral hernia repair. It is placed as a sublay mesh. It can be placed above the peritoneum or above the retrorectus fascia. The eight anchoring straps of the Octomesh™ implant are used to stabilise the body of the implant by friction within the abdominal wall while the tissue integrates into the mesh body. A special strap passer is used to tunnel the anchoring straps.

Octomesh Placement

The Octomesh™ is placed broadly above the peritoneum. The eight anchoring straps are positioned radially and pulled through the abdominal wall muscles.

The Octomesh™anchoring straps are pulled through the layers of the abdominal wall to hold the body of the mesh in place during the phase of tissue ingrowth.

 

No Sutures. No Tacks.
Eight anchoring straps use frictional securement to ensure a stable implant during the critical
early post-operative period.(1)

Octomesh Clinical

Designed to Improve patient outcomes.

Octomesh pain data

1. Amato, et al. The use of a tailored mesh with special design for ventral hernia repair: Preliminary report. Hernia (2009) 13 (Suppl.1):S73-S104 P15
2. Data on file, Report P0124
3. Data on file, Report P0142

5 Product Kits

Octomesh Kits

octomeshkit

Octomesh™ is packaged in a convenient tray system - designed to reduce handling of the implant until it is ready to be implanted. Each kit is complete with an ergonomic strap passer. The implant is loaded on a unique white plastic carrier that protects the implant and allows a clean transfer to the operating site.

 

Implantation Technique

For a full description of the implant technique refer to the Instructions for Use and the
Implantation Technique Guide.

 

Important information from the FDA about PP Implants

Please read this advice from the FDA and consult fully with your patients.

Please follow this link to the FDA

Information on Surgical Mesh for Hernia Repairs
FDA wants to inform you about complications that may occur with the surgical mesh that is sometimes used to repair hernias, and to provide you with questions you may want to ask your surgeon before having this procedure. This is part of our commitment to keep the public informed about the medical products we regulate.

Hundreds of thousands of hernia repair operations are performed each year both with and without surgical mesh, and patients generally recover quickly and do well after surgery.

However, FDA has received reports of complications associated with the mesh. The complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels . Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence.

Most of the complications reported to us so far have been associated with mesh products that have been recalled and are no longer on the market. For further information on the recalled products, please visit the FDA Medical Device Recall website.

We are continuing to analyze and evaluate incoming reports of adverse events, and are speaking with patients, surgeons and researchers. We will inform the public as new information becomes available.

Talking to your doctor
Before having a hernia operation, be sure to let the surgeon know if you’ve had a past reaction to materials used in surgical mesh or sutures, such as polypropylene.

There are also certain questions you should consider asking your surgeon:

What are the pros and cons of using surgical mesh in my particular case?
If surgical mesh will be used, is there special patient information that comes with the product, and can I have a copy?
If surgical mesh will be used, what’s been your experience with this particular product, and with treating potential mesh complications?
What can I expect to feel after surgery and for how long?

Reporting complications to the FDA
In order to help FDA learn more about possible problems with surgical mesh, it’s important that both physicians and patients report complications that may be associated with this product.

You can report any problems to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Online : MedWatch Online Voluntary Reporting Form (3500)
Regular Mail : use postage-paid FDA form 3500 available at: MedWatch Forms
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
FAX: 1-800-FDA-0178

 

Training & education opportunities

Insightra Medical provides multiple training resources for the Freedom Inguinal Ventral Repair System.

Training Centers - Our surgical training programs are conducted around the world and have welcomed world renowned hernia surgeons to a hands on, multiple day program that includes the entire Freedom Hernia product line.

Surgeon Collaboration and Proctoring – Other surgeons are willing to share their knowledge and experience of the Insightra Medical Freedom Hernia Products.

Inservice Training – Insightra Medical authorized representatives are available for in house training and product support during initial cases.

Please contact us to request more information on training & education.