respect which only a recognition of their complication producing potential can produce. Then, about a year ago, I faced a crisis. In my practice there were at one time 6 women pregnant while also using the Dalkon Shield IUD). All 6 of those women either had or were to go on to suffer serious complications with their pregnancies. It was then that I looked with renewed candor at the glossy advertising for that particular IUD. What I found at first intrigued and then revolted me. I extended my search through the advertising for the other IUDs. I reviewed the medical literature and pulled articles from popular women's magazines. I wrote and phoned drug companies, the FDA, the FTC. I talked to other gynecologists. What I found was the proof that despite adequate proof that IUDS are capable of producing serious and even fatal complications in young women, they are in that lucrative arena of medical devices which breeds poor research, - being beyond FDA regulation - deceptive advertising, and actual medical hucksterism. I still use IUDs for the selected patient whose needs contraindicate better or safer contraception. But that patient receives from me a thorough discussion of IUD contraception so that her choice is based on informed consent. I will now give an over-view of IUD complications from a clinical viewpoint. I then will present a quick panorama of the jungle of IUD invention and promotion. Finally, I will present what I feel are long overdue proposals for the regulation of IUD testing, manufacture, and promotion. IUDs allow unwanted pregnancies. And from a clinical standpoint these pregnancies are much more frequent and disastrous than the false advertising and misleading statistics of IUD promoters and manufacturers would indicate. But what is more important to the physician and his patients is the disastrous nature of IUD incurred pregnancies. These dire complications of IUD pregnancies are absolutely omitted from any mention in either advertising for the medical profession or patient @ 17 information pamphlets. What are these dire complications which IUD inventors and manufactures so studiously ignore? First, IUD pregnancies are inherently unwanted pregnancies. This is basically true for a pregnancy which comes along while a woman is using any contraceptive. But most IUD users are persons who have made a long term commitment to avoid pregnancy and for whom pregnancy would be a disaster. They have been led to believe that they are basically 100 per cent safe. But worse than this are the hazards to health and even the life of the woman who becomes pregnant while using an IUD. Although no exact figures for such matters are ever available, several investigators have found that between 40 and 60 per cent of pregnancies which occur with IUDs in place terminate in abortions. This certainly corresponds with my experience. I have not documented it, but I also feel that those newer devices which have been designed to make contact with a larger portion of the uterine Jining cause a higher number of miscarriages. Now it would seem that a miscarriage abortion - would be desired in the cases where a woman became pregnant while using IUDs. And certainly, any large abortion clinic will confirm that many of their clients come seeking a therapeutic abortion and the removal of the offending IUD. The problem with IUD pregnancy-miscarriages is that they are not simple statistics in someone's textbook or paper, but that a major proportion of these miscarriages are serious medical emergencies requiring surgical completion with or without anesthesia, frequently the transfusion of whole blood, and often the use of massive doses of antibiotics because of infection within the incomplete miscarriage. Another well documented complication of IUD-related pregnancies is that they are frequently located outside the uterus. This is usually within the follopian (uterine) tube, but may be elsewhere within the abdomen. About one in 25 IUD-related pregnancies are extrauterine. The clinical significance of this is that it is often hard to diagnose, always requires major surgery, usually requires blood transfusion, and must be considered a threat to the life and future fertility of the woman. It must be emphasized that an IUD pregnancy is not only unplanned and unwanted, but often leads to a complicated miscarriage or ectopic pregnancy which seriously effects the health of the involved woman, usually requires surgical or medical intervention, and is very expensive. 1UD COMPLICATIONS: Insertional Pain The A. II. Robins Company in its information brochure for Dalkon Shield users __condescendingly allows that "some women have cramps for a short time after insertion, but these are generally mild and usually pass in a few minutes." The person who wrote that was probably a man and most certainly had never undergone the experience of receiving a Dalkon Shield. A recognized complication of IUD insertion is pain. Certainly some patients are able to tolerate pain more than others. And it is also true that a woman whose cervix has been previously dilated. by a pregnancy will generally undergo less IUD insertion pain than the woman who has never been pregnant. But the general dismissal of this side effect in company brochures like the one put out for the Dalkon Shield is definitely misleading and borders on falschood. 3 I have seen a number of women faint following IUD insertion and particularly from Dalkon Shield insertion. This probably relates to the large diameter of the Shield which, with its applicator, must be forced through the cervix. I also find it interesting that many patients - expecially those having undergone severe pain during insertion look forward to - its removal with such apprehension as to request to be "put to sleep" during that fateful event. This, of course, is rarely done, but many patients benefit by being given pain medication prior to the removal of the IUD. In fact, pain medication, a lead bullet to bite on, and a short memory are the requisites of some IUD removals, particularly with the Dalkon Shield and the Majzlin Spring. 22-265 - 74-26 IUD COMPLICATIONS: EXCESS RADIATION EXPOSURE I know that many persons especially IUD inventors, manufacturers, and promoters The complication I am alluding to is the excessive mumber of x-rays which must be taken of women's abdomens to localize misplaced or lost IUDs. Whenever the IUD string cannot be seen or located at or within the uterine cervix, and when a woman presenting with such complaint cannot document that she expelled her IUD, then an x-ray is usually taken of her entire pelvis. It can be granted that the IUD is often in its normal place even though the string cannot be seen. But an x-ray must be taken to verify that. This situation can occur through a number of interesting and common ways. I have seen several Lippes Loops which have worked themselves into an upside-down position in the uterus pulling the string up out of sight. Even the string can migrate out of vision from the vagina into the true that some upper cervix or uterine cavity. It is an unfortunate commentary |