Important Information: Click the links below

Instructions for use in English

Instructions for use multilingual

Insertion technique guide

Freedom ProFlor Brochure

Patient Brochure to help inform patients

For training & education opportunities please contact us


Useful Links

Americas Hernia Society
Click link here

European Hernia Society
Click link here

Asia Pacific Hernia Society
Click link here

FDA on hernia
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

Latest Randomized Controlled Trial: ProFlor vs Lichtenstein

In June 2014 Dr. John Murphy MD initiated an RCT for ProFlor vs Lichtenstein. The end points were to compare pain via the VAS score, and Quality of Life (QOL) via the Carolinas Comfort Scale (CCS) a recognized hernia specific QOL system.

The initial 7 day data was reported at the Asia Pacific Hernia Society meeting in 2014. The full 30 day report will be presented to the 1st World Congress of Hernia in Milan (April 2016)

 

Initial Results

7 day results

 

 

Outcomes

As predicted, the ProFlor with its absence of Onlay mesh and no fixation during the 25 implantations was shown to have a significantly lower VAS score than the Lichtenstein procedure which places mesh in the anterior space, close to anterior nerve structures.

The CCS score (which includes pain and mesh sensation) was significantly lower with ProFlor compared to Lichtenstein.

CONTACT us here to discuss an evaluation

 

Other Longer Term Clinical Studies

Insightra medical believes that both patients and care givers should be given access to all the available clinical data on any permanent implant. This will allow both, through educated dialogue, to determine which implant, medical procedure and technique is best suited to the patient.

Outcomes

Clinical problem and an obvious solution

no onlay

Clinical References

References

 

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.