Wikipedia "Body Piercing Materials" article review by Westley Wood
review questions the legitimacy of the assertions in
Wikipedia under the title "Body Piercing Materials"
claims that "only steel that is certified to meet ASTM
F138 or ISO standards for surgical implant
applications" (should be, and is designed to be
thought of as) "is" the standard body piercing stainless
steel material. I will show by expert and authoritative
references that this claim
is presumptuous, without merit, cannot be defended, and
rejected. Among other references, I will clearly show by
direct reference to the testimony of ASTM, that the safe
use of non-certified 316L in millions of piercings for
the last twenty years proves that non-certified 316L is
safe, that the sheer volume of
safe use of
non-certified 316L proves beyond a shadow of a doubt
that 316L is indeed the standard in the
U.S., as well it should be, and not the "hardly-used" 316LVM.
The article in Wikipedia claims that the standards (APP) are based on (unspecified) research and (unknown) historical experience of APP. However, in review of authoritative metallurgical literature on stainless steels, bibliography provided at the end of this article, no support can be found in any way for switching to certified F-138 for body piercing jewelry, nor is anything relevant found in readings on biomaterials, besides the outright violation of the principles of ASM standards. The inescapable conclusion is that F138 is not be a rational choice as the standard for body piercing jewelry. There is no merit to the assertions in the article appearing in Wikipedia.
Here are the key arguments to support the continued use of non-certified 316L and opposition to advocating a (compulsory) change to F138 316LVM.
It is not irrelevant to point out that APP-member body jewelry suppliers are the staunch defenders of the superiority of 316LVM and have made a career of selling body jewelry made of this advanced alloy.
1. F-138 is a standard created and published by ASTM, a standards-making body that meets the criteria of a "standards-making" body. APP does not. The views expressed in this article are advocacy and must be rejected.
The article uses ASTM without understanding, and in contradiction of the core fundamentals of ASTM.
From: www.ASTM.org, ANSI
National Standards Strategy for the United States
Successful standards processes yield the right results.
Standards are performance-based, specifying essential characteristics rather than detailed designs.
This principle is contradicted by APP.
Specifying a particular product, in this case F138 316LVM or a narrow range of products rather than the essential characteristics of materials suitable for use violates this core principle of standards-selection required by ASTM-ANSI (as well as contrary to OSHA, and AAMI standards-setting principles). There are other stainless steel alloys suitable for use besides those certified to F-138 standards (and I maintain 316L is the perfect refutation). According to ASTM, even if there were no other competing suitable products, teh standard would never stipulate the one product, but rather the regulation would specify the essential characteristics the material must have for a specific application. This alone is sufficient to abandon this article as false.
Let me illustrate:
For example, suppose we want to write a regulation to enforce the principle that contaminated surfaces must be disinfected. It would not be acceptable to require the use of a particular disinfectant by name, such as, everyone must use "Madacide". Even if Madacide were the only product available at the time, it still would not be named, but rather, essential characteristics of performance would be written that "products" should be selected that are able to decontaminate a hard surface in a safe and effective manner, etc., etc..
Why? ASTM is clear. Specifying a particular product (a detailed design) might rule out even better products, or ones under development, or may prevent new technology from being introduced. Not only that drawback, but naming a particular product would prevent the flexibility to respond in new, novel or a better way under unique circumstances, not all circumstances can be imagined at the time of writing the regulation.
ASTM also considers that the selection of a product is best done locally by those most familiar with the local needs. Therefore, a properly written standard for material-selection would read something like this: a stainless steel or other material that has proven itself over time, and, by use has been shown to be safe and effective, etc..
This article is without merit.
2. ASTM requires that standards must be relevant to the needs of the application. In this case, an increase to a "higher(?)" standard, to F138 are not relevant to body piercing jewelry applications and offer no value above 316L that would be beneficially prudent.
F138 certified 316L material is a unique SS (based on non-F138 certified 316L) made to increase the functionality, safety, and life-span of implants (in specific applications) as bonded with the human body in the treatment of medical problems. These properties are of no value for body piercings.
Attempting to dis-allow non-F138 certified 316L by requiring the use of certified F138-316LVM (manufactured by APP supporting businesses), is like claiming passenger cars capable of speeds of 500 hundred miles per hour are better than currently used cars and should replace them. Just as passenger cars have no road or place to achieve those speeds, so too, the improved characteristics that make F138-316 better for implants, for wires, screws and other medical devices within the body cannot be called into play to enhance the performance of a body jewelry application. The claims in Wikipedia apparently have no reference to the interaction of implants and the body, otherwise they would have seen the specious nature of their claims.
The ASTM position is: Standards must be shown to provide relevant value for the application.
To illustrate the violation of standards-setting by APP, consider if it would be relevant to require body jewelry to be made of material that would increase its melting temperature from one thousand to two thousand degrees on the argument that more is better, or it wouldn't hurt. There would be no justification, no rationale for that "improved" characteristic for body jewelry use.
Requiring F138 certification for body piercing jewelry application has no merit. Consider another example: we may want a car that will start in freezing weather but it would not be relevant to legislate in law that all cars must be able to start in one hundred degrees below zero weather. It would not be a relevant accessory: car usage is not user-improved.
There are more reasons why replacing non-certified 316L with F138 ( read 316LVM suppliers) is an advocacy position, not a relevant standard.
The intentionally developed characteristics that make F138-316LVM improved for implants inside the body are not relevant for body piercing jewelry outside the body. For example, body jewelry does not have to be free of ferrites which can lead to implant failure when placed inside the body. Body jewelry progressively cracking is unheard of caused by the forces of cyclical bending and load-bearing in a bio-active corrosive environment for metals. This characteristic improvement is not relevant to body jewelry separated from and not bonded with tissue.
Let's look at another reason this APP position has no merit.
Stainless steel body jewelry is primarily concerned with corrosion resistance of the surface.
Biomaterials interact with the body through their surfaces. Consequently, the properties of the outermost layers of a material are critically important in determining both biological responses to implants and material responses to the physiological environment. (ITBI 2002:149)
"Only surface modifications are needed, because biological tissues interact with mainly the outermost atomic layers of a biomaterial." ( ITBI, 2002:166)That's the whole ball of wax, so-to-speak. What is underneath the surface of body jewelry, the bulk, is responsible for improved strength, when being bent or twisted, for example, which would be ludicrous to consider for body jewelry application. The surface is the issue for body jewelry and in this case 316L material self-repairs in the presence of oxygen as well as 316LVM.
316L stainless steel is "stainless" because it contains a sufficient amount of chromium that when the surface of the item is exposed to oxygen (in the air primarily for body jewelry), the oxygen combines with chromium forming a passive layer on the surface making it resistant to corrosion and deterioration. This is the characteristic which is proven by use to be effective to protect body piercing jewelry from corrosion. There is no corrosion problem with the non-F138 certified 316L body jewelry actually used by tens of thousands of tattooists on a daily basis. The Wikipedia article is false.
3. ASTM emphasizes that the history of usage is the most important determinant for choosing materials for implants. Though ASTM and metallurgical literature never address how to choose a particular stainless steel for body piercing jewelry, non-F-138 compliant 316L material has been safely used for 20 years in millions of piercings, by tens of thousands of piercers without any evidence of corrosion or fatigue.
It violates ASTM standards to retired or replace a product unless significant advantages are achieved by so doing. There are no advantages other than to alter market share to increase the sale of 316LVM body jewelry. By continuous use of non-F138 SS, day to day, year to year, body piercing users and practitioners reject the F-138 argument because experience proves 316L safe and affordable. Why would APP advocate a change to a different bulk material?
The verifiable historical experience of the body piercing industry in the U.S. stands in contrast to the claims of this article and categorically puts the stamp of approval on non-certified 316L as the safe stainless steel of choice.
Because non-certified 316L is proven safe, effective, and economical in vivo, opponents must prove non-F138 316L is harmful or dangerous. Arguing that F-138 certified 316LVM is purer or stronger, or more corrosion resistant, or is the alloy of choice for orthopedic joint implants must be shown to be relevant. Where is the evidence of the failures of 316L in vivo. Where are the cases documenting the shedding of cobalt, chromium and other metal particles into surrounding tissues? There is no doubt this article is advocacy and without merit.
In their Introduction to Stainless Steels, Beddoes and Parr describe how to select a stainless steel.
A fair approach, if one is basing a choice on previous experience, is to ask in what ways the material was deficient or, if not deficient, in what ways performance could be improved by a different selection. (ISS:19)
And so the question is: in what ways is non-certified 316L deficient or unacceptable in performance that it should be replaced by ASTM certified F138 (i.e., 316LVM). What advantages will clients and body piercers have that justifies the added expense and disruption of the flow of materials and products.
4. The ASTM organization requires that to be a standards-setting body, standards must achieve a consensus of all those affected by the standards in an open and transparent manner. An organization acting without consensus, without scrutiny, without debate, and without consulting those affected, would not be recognized as legitimate, especially trying to impose their unique choice of material on the body piercing industry.
Instead of open debate, articles appear, such as the article in Wikipedia, in an end-run, in hopes that others will assume that the standards are legitimate because they are in print. After all, Wikipedia is prestigious.
Besides these arguments, there are other reasons to call for rejection of the Wikipedia article.
For example, the opening paragraph is unsettling for several reasons.
First, the statement promotes the EU model of considering body piercing jewelry, medical products. The U.S. considers body piercing jewelry as cosmetic, not requiring medical device clearance. The FDA system is not deficient, or lagging behind other countries. Different yes, but not what APP apparently wants.
Certain countries, such as those belonging to the EU, have legal regulations specifying which materials can be used in new piercings. (Wikipedia sourced 5/19/2011)
This seems to be a faux pas, because a troubling bit of information is being withheld: the EU requires titanium and prohibits stainless steels for new piercings. If readers knew this, it would throw the entire article into disarray, pandemonium, inviting scrutiny and expecting an explanation for the disparity. If the EU requires titanium how is the EU wrong and APP is right in advocating for 316LVM and yet praising EU choice? Does this mean APP may want titanium to be the standard?
The suggested answer to that question is old, which is, sometimes regulations are crafted to favor members and exclude others. For the EU, they produce titanium product (China must import titanium from the EU), and F-138 316 LVM and titanium body jewelry are specialties of APP member companies.
Secondly, another "missing" fact: the State of California created legal regulations for body piercing materials following the "Lead crisis" when a group of lawyers brought suit charging that consumers were not being warned of the presence of lead and other toxic chemicals, especially in children's' jewelry. Body jewelry was also investigated. Unimax Supply Co tested their body piercing jewelry and found all samples of 316L within "Safe Harbor Levels" meeting the newly created Class A requirements for use in initial body piercing.
In creating Class A requirements for initial piercing, the State of California followed the principles of standards-setting bodies by not specifying any particular product, such as F138 steels (read: 316LVM), but allowing the generic category of unspecified implant grade stainless steel as safe and appropriate for initial piercing use. This principle allows users the freedom to choose among a range of materials which would include LVM, new types that will be developed in the future, and of course affordable non-F138 316L.
California could have been a little more exact by stipulating stainless steel and other materials shown to be safe and effective for consumers and practitioners. That would have dotted the "i"s.
The quote above, from the Wikipedia article, is not just a random piece of information but also hints the author has a Functionalist-statist view that governments should make laws to permit actions as well as prohibit actions, a very different view than what makes the U.S. political system different.
Another observation is that the article is self-contradictory because, on the one hand it rests on ASTM-originated voluntary consensus standard F-138, and on the other hand calls for government to make it non-voluntary and immutable. The shame of that is, that once in place it becomes very difficult to change, making technological advancement impossible. The article in Wikipedia is advocacy, not reality.
The "safety standards" sentence in Wikipedia reads:
Minimum Standards for Jewelry for Initial Piercings
First -- To review: It is simple to discover that this statement is empty rhetoric. 316L (without the LVM) earned its position as the de facto benchmark standard, precisely by its safe use in the millions and millions of piercings by the tens of thousands of piercers in the U.S. and elsewhere over the last 20 years. This is the undeniable, incontrovertible historical experience of the U.S. which can be verified by calling around to tattoo shops that do piercing and by looking at the offerings and sales of the major suppliers to the trade. Unimax Supply Co is a major player and sells millions of pieces of non F138 certified 316L compared to a handful of LVM. The safe use of 316L is based on the nature of stainless steel in a body piercing whereas APP standards are based on standards for surgically implanted medical devices used for joint replacements and orthopedic implants. Their choice and reasoning has no merit for body piercing because the requirements for joint implant material is not relevant for body jewelry.
Second - From what is known generally of APP over the years, I don't recall them claiming to be an authority on body piercing. The errors exposed here clearly show they are not, and must submit their arguments for public scrutiny, not formulate them behind closed doors for their own agenda. Assertions require proof in an open and transparent debate. They can advocate and believe anything they want, force their members to agree, embrace their own unique standards, advocate for them, promote them in magazines but they should correct the record by admitting they are an advocacy group and the information contained in Wikipedia is their opinion, without consensus from those to be affected.
Third - Another claim is made in the Wikipedia article that is also without merit or argument or proof
Minimum Standard for Jewelry Threading for Initial Piercings:
There is no evidence that internally threaded jewelry is safer than externally threaded jewelry. Internal tapping fails the historical use-test as well.
Actually withheld from the reader is that the widespread safe and effective use proves externally threaded jewelry is the benchmark standard. APP member fabricators specialize in making and promoting internally threaded jewelry. They claim externally threaded jewelry tears up the inside of a piercing when the jewelry is inserted, that clients wince in pain and agony. Only they seem to have these reactions. This specious argument contradicts the millions of piercings done annually and is false. There is no truth to the assertions.
Fourth - F138 certification is an "over-the-top" specification without any increase in benefits for body piercing practitioners or clients. (Read 316LVM) is a choice, but without merit for body piercing, certainly not cost effective when a lower cost item serves the use perfectly well. Non-certified 316L, as currently and historically used, is the Best Choice.
Fifth - The placement of this article in Wikipedia seems strategic if F138-advocates are trying to find friendly health departments who will use this article as a reference for specifying APP's "approved" F-138 specification (316LVM), (displacing and prohibiting regular 316L). No doubt some health department will be unfamiliar with the issues or the facts and make a mistake referencing APP's unique standards.
Sixth - Another unsupported advocacy position should be mentioned.
Minimum Standards for Jewelry Surface Finish for Initial Piercings:
A consistent mirror finish is an extreme standard developed to prevent corrosion within the chemically harsh body to delay cracking and failure of an implant. All implants have a limited life span and eventually fail because of the environment.
Body piercings are not inside body cavities joined and interacting with the surrounding tissues, subjected to the harsh environment and so do not require the types of finishes and formulation standards that were developed specifically to lessen the problems implants cause within the body.
The literature is very clear why certain characteristics are needed for materials implanted into the body. Body piercings in fact reside outside the body, not integral nor functioning in the body as contrasted to implants. Every book accessed on the subject says the same thing, outlining the extreme conditions that implants require and the search for better and better products. The biomaterial community would never specify one particular standard so it is a dereliction for any organization to make such a stipulation attempting to impose their private agenda on the entire country.
Seventh - The article in Wikipedia is an advertisement designed and written to look like an information piece.
Eighth - The way to choose materials is by first examining what the requirements are, based on use, and then looking for the materials that meet those needs. It is disingenuous to look for reasons to defend and support F138 after declaring it the standard. Earlier versions of the Wikipedia article only sourced their own writings.
Ninth - To avoid any ambiguity, it should be made clear that surgically implanting materials is not an activity endorsed or promoted for body piercers. Implants are surgical procedures.
Tenth - The article is based on a fog, hiding a false-premise underlying the advocacy for F138 (hidden from the reader is a better guess - based on the previous example) that the environmental hazards for implants and body piercing jewelry are not the same. The literature on biomaterials is all about the development of materials that can survive in a bio-active, mechanically and physically stressed environment which is a world apart from the properties required for a belly ring that is effectively outside and separate from the body. A belly ring is not integrated into the structure or function of the body but exists independent of the body in an air-exposed atmosphere. Implants exist integrated into specific functions as part of the body.
Lastly - The following quote from the Wikipedia is problematic as well.
The only quality recommended for use by the APP is steel that is certified to meet ASTM or ISO standards for surgical implant applications. "Surgical Steel is made of a variety of alloys. Many of them are used for body jewelry, but only a few specific grades are proven biocompatible: steel that is ASTM F138 compliant or ISO 5832-1 compliant."
To be kind, the writing is, to be kind, imprecise.
First, the word "quality" does not apply when comparing metals with different formulas and processing parameters as if 316L could have been better but the manufacturer or fabricator failed to meet intended standards. Alloys are made in an attempt to enhance targeted characteristics by controlling the range of percentages of alloying elements and processing methods. Different yes, but accusing 316L of being a lower quality fails to make this distinction.
Consider the next sentence, "Surgical steel is made of a variety of alloys." is equally off the mark, perhaps even misunderstood. "Alloys are mixtures or solutions of different metals" (BSIMM2004:25) Alloys refer to metals that are composed of a few elements, such as steel, composed of iron and carbon with additional alloying elements, for example, chromium to impart corrosion resistance. As elements are added, properties are changed. Each stainless steel, such as 316L is an alloy, and the number and letter refer to a specific formula range. Perhaps the sentence was designed to obscure the point that a variety of steel alloys are suitable for surgically implanted devices rather than just those that meet F138 standards. It should also be pointed out that the metallurgical literature refers to ASTM standards as "minimum" standards.
The reference to biocompatibility in the quote is puzzling because biocompatibility is not a static quality that is "possessed" by a material.
Introduction to Tissue-Biomaterial Interactions the authors write
Thus, whether a material is biocompatible depends on a suitable host and on material responses in a specific application or, in other words, whether the material performs as intended. (ITBI, 2002:181)
Body jewelry does not possess the many characteristic of "biocompatibility" which is a necessary for implant success: i.e., being bonded with tissue within the body. Body jewelry is not bonded to tissue and is only successful as body jewelry when not bonded or interacting with the body. Stainless steel is a very good choice as a general class of body piercing material because it refreshes its own passive surface. Regular washing and moving the bar is essential to a limited interaction to create a passive surface. Outgrowth and invagination of skin is to be avoided. Body jewelry is not meant to act in a bio-active way the way implants are meant to.
|01-03-2013 Last updated|