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Dalkon Shield: Anatomy Of A Con Job

Dalkon Shield: Anatomy Of A Con Job image Dalkon Shield: Anatomy Of A Con Job image
Parent Issue
Day
26
Month
July
Year
1974
OCR Text

"The intrauterine device is really not new. Some estimate that it is over 2000 years old. Camel drivers used to insert stones in the uteri of their female camels in order to prevent conception and birth over long journeys."

How many times have women been told this quaint story about "camel stones"? What did IUD manufacturers think -- that somehow if it was good enough for camels it was good enough for us? The fact is, that those camel drivers didn't know the first thing about how those pebbles work, and we don't either.

 All IUD manufacturers' advertising aside, exactly how the IUD acts to prevent pregnancy is still a matter of speculation. But even more important, we do not know the true pregnancy, expulsion, or medical removal rates for IUDs.

Nor do we know the average number of complications which range from a "minor" complication such as IUD-induced pain to such major complications as surgical intervention, severe infections, and death.

Much of the credit for this state of affairs goes to the Food and Drug Administration (FDA) which regards IUDs as medical "devices" rather than "drugs", and therefore claims that it does not have the authority to require premarket testing of IUDs.

What's more, the FDA cannot require the reporting of adverse reactions associated with this medical device, the registration of IUD manufacturers, or that warning labels be attached to each IUD package.

Once a device is marketed, the FDA can assume a regulatory function if it is capable of proving in court that the product is dangerous to health when used as directed or is improperly labeled. Unfortunately, the FDA only takes action when it is sure it can win in court.

The newest, but surely not the first, victims of this action after-the-fact policy are the users of the Dalkon Shield -- an IUD ecstatically introduced in 1970 as "the IUD that's changing current thinking about contraception."

It certainly is. One month ago, on May 18, the A. H. Robins Co. of Richmond, Virginia, manufacturers of the l Dalkon Shield, sent letters to 120,000 individual physicians. announcing that 36 women had suffered septic (that is, infected) spontaneous abortíon in mid-pregnancy with the Dalkon Shield in place. Of that group, four women died. Scarcely three weeks later, on June 18, A. H.  Robins released reports of two more deaths and 38 non-fatal infections related to the Dalkon Shield. The original "Dear Doctor" letter had precipitated a series of reports from doctors revealing the additional deaths and infections.

According to the New York Times, Planned Parenthood Federation, the largest family planning agency in the US, serving over 850,000 patients, never received that original letter. But they apparently got wind of it, and publicly announced that they had not only ordered their affïliates to immediately stop prescribing the Shield, but also to contact all women who had the Shield inserted, advise them of the health hazards associated with this device, and offer them a substitute form of birth control.

Privately, Planned Parenthood has been phasing out Dalkon Shields for the last two years and only inserting them on the insistence of a woman because, from information gathered at their abortion clinics, the Dalkon Shield pregnancy rate appeared to be higher than had been advertised.

LIARS CAN FIGURE

Though the Dalkon Shield may prove to be no less dangerous than any of the other 40 or so IUDs on the market or presently under experimentation, its history provides a classic example of the misuse of statistics and the general deception employed in the marketing of IUDs.

The first Dalkon Shield ad (appearing in medical journals) based its claims on the effectiveness on a single study conducted by the Shield co-inventor and A. H. Robins Co. medical consultant, Dr. Hugh Davis. The ad claimed a pregnancy rate of 1 .1 percent, an expulsion rate of 2.3 percent, and a remarkable 1 year continuation rate - that is, how many women continue to wear the Shield for 1 year -- of 94 percent.

The ad, however, failed to point out that the study was not conducted on women who had the device in place for 1 year. The 94 percent figure is purely a statistical manipulation. The study was conducted on 640 women for a total of 2,549 "woman-months of use." Dividing woman months by the number of women involved, the average length of insertion time is 5.5 months -- probably too short a time to draw any conclusions and undoubtedly too short a time on which to base an entire promotional campaign.

In November 1972, A. H. Robins updated the medical profession with a 9-page color ad based on 4 Dalkon Shield studies covering 9-12 months, y 3174 insertions and a grand total of "17, 222 woman-months." Dividing again we come up with the pathetic average insertion time of 5.4 months - which A. H. Robms again "neglected" to mention.

Added to this, was a footnote in small print buried near the end of the ad commending that a patient uses another form of contraception along with the shield for the fïrst three months.

As one irate physician who testified before the House Hearings on Medical Devices wrote to the A. H. Robins Co.: "If that 3 month period is subtracted from the 5.4 average insertion study time, one comes to the startling conclusion that you are selling this product with an ad that really makes claims based on a partial guarantee covering only 2.4 months of average time during which the Dalkon Shield is the only form of contraception recommended."

To make matters worse, while these four studies were being quoted in company advertisements, A. H. Robins had in their files at least 10 other independently conducted studies (A. H. Robins says they were "unpublished" studies and therefore not appropriate ad material) showing pregnancy rates as high as 4.3 percent and continuation rates as low as 41%. In what can be considered a calculated effort to mislead the physician and ultimately the female consumer, A. H. Robins chose to base their ad on 4 clearly inadequate but apparently "favorable" studies, while ignoring the other studies which showed unacceptable complication rates.

In response to a complaint by a competing IUD manufacturer that the Dalkon Shield company had made unsubstantiated claims for their product. David Links, Director, Office of Medical Devices, FDA wrote: 'in reviewing the Dalkon Shield advertising, the most that one could say is that there may be a few statements included which rail into the mild puffery category, Otherwise the information provided seems to be reasonable and accurate."

Apparently, the FDA did not take the time to investígate what other information was available to the A. H. Robins Co. at the time of the advertising campaign. Let's just take a moment to look at some oí the mild puffery" found in the Dalkon Shield ads and other promotional material. Clearly, one man's "mild puffery" is another woman's "fraud."

From the Dalkon Shield brochure: 'in the long run, an IUD is less expensive than other available methods."

Perhaps not fraud, but at the very least misleading. Running through a not unusual IUD case - $35 for pelvic and insertion; 100 percent increase in the amount of money spent on tampons and an additional sum for supplemental iron tablets due to excessive menstrual bleeding; a small fee for Darvon or other pain killers following a painful insertion each month to relieve increased cramping during menstruation; a full course of antibiotics, easily a $20 expenditure, as a result of a pelvic infection; $15-$35 for uterine x-rays when the strings disappear but no one is sure whether the IUD has been expelled or is still somewhere in the uterus; and $10 (probably more) to finally have the thing removed.

In an extreme case, $500-$1000 would be needed for surgical removal of a device which has embedded itself in the uterine wall, or abdominal surgery necessary to remove a pregnancy in the Fallopian tube. (Approximately. 1 out of every 25 IUD pregnancies occur outside the uterus)

"Designed for greater comfort...some women have cramps for a short time after insertion, but these are 1 mild and usually pass in a few minutes."

Though there are no reliable statistics on the incidence of pain upon insertion of a Dalkon Shield, doctor after doctor testifying at the House Hearings told of the numbers of women who had fainted from pain following insertion and equally large numbers who, returning to the office to have it removed, have asked to be "put out."

"Designed for better Retention." About the only claim made by the A. H. Robins Co. which is not disputed is the Shield's high retention-low expulsion rate. Without question, the Shield stays in place due to its large diameter and little insect-like legs. Of course, there is no suggestion of what happens when the shield is removed. The ad simply fails to mention that this same design means more insertional, more removal, and probably - more continuing pain.

Clearly, the overall effect of the Shield - and generally all IUD-promotional materials, is that the IUD is a medically safe and dependable method of birth control. As one IUD manufacturer describes it: "Quietly resting in the uterine cavity ('minding its own business as one doctor put it) it provides maximum protection with a minimum of bother."

It is now known (and one might ask how long has it been known and by who) that the Dalkon Shield has not been quietly 'minding its own business" in the uterus. Of the estimated 3-5 million women in the US wearing IUDs, 1/4 to 1/3 of them are wearing Dalkon Shields. Six women have died from Shield-induced abortions and there is no way of v knowing how many IUD-related fatalities have gone unreported. There is no law which says they must be reported. 

So, while the FDA tries to determine whether spontaneous septic abortions are a hazard unique only to the Dalkon Shield; while they consider whether the risks of this device "outweigh its benefits"; while we wait for the results of a nation-wide US Public Health Study of serious  IUD-related complications; and while we watch to see whether the House will accept a bill which would give the FDA authority to require pre-market testing of IUDs (a bill which has been floating around House and Senate 11 committees for several years already), Family Planning organizations and the Dalkon Shield Manufacturer warn us against "widespread panic and unjustified abandonment" of the Dalkon Shield.

This kind of cautious response has been urged upon women before. After having been deceived for so long about other birth control methods (i.e. the pill and its relationship to blood clotting) it is frankly difficult to trust the family planners, the birth control manufacturers, or the consumer protection agencies.

In the past two decades, the FDA has only taken action against one IUD (the Majzlin Spring) and after two years of slow and incompetent investigation, that action was taken only five days before House Hearings on Medical Devices threatened to expose the Majzlin Spring as a dangerous device. Perhaps "'panic" and "widespread abandonment" is exactly what's called for. -- Deborah Larned, LNS