Three new mesh products for muscle and tendon injuries have been given fast track approval, sparking our concerns about what happens if a patient suffers complications.

The polyeurethane plastic mesh weave made by Artelon is designed to break down over six years and has been tested in mini pigs, guinea pigs, rats and rabbits.

Artelon claim it has caused no sensitivity issues or adverse responses in animals – so claims it is biocompatible in humans.

However, we are concerned about what will happen long term if it causes issues like pain, mobility issues or infection?

Our advocacy work means we know that if a patient is suffering in the weeks, months or even years after mesh surgery, the mesh devices are almost impossible to remove in their entirety, if at all.

It is complex and risky surgery – often leaving people with irreversible, life altering pain, worse than the problem it was originally intended to fix.

The three new mesh products, which have been cleared for use by America’s regulator the FDA, are intended for soft tissue repair and reinforcement including:

• Reinforcement of rotator cuff in shoulder
• Patella in knee
• Achilles in heel
• Biceps
• Quadriceps tendons
• Medial collateral ligament
• Lateral collateral ligament
• Spring ligament
• Deltoid ligament
• Ulnar collateral ligament or other tendons or extra-articular ligaments.

The devices are NOT intended for use, “to replace normal body structure or provide the full mechanical strength.”

Instead, sutures, provide the mechanical strength for the tendon repair while Artelon says its mesh products reinforce soft tissue and provide a degradable scaffold that is incorporated into the patient’s own tissue.

In short, Artelon claims its product, improves outcomes.

However, our experience as patient advocates, is that mesh products with plastic within the material, can cause pain, infection and can trigger a host of autoimmune conditions including ibs, allergies, dry eyes, sjorgens syndrome, Hashimoto’s and lupus.

A high number of our members – around two thirds – have suspected fibromyalgia believed to be caused by the plastic mesh implant.

New research from King’s College London, in collaboration with the University of Liverpool and the Karolinska Institute, has shown that fibromyalgia is a disease of the immune system, rather than the currently held view that it originates in the brain.

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to three surgical mesh products. It is a fast track approval route that gives a product the green light if it is seen as equivalent to another product already on the market

According to the FDA’s 510(k) summary document, the products are knitted mesh made from fibers “made of degradable polycaprolactone-based polyurethane urea.” The construction of the fibers “permits the mesh to be cut into any desired shape or size without unraveling.” Additionally, the devices “have suture attached to each end of the knitted mesh strip. The pre-loaded suture is intended to aid in usability in the operating room. The devices are supplied sterile, one product per package in double layer peel pouch packaging.”

Artelon’s products reinforce soft tissue and provide a degradable scaffold