Defective Surgical Mesh Complications

Many of the complications women have reported in connection to defective surgical mesh have been tied to claims that manufacturers may have rushed the medical device onto the market before adequate testing, data and studies could reveal possible injuries or negative side effects.

The History of Surgical and Transvaginal Mesh

By 1970, surgical mesh became an option available to doctors in their efforts to treat pelvic organ prolapse and stress urinary incontinence, in addition to other conditions where the bladder, uterus or bowels drop. As an answer to the painful conditions, doctors began inserting surgical mesh as a reinforcement, in order to hold up dropping organs. It was not until decades later that doctors began inserting the mesh through the vagina.

Ethicon Gynecare Prolift Mesh

Manufactured by Johnson & Johnson, which has struggled with recalls and complications related to other medical devices and drugs, Prolift Mesh endured warnings by the Food and Drug Administration as early as 2008. By 2012, Johnson & Johnson discontinued sales of defective surgical mesh, though they asked the FDA for permission to continue sales of mesh that is inserted through the abdomen, discontinuing distribution of defective surgical mesh inserted vaginally. Other types of surgical mesh that the medical device giant plans to discontinue, include:

  • Gynecare Prosima
  • Gynecare Prolift+ M Mesh
  • Gynecare TVT Secur

According to the FDA, the company hopes to halt sales, pulling the products from the market by 2013. Despite the hundreds of complaints tied to defective surgical mesh, the medical device manufacturer claims its decision to pull the products is not tied to poor safety. Instead, they claim the mesh is being pulled as a result of a changing medical device climate and transforming needs and technology.

What Went Wrong?

Thousands of reports of complications began pouring in to the Food and Drug Administration between 2008 and 2010, garnering attention from the Administration and from health and safety advocates. As a result of the complaints, the FDA issued a warning to consumers, questioning whether the risk of adherence to other organs, painful intercourse and danger of re-occurrence of problems leading to the initial surgery.

Comments are closed.