Which law is applicable to sell the hernia mesh as a medical device in Latin American countries?
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Hernia mesh is a product which is used in hernia repair. It is made from implant-grade plastics which are formed into a grid which can be used at the site of a hernia to hold herniated organs in place and provide a lattice for new tissue to grow on, effecting a long term repair at the site. This product is not used in all hernia repair surgeries, but it is very common, and there are a variety of types and styles available for surgeons to choose from.
Hernias occur when body organs protrude through the connective tissue which normally protects them and keeps them in place. This creates a distinctive bulge, and it can lead to complications such as death of the herniated tissue. The most common type of hernia is an abdominal hernia, in which the intestines or pads of fatty tissue protrude through the abdominal wall. In most cases, a hernia must be corrected with surgery.
Historically, hernia repair was accomplished by pushing the herniated organs back into place, and sewing the weakened tissue back together so that the organs could not protrude. However, this type of repair was vulnerable to recurrence, since the surgery created a weak spot. When a hernia mesh is applied, the mesh covers the weak area, sort of like a tire patch, and it is sutured in place. The mesh holds back the organs while the area heals, and promotes the growth of new connective tissue across the mesh to reduce the risk of recurrence.
The hernia mesh is designed to be left at the site. In some cases, the mesh remains intact, while in other instances, it may bioabsorb, breaking down over time as the site heals just like absorbable stitches do. Hernia mesh is non-reactive, and it should not cause infections, the development of allergies, or other complications. The surgeon chooses a mesh which best fits a client's case and the surgeon's experience, and many meshes can be cut to size for specific applications.
On occasion, a hernia mesh may fail, or be poorly designed. Some companies have issued recalls of their products, indicating that surgeons should remove their defective meshes before they cause complications. When a recall is issued, information is sent to the surgeons who use that company's products, and the surgeons are expected to notify patients. Patients may want to ask about the specific brand and style of hernia mesh used in their hernia repair at the time of a surgery, so that if a recall is issued and their surgeon cannot contact them, they can use the services of another surgeon to address the recall.