Symbotex Hernia Mesh by Covidien - Defects and Legal Claims

The Covidien Symbotex is an implantable hernia mesh that is used to treat ventral hernias through laparoscopic surgeries. The Symbotex is manufactured and sold by Covidien, a subsidiary of Medtronic. Unlike many other hernia implants, the Symbotex is made of polyester rather than polypropylene plastic. The polyester in the Symbotex, however, has numerous defects of its own that can cause patients chronic pain and discomfort, and can lead to other medical complications. Hundreds of hernia mesh lawsuits have been filed because of these injuries, joining the Symbotex hernia mesh MDL, or multidistrict litigation.

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1. The Covidien Symbotex hernia mesh implant

The Covidien Symbotex is a medical device that can be implanted in a patient during a ventral hernia procedure. While the Symbotex can come in a variety of sizes and shapes, it always looks like a thick mesh with a biodegradable film of collagen on the backside.

The Symbotex was created to treat ventral hernias. A ventral hernia happens when intestinal tissue pushes through weakened muscles in the abdominal wall around the belly button. Some ventral hernias are incisional – they occur where a surgical incision was made in the past, weakening the muscles there.

Ventral hernias can be fixed through open surgery or with laparoscopic surgery. In laparoscopic surgery, the surgeon can make a much smaller incision and insert a laparoscope through it to access the hernia. Once the hernia is corrected, a Covidien Symbotex can be passed through the laparoscope and positioned on the abdominal wall over the hernia.

In open surgery, the Symbotex mesh is simply placed over the site of the hernia by the surgeon through an incision.

Once the mesh is in place and the incision closed, the polyester creates scar tissue on the weakened muscle. The scar tissue grows into the pores of the polyester mesh in the Symbotex, pulling the implant into the abdominal muscle. Supported by both the mesh and the additional scar tissue, the muscle can prevent future hernias from happening.

2. How to identify a Covidien Symbotex implant

There are dozens of models in the Covidien Symbotex line of implants that cover all of the shapes and sizes needed for ventral hernia repairs. With so many different options, there is only one unique trait that spans all of the Symbotex implants: A greenish marker in the center of the implant that looks like the location pin in Google Maps. This marker is added to the device to tell surgeons how to orient the implant.

Because identifying a particular model of Covidien Symbotex on sight is difficult, using product numbers is often easier. These numbers are based on the shape and size of the implant, as well as the procedure the implant is designed for1:

Procedure

Shape

Size

Product Number

Laparoscopic Ventral Repair

Oval

17 x 10 centimeters

SYM1710E

Laparoscopic Ventral Repair

Oval

20 x 12 centimeters

SYM2012E

Laparoscopic Ventral Repair

Oval

25 x 15 centimeters

SYM2515E

Laparoscopic Ventral Repair

Oval

34 x 20 centimeters

SYM3420E

Laparoscopic Ventral Repair

Oval

40 x 24 centimeters

SYM4024E

Laparoscopic Ventral Repair

Rectangle

15 x 10 centimeters

SYM1510

Laparoscopic Ventral Repair

Rectangle

20 x 15 centimeters

SYM2015

Laparoscopic Ventral Repair

Rectangle

25 x 20 centimeters

SYM2520

Laparoscopic Ventral Repair

Rectangle

30 x 20 centimeters

SYM3020

Laparoscopic Ventral Repair

Rectangle

37 x 28 centimeters

SYM3728

Laparoscopic Ventral Repair

Rectangle

42 x 32 centimeters

SYM4232

Laparoscopic Ventral Repair

Circular

9 centimeters

SYM9

Laparoscopic Ventral Repair

Circular

12 centimeters

SYM12

Laparoscopic Ventral Repair

Circular

15 centimeters

SYM15

Laparoscopic Ventral Repair

Circular

20 centimeters

SYM20

Open Ventral Repair

Rectangle

15 x 10 centimeters

SYM1510OS

Open Ventral Repair

Rectangle

20 x 15 centimeters

SYM2015OS

Open Ventral Repair

Rectangle

25 x 20 centimeters

SYM2520OS

Open Ventral Repair

Rectangle

30 x 20 centimeters

SYM3020OS

Open Ventral Repair

Circular

8 centimeters

SYM8OS

3. Why is the Covidien Symbotex defective?

The defects with the Covidien Symbotex hernia mesh implant stem from its use of polyester, rather than the plastic polypropylene.

Chronologically, the first defect in the Symbotex is dealt with by the surgeon conducting the hernia repair. Compared to polypropylene, polyester is limp, soft, and flexible. Getting polyester mesh to lie flat on the site of the hernia is far more difficult than it is to get polypropylene mesh to lie flat. Wrinkles, folds, or irregularities in the Symbotex mesh can all contribute to later complications.

The second defect is the inflammation that polyester creates, once implanted. While all implants are bound to create inflammation, those made of polyester create more inflammation than those made of other materials, including polypropylene.2 In addition to being painful, the increased inflammation can slow the healing process, lengthen the recovery time, and increase the risk of infection.

Yet another defect in the Symbotex is the fact that polyester shrinks and hardens after being implanted. As the polyester mesh shrinks, it pulls on the scar tissue that has grown into it, creating discomfort and chronic pain. The pain can be especially sharp if nerves have grown in the scar tissue, as well.

Worse, the shrinking polyester pulls on the sutures or metal pins that keep it in place. These sutures or pins are stronger than the polyester, so the contracting polyester does not pull them out – it simply tears. Once torn, the mesh can unravel, fold onto itself, clump together, or even pull entirely off the implant site and migrate elsewhere.

Even if the Symbotex implant stays in place, the outside edges can unravel and send threads of polyester migrating into the bloodstream. Because polyester creates more inflammation than most other implantable materials, wherever those threads land are likely to become inflamed, as well, creating a variety of potential problems.

4. No recall on the Covidien Symbotex, yet

In spite of the problems that the polyester in the Covidien Symbotex has caused, the device has not been recalled. Instead, victims and patients who have suffered from the Symbotex's defects have had to join hernia mesh MDLs and lawsuits to get the compensation they deserve.


References:

  1. Symbotex Composite Mesh Brochure, 2019.

  2. See Klosterhalfen B, Klinge U, Schumpelick V, Tietze L, “Polymers in hernia repair–common polyester vs. polypropylene surgical meshes,” Journal of Materials Science 35(19):4769-76 (October 2000).

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