Covidien Ltd. gained FDA approval of its first hernia mesh in 1999. Recently, (FDA). Covidien offers multiple models and variations of its hernia mesh to patients and each has been linked to complications and injuries.
If you had a hernia repair surgery and Parietex hernia mesh was used, you may have suffered complications from your surgery which could entitle you to financial compensation.
The personal injury attorneys at the Shouse Law Group are here to represent injured clients and inform you about the risk and complications associated with Covidien products.
- 1. What is hernia mesh?
- 2. What is Parietex hernia mesh?
- 2.1 What is it made of?
- 2.2 What are the different versions of Parietex hernia mesh?
- 3. How were Parietex hernia mesh models approved by the FDA?
- 4. Are there any side effects or complications?
- 4.1 What is chronic pain?
- 4.2 What is adhesion?
- 4.3 What is a seroma?
- 4.4 Can I get an infection from Parietex hernia mesh?
- 4.5 What is bowel perforation?
- 5. What do I do if I was injured by Parietex hernia mesh?
Hernia mesh is a screen-like medical mesh which provides support to damaged and weakened tissue caused by a hernia. A hernia is a bulging of an organ or tissue through an abnormal opening.
Hernia mesh is intended to prevent the re-occurrence of your hernia. Defective hernia mesh leads to thousands of patients suffering complications every year. There are many types and classifications of hernia mesh which a surgeon may use, each with its own benefits and complications.
Parietex is a group of hernia mesh products sold by Covidien to surgeons and hospitals for patient use. It is designed for the treatment and support of hernias.
There are different types and classifications of hernia mesh according to function and composition. Many Parietex products are made from polyester, with a variety of coatings and other materials included depending on the specific model. Polyester is not as firm or supportive as other materials and has been known to cause more severe inflammation in patients.
Some studies have shown that synthetic meshes are more likely to result in complications after hernia mesh surgery, and reports have indicated that polyester mesh such as Parietex products is even more likely to create problems for the patient. 1
Over the years, the FDA has approved several different hernia mesh products from Covidien. In your surgery, one of these more common models may have been used:
- Parietex Composite Ventral Patch: A smaller patch designed for hernia repair of the abdominal wall.
- Parietex ProGrip Self-Fixating Mesh: This model has "micro grips" meant to combine mesh and fixation into one to eliminate pain associated with tack fixation.
- Parietex Optimized Composite Mesh: This mesh uses a large number of tacks for fixation, which is known to cause higher levels and duration of pain in patients. It has large pores (holes in the material) which have been shown to lead to infection.
- Parietex Plug and Patch System: With this product, a surgeon must place the mesh correctly on the very first try, or it is ineffective. It is known to have high infections rates. An infection requires removal of the product.
- Parietex Composite Open Skirt Mesh: Mesh which is designed for hernia and incision repair. Known for causing infections in patients.
- Parietex Optimized Open Skirt Mesh: Marketed as more resistant to damage than Covidien's "Composite" meshes.
- Parietex Composite Parastomal Mesh: A mesh with unsealed edges which can unravel and tear.
- Parietex Lightweight Monofilament Mesh: This mesh is designed to be lighter weight than other Covidien products.
Covidien manufactures many different models of hernia mesh, including those listed here. Each has been associated with complications and reports to the FDA. 2
Parietex was approved by the FDA through the 510(K) Premarket Approval Program. This means that these models of hernia mesh did not go through rigorous medical testing to determine whether they were effective or safe. Covidien was only required to demonstrate that Parietex products were as safe and effective as similar devices on the market. 3
This program is highly criticized and has allowed defective mesh models to enter the market and be used on patients.
There are many different side effects and complications which can result from a doctor's use of defective Parietex products or from the doctor's own negligence. These complications can be minor and short-lived to severe and long-lasting.
Pain after surgery for a short period is normal as your body heals. Severe pain or pain which lasts for longer than three months (chronic pain) is not normal and may be caused by defective Parietex hernia mesh.
Parietex hernia mesh is known to cause adhesion, which occurs when scar tissue forms around the mesh implant and joins the implant with other internal tissue or organs. This can occur within a few weeks of your surgery, or it can occur over a much longer period of time.
Adhesion typically occurs after the absorbable coating on the Parietex hernia has worn off, leading to serious consequences such as bowel obstruction and severe pain. 4
A seroma is a collection of fluid, called serum, that builds up under the surface of the skin. They can develop where surgical incisions were made in the body or where bodily tissue was removed. These commonly occur after a significant surgical procedure such as a hernia repair and can be the result of defective hernia mesh.
Many patients develop infections after surgery with Parietex hernia mesh. This can be caused by an allergic reaction to the polyester mesh or malpractice by your surgeon. Infections can be serious, causing you pain and causing delays to your healing process.
Parietex models are also known to have unsealed edges which can cause bowel perforation. Perforation of organs such as your bowel is extremely serious, leading to severe pain, infection, and long-term complications.
If you or someone you know has been harmed by a doctor, nurse, or other healthcare provider's negligence or by defective hernia mesh, contact our personal injury lawyers about filing a lawsuit for injuries due to hernia mesh surgery. Call us at 855-396-0370 or fill out our online contact form on this page.
- NCBI. Which mesh for hernia repair?
- Covidien. Product Catalog.
- FDA. Premarket Notification 510(K)
- Schreinemacher MH, Emans PJ, Gijbeis MJ, Beets GL, Bouvy ND. “Degradation of mesh coatings and intraperitoneal adhesion formation in an experimental model.” Br J Surg. 2009 Mar;96(3):305-13. doi: 10.1002/bjs.6446.