Biomaterials information/news

First, this is my personal feelings about this in simple terms......I'm scared! What am I scared of? That some day there might be a shortage of the raw material to make the products my son needs to live, that is his shunt and his cathing needs. That is why I have added this page.  

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BIOMATERIALS: An Introduction

Each year, more than 7.5 million lives in this country are either saved by implantable medical devices — like heart valves and defibrillators — or improved and enhanced by implants such as hip and knee prosthesis.

Most of us assume these devices will always be available whenever they are needed. Implantable medical devices fall into four groups:

1. Permanent implants that save lives, including: pacemakers, central nervous system shunts for hydrocephalus, vascular grafts;
2. Permanent implants that enhance lives, including: replacement eye lenses for cataracts, hip prosthesis, incontinence implants;
3. Temporary implants that save lives, including: emergency airways, catheters, balloon angioplasty devices; 4.Temporary implants that enhance lives, including: bone growth stimulators, wound healing patches, fracture fixation devices.

THE PROBLEM WITH CURRENT LAW

This critically important sector of our nation's health care system is faced with a mounting threat: the dwindling supply of materials used by medical device manufacturers to produce their life-saving products. These raw materials -- called biomaterials -- include silicone, polyester, urethane, and polypropylene.

The primary reason for the biomaterials supply shortage is, quite simply, misdirected lawsuits. Suppliers of raw materials and component parts are being included in litigation regarding products that they did not manufacture or design. Under current U.S. product liability laws, any party involved in the creation of a product -- even remote contributors -- may be included in product liability litigation.

Suppliers are not being sued because their materials were dangerous or faulty, but because they supplied them to a company that made the device. The legal jargon is familiar: it's called "deep pockets" and it is driving biomaterials suppliers out of the medical implant market.

As a result of these lawsuits, suppliers are determining that it does not make economic sense to continue to do business in the medical implant market. The market for raw materials and component parts used in medical devices is minuscule compared to other markets, such as the automotive, electrical, plumbing, aviation, and consumer goods sectors. The profit margin for suppliers who are sued does not justify — or even cover — the cost and risk of a liability lawsuit.

For example:

Whereas implant manufacturers purchased $3,300 of polyacetal resin in 1994, the total sales to other markets was $1.3 billion;

Polyester yarn (PET) sales total approximately $185,000 annually in the medical device market, but are worth $9 billion in the polyester yarn market;

DuPont spent an estimated $8 million per year over a five-year period defending and winning liability cases arising from the use of TEFLONŽ in a temporo mandibular joint (TMJ) implant.

Three major suppliers of materials used in critical medical implants have halted sales to this market:

1. In 1992, Dow Chemical pulled all its medical grade resin and film (materials) from the implant market;
2. In 1993, Dow Corning Corporation stopped supplying silicone for use in permanent medical implants and in all reproductive, contraceptive, obstetric, and cosmetic applications; and,
3. In 1994, DuPont ended a one-year grace period and discontinued supply of materials including TEFLONŽ   (PTFE), DACRONŽ (polyester), and DELRINŽ (polyacetal) to the permanent medical implant industry.

Another eleven biomaterials suppliers have already limited or stopped selling their products for use in implantable medical devices. If this problem is not remedied, the consequences for current implant patients, future patients, American medicine, and American high-tech businesses are dire.

Links of interest

-Case studies-

Nathon Smith -has been hydrocephalic since birth.
Jason M. Dunn -was diagnosed at birth with hydrocephalus.
Magan Birkbeck -shunted at 2 days old
Titus Simonini -has shunted hydrocephalus

Aug 1998 -CLINTON SIGNS BIOMATERIALS LEGISLATION