Subject: FDA Reviews Latex in Medical Devices After Influx of Fatal Allergic Reactions 
Date: Published: 2/25/92 (95 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Health:
    FDA Reviews Latex in Medical Devices
    After Influx of Fatal Allergic Reactions
    ----
    By Bruce Ingersoll
    Staff Reporter of The Wall Street Journal

    WASHINGTON -- The Food and Drug Administration, alarmed
 about a raft of fatal allergic reactions to latex, is turning
 its focus to the use of the natural rubber in hundreds of
 medical devices.
    Senior FDA officials say the agency is taking a "new look"
 at latex as part of its review of medical devices marketed
 before and after 1976, the year the agency was empowered to
 regulate the medical device and technology industry.
    The special review of latex has been prompted by an influx
 of adverse reaction reports, including more than 50
 fatalities among highly allergic patients and medical
 professionals who went into anaphylactic shock, according to
 FDA and industry officials.
    "We didn't become aware of this until a little over a year
 ago," says Alan Magazine, president of the Health Industry
 Manufacturers Association, which represents 300 major
 medical-device manufacturers in the fast-growing $34 billion
 industry.  "There have been reports of 50 or 51 deaths."
    In the past, the FDA has sent out warning letters to
 physicians and other medical professionals about latex
 reactions.  The current regulatory review is likely to lead to
 a large-scale relabeling of latex products -- including latex
 gloves, condoms, catheters, dental dams and enema kits -- to
 highlight the risks of latex hypersensitivity.
    "Latex is in hundreds of medical products, which means it
 could have profound impact on patients and health-care
 workers," said Mr. Magazine.
    Complicating the health implications is the rising use of
 latex gloves in the era of AIDS, or acquired immune
 deficiency syndrome.  "Gloves are now being worn more and more
 by medical workers for protection against sexually
 transmitted diseases," Mr. Magazine added.  "It's possible to
 become allergic to latex from continued use."
    At the same time, Mr. Magazine cautions against
 overreaction to the adverse reactions reports, as do FDA
 officials.  "You still have to look at the risks and
 benefits," he said.  "It's not a situation where people should
 panic.  The incidence of problems with latex is infinitesimal
 as compared to the number of procedures involving latex
 products on patients."
    While investigating the latex problem, the agency will
 continue the slow process of calling for safety data on 31
 so-called high-priority devices that already were on the
 market in 1976 when the medical device law was enacted.
    Manufacturers of the high-priority devices will be
 required to submit scientific and medical studies for the FDA
 to evaluate, just as Dow Corning Corp. and other
 manufacturers of silicone breast implants were required to do
 last year.
    The devices include dental implants, cardiovascular
 devices, testicular prostheses, shoulder and knee-joint
 implants and lithotripters for breaking up gall stones,
 according to FDA officials.  As reported, saline breast
 implants will be among the first to be evaluated.
    The review is expected to take several years, officials
 say.  The agency recently finished reviewing the safety of 11
 types of pre-1976 products, including heart valves and
 intrauterine devices.
    At the same time, the agency intends to re-evaluate the
 safety of several devices that previously passed FDA muster
 despite somewhat weak "safety foundations," as one senior FDA
 official puts it.  Manufacturers will be asked to subject some
 of these devices to new tests for tensile strength and cyclic
 stress, he says.
    Meanwhile, an industry task force will meet here tomorrow
 with representatives of the American College of Allergy and
 Immunology to further explore the extent of latex
 hypersensitivity.  "At this point, it's fact-finding," says
 Mr. Magazine.  "I don't pretend to know what the answer is."
    Some of the early reported cases of latex hypersensitivity
 involved young patients with spina bifida in Minnesota,
 according to FDA officials.
    Latex is natural polyisoprene, produced by the rubber
 plant and milkweed.  FDA officials believe proteins in the
 latex are to blame for the allergic reactions.  Many of the
 cases involve latex coming in contact with mucous membranes,
 including the respiratory tract.
    Officials believe the problem might be reduced by
 latex-processing changes -- conceivably, repeated washings --
 that would lower the protein level in products.

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