Posts tagged piercing jewelry

Point 86: Biomaterials & Trustworthy Sources

Comments Off on Point 86: Biomaterials & Trustworthy Sources read Features, Issue 86, Science & Body Modifications

Why materials from countries without strict quality control requirements are unacceptable for jewelry

by Brian W. Skellie, APP Medical Director

Does it matter where a biomaterial we use comes from?

Biomaterials made in the USA and in a short list of countries who maintain reciprocal quality control agreements can currently be verified as ASTM or ISO compliant. Those materials made outside of these qualifying countries cannot due to a lack of quality control protocols and lack of consequences for substandard and falsified products. The provenance of the material should be listed on the certificate of tests.

Is knowing the chemistry enough?

Learning what the ingredients are, as well  as the proportions of a material, is a minimum step in the right direction to indicate that it does contain what we need, and does not contain harmful impurities over a certain threshold. Chemical tests are not confirmation of quality by themselves. The only way to be sure about the quality of the material is to have reliable chemical and microstructure tests performed under strictly regulated controls during the final purification melt and on the ingot (block of metal) produced, prior to forming it into bar, wire, sheet, etc. We must be assured that the correct ingredients have been mixed and cooked together in the correct way, and that the material has been treated and handled correctly during the process according to the ASTM and ISO specifications. There is more to the ASTM and ISO standards than chemistry. So if a certificate says “chemistry only” the material has not been fully tested to fulfill the material properties required by the standard, and may break or include foreign matter among other disadvantages. Basically, we want the raw materials to fully meet the standards for surgical implant, and we want documented proof that it was tested and completely fulfills all the requirements during the melting of the alloy. No misleading shortcuts. No half-steps. Add a proper surface finish, cleaning, passivation, and sterilization and then we can wear it with a clear conscience.

Currently, our requirements for gold, niobium, and platinum are measured based on chemistry alone. We have a strong theoretical rationale to use them based on the fact that they are three of the most biocompatible elements and have a longstanding history of acceptable level of response in the body. Unfortunately, they are not as strong when compared to other biomaterials, and do not have the same sort of detailed specifications for use in the body. For gold and platinum, because of proprietary alloys and strict legal regulation for the karat content, the chemical analysis is all we have access to if we don’t use gold or platinum group metal alloys that have already been through ISO 10993 testing for biocompatibility. Gold and platinum group metals are frequently mentioned in biomaterials and dental implant science texts as inert substances with low potential for allergy

“CORROSION AND CORROSION CONTROL IN THE BIOLOGICAL ENVIRONMENT

“The need to ensure minimal corrosion has been the major determining factor in the selection of metals and alloys for use in the body. Two broad approaches have been adopted. The first has involved the use of noble metals, that is, those metals and their alloys for which the electrochemical series indicates excellent corrosion resistance. Examples are gold, silver, and the platinum group of metals. Because of cost and relatively poor mechanical properties, these are not used for major structural applications, although it should be noted that gold and its alloys are extensively used in dentistry; silver is sometimes used for its antibacterial activity; and platinum-group metals (Pt, Pd, Ir, Rh) are used in electrodes.”

1 Biomaterials science: an introduction to materials in medicine, Buddy D. Ratner https://books.google.com/books?id=Uzmrq7LO7loC  page 434

For this reason, and historical antecedents we feel comfortable with some gold alloys for initial piercing jewelry. Most of our evidence related to gold for use in jewelry is based upon historical, that is to say experiential and anecdotal sources. Gold has been used in jewelry fabrication since prehistoric times, and has had a similar length of history in surgical and dental applications.

Gold implants are used in various medical procedures, including reconstructive surgery of the middle ear, upper lid closure in facial nerve paresis-induced lagophthalmos, drug delivery microchips, antitumor treatment, treatment of rheumatoid arthritis, use on the surface of voice prostheses, and endovascular stents, with sound clinical results.

2 Demann, Eric TK, Pamela S. Stein, and James E. Haubenreich. “Gold as an implant in medicine and dentistry.” Journal of long-term effects of medical implants 15.6 (2005). https://www.ncbi.nlm.nih.gov/pubmed/16393135

Who should understand our jewelry standards?

Our standards are necessary for jewelers and regulators as well as piercers, healthcare professionals, and the public. APP publications have previously addressed the general public as the primary audience for our jewelry standards. Our simplified explanation of the rationale for our jewelry standards is helpful for clients, but not specific enough for regulators, and missing information for jewelers. We have chosen to rely firmly upon specifications that have been pulled from medical and dental implant sciences, and voted to allow to permit the use of certain traditional jewelry materials that are composed of biocompatible elements which seem to demonstrate an acceptable response in the body. This represents two categories of materials: specified and agreed upon.

The specified biomaterials are exact standards for materials that can be purchased ready to use for making body jewelry based on evidence that meets CDC recommendation Category IA: Strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies.

This would include all biomaterials which have been developed using ASTM and ISO standard specifications for implantation.

The agreed upon materials of gold and platinum alloys, niobium, and fused quartz, soda lime, and borosilicate glass are within the ideal of CDC recommendation Category II: Suggested for implementation and supported by suggestive clinical or epidemiologic studies or by a theoretical rationale. For example, there is strong evidence that the pure elemental form of each of these materials are well accepted by the body, and they should retain that quality when alloyed until a threshold level of sensitizing or toxic elements are added to the mix. ASTM F2999 and F2923 limit the harmful levels of toxins based on California Prop 65.

Why are material standards important to understand?

Our standards are based on utility rather than our own invention. We use existing medical and dental expertise for materials that are currently being used in human implants and prosthesis. We rely upon a body of evidence and experimentation that we as an industry have not yet become capable of doing ourselves. For this reason, it is important for us to find and understand reliable information from other fields that can be applied to our own.

Why is the language we use important to describe standards to the public, jewelers, and regulatory authorities?

Simple descriptions should be clear for the biomaterials we choose for body jewelry. Existing materials which are made to ASTM and ISO implant specifications are tested according to consensus based scientific standards to ensure long term safety in the body. We choose these material specifications to avoid reinventing the wheel, and the ISO 10993 series of tests for those new wheels can be prohibitively expensive. We use the specifications F67, F136, F138, F1295 etc as a summation of what we need for safe materials, before they are formed into jewelry. We should not have to elaborate the minutiae of these specifications to know that they are applicable and achievable for our purposes. Can get away with less precision? Not without introducing high levels of risk.

Understanding biomaterials is one of my goals as both an experienced professional piercer and long time member of ASTM Committee F04 on Medical and Surgical Materials and Devices. I hope that some of the information we have to share is helpful to you.

Footnotes:

1 Biomaterials Science: an Introduction to Materials in Medicine, Buddy D. Ratner http://books.google.com/books?id=Uzmrq7LO7loC page 434

2 Demann, Eric TK, Pamela S. Stein, and James E. Haubenreich. “Gold as an implant in medicine and dentistry.” Journal of long-term effects of medical implants 15.6 (2005). https://www.ncbi.nlm.nih.gov/pubmed/16393135

Point 76: Tether – Creative Innovator Award & Best Single Booth

1 Comment read Awards & Recognition, Conference, Issue 76, Questions & Answers
The Point: Issue 76 - Cover

Kendra Jane: Tether Jewelry had a very strong first show at this year’s expo. Tell us how it came to be and what the line is all about?

Tether Jewelry: Tether is about creating a jewelry brand that is not only innovative and beautiful, but can reach a wide audience. Riding that line between where designs can be enjoyed and embraced by all people. No matter gender/scene/age, jewelry for all. With each piece of jewelry we hope to take you on a journey; our story is just beginning. That is why this season is called Genesis.

Spending 15 years at a very jewelry-centric studio was where I truly fell in love with body jewelry and all it’s diversity. I started asking “why isn’t anyone making this/doing this better?”

It was at that time I was blessed with the job of designing a line for the shop, I got my first taste as a jewelry designer, and began to bring answers to that question. During that time it really inspired me to explore my designing capability further.

It was 3 years ago, at the 2013 Conference that I decided I wanted to finally pull the trigger on starting my very own jewelry line. The following year was tough; I kept running into obstacles and other frustrations. All while continuing to pierce. I finally decided to take a huge leap of faith and step away from piercing last year to give Tether all my energy. Fast forward to now, after an amazing response at the Expo. It feels so good to have overcome those roadblocks and have reassurance that the leap of faith I took was worth it. The future looks very bright and I’m excited to continue in this industry I love so very much as a jewelry designer and manufacturer.

Kendra Jane: How did you come up with the name of your company?

Tether Jewelry: Naming things/projects is the hardest thing for me. My brain can’t seem to commit to one idea. But there was something very natural and easy when “Tether” popped into my head. The name comes from a place of feeling anchored and connected to things. Being a social shapeshifter myself, I like to be fluid and sit in between two social scenes or two places, taking inspiration from different places and surrounding myself with many peer groups. Tether comes from that place too. There is something uniting and comfortable about that flexibility.Tether Jewelry display

Kendra Jane: This year Tether took home not only the Innovator’s Creative Award but also the Best Single Booth Award, what was the inspiration behind the design of your booth?

Tether Jewelry: I wanted to bring the feeling and identity of Tether out and present all my products in a striking yet minimal environment. We wanted to create a visual experience that was uniquely Tether. We arranged our jewelry display in a way that made you feel like you were looking at an alien language, and as our guest, to feel like you’re a space explorer that just stepped into another world.

Kendra Jane: The design of your booth was unique, but everything about your presentation is very well thought out, right down to your packaging. Tell us more about this.

Tether Jewelry: It took over 2 years to come up with a more complete system for the line. Tether isn’t just about the jewelry. It’s a true exploration of those great feelings you get from adornment and fashion. When you open a box and it contains something that when you put into your hands, or put on, it gives you joy. You get a smile, smirk, or goosebumps. I know we all have felt it. This is my compass in my journey as a designer.

Everything has been designed together and iterated many times. Every color we use is deliberate: our displays, the font, our images on social media, all of it.

There is a quote that has always rang true for me from Doug Tompkins who founded a successful outdoor line: “There is no such thing as small details.”

I also say “we” because all of this wouldn’t have happened without the team of artists/designers and dreamers that are part of Tether. And, of course, to our wearers. Tether is about building something bigger than myself and trusting collaborations and making long term, deeper connections to bring forward something truly special. I hope people can feel that.Tether clicker display

Kendra Jane: Each one of your pieces has a name and a story, please tell us what some of them are?

Tether Jewelry: The 2017 Collection was named Genesis as it marks the beginning of our journey. Our first experiment to glimpse into a future unknown. It’s inspired by water and crafts of travel; both space and sea. Also comes from a passion for machines, science fiction and architecture. Some of the designs were brilliant accidents.

• Navigator — The very first locket ear weight. The name came from the movie Flight of the Navigator. I adored that movie as a kid. The shape of this design was inspired by the spaceship in the movie and a traditional gold ear weight from the Tamil Nadu region of India. This is my ode to alien spacecrafts that can travel our deep blue seas as well as the vast expanse of space.

• Melange — Inspired by the distinctive work of H.R. Giger, I wanted to create a piece to have depth, and texture, but from more angles. It’s my own take on gold granulation, stacking together long tubular ellipsoids to create patterns.

• Drake Series — The Genesis collection is inspired by ocean and water. One of the most well known civilizations that had their own innovations on the sea were the Vikings. The longships were way ahead of their time. And so this design is an ode to one of their ships. The Drake name comes from the word Draken which means dragon. The Vikings sometimes had a dragon-shaped prow on their longships as a symbol for protection. Out of that design, using the curving lines of a Viking longship keel, manifested the Drake cuff. The Drake hoop was an accident from an early iteration of the cuff that was too large, I immediately thought how a larger clicker weight would be great in earlobes.

Kendra Jane: What are your plans for the next year?

Tether Jewelry: You can expect more designs next year. I am committed to ensure we are delivering the best product to the end customer. Our primary goal for next year is how to be a better wholesale-only design house. All the while enjoying ourselves and trying to create a memorable and lasting experience.

Kendra Jane: Do you have any advice to those small companies that are thinking about making their first appearance on the Expo floor at Conference?

Tether Jewelry: This took a huge leap of faith for me. Plan for the long game, there are no shortcuts. This industry is growing fast and there is a little piece for all of us. Don’t be afraid to partner with someone. We can’t do everything ourselves, especially when doing it well.

Tether Jewelry - 2016 APP Expo Booth