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 in Global

Instructions for use delivery device

Insertion technique guide

Freedom Inguinal Repair System Brochure

Patient Brochure to help inform patients

For training & education opportunities please contact us


Useful Links

European Hernia Society
Click link here

Americas 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.

 

 

 

clinicalinguinal

The Freedom Inguinal Hernia Repair System with PROFLOR™

 

Proflor Overview

What is the Freedom Inguinal Repair system

 

profloringuinal

PROFLOR™ is a novel 3D dynamic polypropylene implant used in conjunction with a delivery device accessory which helps to constrain the device during placement into the hernia defect.

 

Fixation Free
The ProFlor device is made from well known, and clinically accepted polypropylene Is has a pre-peritoneal rear disk and a three dimensional core made of loops of reinforced mesh lamella. The reinforcement is achieved by a proprietary process of building up the mesh edges during the knitting process. When formed into lamella shapes they act as springs and this gives radial resilience to the structure.

radialresistance

The spring like structure is able to be compressed, but unlike other implants, it will spring back open. This radial recoil is a key part to how the device holds itself into the hernia opening without the need for fixation with sutures, tacks or tissue glues.

verticalbuffering

The unique open architecture of the implant means that is has no dense central core. This allows the implant to be compressed vertically when in the patient. This acts like a shock absorber under compression. The mixture of radial resilience and vertical shock absorbance make the implant very compliant when placed into the abdominal wall.

 

What kind of implant is it?

The device is a 3 Dimensional implant designed to completely fill the defect, rather than just cover it.

Current plugs are conical shaped, folded mesh that have no inherent resilience or pre-peritoneal disk. The problem with these types of plugs is that they have very dense regions of mesh at the "nose" of the plug and clinical studies have shown that plugs can shrink up to 70% volumetrically [1]

ProFlor has a cylindrical shape with no "nose", plus a pre-peritoneal disk which covers the surface of the core, protecting the spaces between the lamella while tissue grows in.

Proflor

[1] The SAGES manual of hernia repair - Brian P Jacob, Bruce Ramshaw - Springer press

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Won't all that material cause fibrosis?

Although ProFlor at first glance seems have a lot of material, it is actually comparable in weight to plugs with an onlay mesh, or systems like Ethicon PHS® . Although the "amount" of material is an important factor in how fibrosis can occur, both material and geometrical structure also play an important role. The rear disk, and the lamella walls are made from light weight, large pore PP mesh. The open structure means that the overall density of the implant is very low.

It should be noted that foreign bodies placed into patients have the potential to cause fibrotic and other adverse reactions. You should always counsel patients thoroughly regarding the placement and possible need for removal or revision of permanent implants.

Insightra has conducted extensive pre-clinical studies in the porcine animal model to look at the level of inflammatory reaction to the implant, which was seen to be in line with standard PP implants. They also looked at the quality of tissue ingrowth [2] which was published in Artificial Organs.

Porcine histology at 8 months post implant - Data on file at Insightra

[2] Artif Organs. 2011 Aug;35(8):E181-90. doi: 10.1111/j.1525-1594.2011.01272.x. Epub 2011 Jul 13.

Implantation Technique

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

 

Pre-clinical & Clinical data

Since 2007 Insightra Medical has been supporting reasearch into pre-clinical data regarding the biology of hernia disease. At the same time they have been studying the ProFlor Implant in animal models, and the tissue reactions associated to it. It has studied the device clinically through investigator sponsored studies. A summary of the clinical data can be found within the Technique Guide.

Click Here to Read The Latest Clinical Data

 

[1] Histological findings of the internal inguinal ring in patients having indirect inguinal hernia. Hernia 2009;13;259-62

[2] Reply to the letter: ”Histology of the internal inguinal ring: it is really a novelty?”. Hernia 2010;14:665-7

[3] Nerve degeneration in inguinal hernia specimens. Hernia 2011;15:53-58

[4] Damage to the vascular structures in inguinal hernia specimens. Hernia Online Journal DOI 10.1007/s10029-011-0847-4

[5] Muscle degeneration in inguinal hernia specimens .Hernia Online Journal DOI 10.1007/s10029-011-0890-1

[6] A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artificial Organs 2011;35(8):E181–E190

[7] Dynamic implant for inguinal hernia repair in porcine experimental model. A feasibility study. Hernia 2009;13:S1-332

[8] Dynamic autostatic implant for inguinal hernia repair. Early results in an explorative cohort of patients. Hernia 2010;14:S55-S100

[9] Fixation-free Inguinal Hernia Repair Using a Dynamic Self-retaining Implant. Surg Technol Int. 2012 Sep 30;XXII. pii: sti22/17.

 

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 Hernia 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.