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What is Medical Grade Silicone?

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  • Written By: John Markley
  • Edited By: Melissa Wiley
  • Last Modified Date: 02 November 2016
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Medical grade silicone is silicone with properties that allow it to be safely used in contact with living tissue, a characteristic called biocompatibility. Silicones are a group of synthetic polymers used in many medical devices due to their flexibility, heat resistance, and low toxicity and chemical reactivity. Medical grade silicone is used in medical devices such as bandages, feeding tubes, and medical implants. It can also be used in other products that come into close contact with the user, such as menstrual cups and barrier contraceptives.

All silicones are polymers with a backbone made from a chain of alternating silicon and oxygen atoms, with each silicon atom bonded to the oxygen atoms immediately before and after it in the chain and vice versa for each oxygen atom. Each silicon atom is also bonded to two organic side groups containing carbon, hydrogen, and in some cases other elements as well. Some silicone polymers have side groups and are able to bond with more than one silicon atom, creating even larger molecules composed of multiple linked chains. Silicones vary in their physical and chemical properties and in their suitability for medical use, according to their composition and structure.

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Biocompatibility is a material's ability to be used as part of a medical device without harmful effects on the patient. Many materials are unsuitable for medical use due to toxicity or chemical reactivity or because they trigger an immune response in the patient's body. A material's biocompatibility can vary according to application, as materials can affect different parts of the body in different ways. Medical grade silicone is manufactured in carefully controlled environments to prevent contamination with other materials that could compromise the biocompatibility of the final product.

In the United States of America, standards for medical products are established by an organization called the United States Pharmacopeia (USP), which publishes a yearly set of quality and purity standards of the same name. Many other countries also use USP standards, in whole or in part. Medical grade silicone generally refers to silicone classified as USP Class 5 or Class 6, meaning that it has undergone and passed a battery of tests intended to determine whether a substance with biological materials is safe enough to fulfill USP standards for medical use. These classifications by themselves are not proof that a silicone is appropriate for a particular medical application, as a medical device's biocompatibility is always relative to the type of tissues it interacts with.

Medical grade silicone is used for a variety of purposes in medicine. Silicone rubber, which is very flexible and easily shaped, is used for medical tubing in devices such as catheters and in seals. Many implanted medical devices contain silicone components, including pacemakers and artificial joints. Silicone is also used in cosmetic and reconstructive surgery.

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Lostnfound
Post 2

I guess silicone cooking utensils and similar are made of food grade silicone. I wonder if that's a higher grade silicone than medical grade?

I know the one scraper I have that's made from silicone and I wouldn't take anything for it. It's pretty much indestructible.

I also like silicone caulking for the bathtub. It's much longer lasting than regular caulking compound. It doesn't discolor, either, which is really nice. It also comes out much smoother than regular caulk.

I remember hearing about the lawsuits about the breast implants. Seems one of the companies had been using industrial grade silicone. Scary.

Grivusangel
Post 1

Medical grade silicone has been the subject of all the lawsuits concerning breast implants. Women have said the silicone leaked out into their breast tissues and caused terrible pain and other problems.

Seems like the investigation revealed that some of the companies that made the implants did not use medical grade silicone; it was a much lower grade that wasn't safe for implantation. I know some of those companies paid out huge amounts in damages because their implants failed, and they were using bad silicone, so these women really suffered. It’s one of those things that never should have happened.

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