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| Should a flat plate of the abdomen be done if ultrasound fails to locate an IUD that has possibly perforated the uterus? #1214/6 | ||||||
Dear Dr. Hatcher, I am writing this e-mail on behalf of my practice in Bedford, NH. In the past three to four years we have had two incidences of Mirena perforations in women who had their MIrena LNG IUS insertions at six weeks postpartum. In the first patient situation the patient returned at three months for her follow-up appointment. The IUS strings were not visualized and an ultrasound was performed; the Mirena IUS was not seen within the endometrial cavity and was thought to have expelled. The patient could not recall when the IUS could have come out. The insertion process was uneventful and the patient had not called with any problems prior to her three month follow-up appointment. About 1-1/2 years later she presented to the ER complaining of abdominal pain. A series of tests were ordered including a flat plate xray of the abdomen. Incidentally the Mirena IUS was seen in the abdominal cavity. The patient was referred back to our practice and saw one of my backup OB/GYN providers. She underwent laparoscopy to evaluate her pelvic pain and remove the Mirena IUS. According to the physician the Mirena was very easily removed and not adhered to any abdominal tissue. The pictures are quite impressive showing a quite "clean" IUS. In the second situation the patient returned six weeks after her Mirena IUS was inserted and reported that she was unable to feel her IUS strings. The OB/GYN who did the insertion was unable to visualize the strings and ordered an ultrasound. The Mirena IUS was not seen within the endometrial cavity. In light of the above experience a flat plate xray was ordered and the Mirena IUS was seen within the abdominal cavity. According to the provider who did the insertion there were no problems at the time of the insertion. Our questions are as follows: 1) Is it necessary to order a flat plate xray if the Mirena IUS or Paragard T380A IUD are not seen on ultrasound (in situations where there were no known complications during the insertion procedure)?; this is not mentioned in Berlex or Wyeth instructions as the next step in routine follow-up or in the latest copy of Contraceptive Technology. 2) Is it necessary to remove the MIrena from the abdominal cavity since an xray was performed even though in Contraceptive Technology it does say the Mirena does not have to be removed but Paragard T380A IUD does need to be removed? Have we committed ourselves to removing it or can the patient be counseled about not needing to remove it? 3) Have you seen more perforations with the Mirena IUS than Paragard T380A IUDs? 4) Is there more of a risk of perforation with the IUD at six weeks postpartum than say, eight weeks or more postpartum? We would greatly appreciate any information or insight that you or the other authors of Contraceptive Technology may have regarding the above as well as any helpful references. I love Contraceptive Technology and refer to it all of the time; it is a wonderful reference to have. I was very saddened to hear of the death of Felicia Stewart. MD. Happy Holidays! FROM THE 19TH EDITION OF CONTRACEPTIVE TECHNOLOGY: (IN PRESS 2007) To answer your specific questions:
I will send this along to Dr. Miriam Zieman for further comment and when we post it I will provide more extensive references. Reply form D.C., CNM: 12-14: : "Dr. Hatcher, thank you for getting back to me so quickly. Will the recommendations of performing an abdominal flat plate be added to the next edition of Contraceptive Technology or the pocket handbook as part of the evaluation if the IUD isn't seen on ultrasound?" "I will pass this information on to my colleagues and look forward to any other information that comes along from Dr. Zieman. Thanks again!" New comments from D. C., CNM on 3-2-2007: "I am following up on our last email communications regarding Mirena perforations mainly in the postpartum patient. Since my last mailing our office of seven experienced OB/GYH providers, has had a total of five uterine perforations with Mirena IUS (including two patient situations I wrote you about in December). All of these IUDs were inserted after six weeks postpartum up to 2 weeks postpartum. One patient had a history of two Cesarean sections. The patients were sent for X-ray when the strings were not identified on speculum exam or the IUS was not seen within the endometrial cavity on ultrasound. The IUDs were seen outside the uterus on flat-plate X-ray. One patient's IUD had migrated into her omentum. We have heard of another OB/GYN practice that also has had Mirena perforations in women when the Mirena was inserted after the sex-week postpartum checkup." "Obviously, this is very concerning to us. We are developing a QA system and reviewing the chart of all patients who have had Mirena inserted. We are checking to see if they came in for their one-month checkup and/or had any problems, including not identifying their strings by exam or ultrasound. We are also meeting with our Mirena representative next week. We are wondering if there has been an under-reporting regarding Mirena expulsion in the literature. I have not seen this problem with the ParaGard T 380A IUD. We are considering instituting a policy of not inserting Mirena in postpartum women until after three months." "Again, your feedback on this matter would be appreciated." RAH reply on 12-14: I am sure the new information will be added to Managing Contraception but Contraceptive Technology may be too close to printing to get in. Dr. Zieman replied on 12-15: "I agree with everything you wrote. There was a randomized trial of Mirena vs. ParaGard published by Sivin in 1990. Approximately 1124 women got Mirena, 1121 got copper IUDs. There were 5 perforations of Mirena and none of ParaGard, but I don't know what the providers' previous experience was with either devices. In a RCT out of India that included Mirena, copper T380, copper T 200, copper 7 (1905 total), there were only 2 perforations in copper 200 groups." RAH reply 3-4: Good morning, two days later. I share your concern. Five perforations among 7 experienced clinicians is a major problem. Below are several comments from the next edition (19th) of Contraceptive Technology (chapter by Dr. David Grimes) He notes that the most important factor is the skill of the individual(s) doing the insertions. A group should have inserted 5,000 or more IUDs to have had 5 perforations. I remember a gynecologist who had perforated the uterus of 5 or 6 women using Lippes Loops several decades. He was fairly rough in a number of ways. It led me to include this phrase in discussing IUD insertion and removal: "Every step in IUD insertion and removal should be done slowly and gently". Perforation Perforation of the uterus can occur at the time of IUD insertion; no evidence supports that notion that IUDs "migrate" outside the uterus thereafter. The most important determinant of the risk of perforation is the skill of the person doing the insertion "the magic is in the magician and not in the wand" In experienced hands; this risk is 1 per 1,000 insertions or less.
I will send this to Drs. Zieman, Creinin and Grimes for their comments. Please see Dr. Zieman's comments, five perforations in one practice suggests that mistakes are being made. From Dr. Mimi Zieman 3-4: I agree with Dr. Hatcher that this is concerning and that the group needs to review the proper insertion technique for Mirena (as it differs from ParaGard). There were several perforations in the Regarding under-reporting ? there is always the risk that there will be more adverse events in post-marketing use than in clinical trial use. Despite not having uniform post-marketing surveillance systems in place here in the
Mimi Zieman, MD Associate Professor of Gynecology and Obstetrics Key Words: Mirena IUD, ParaGard IUD, perforations, insertions, postpartum, strings, ultrasound, endometrial cavity, expelled, abdominal pain, flat plate X-ray, laparoscopy, pelvic pain, Berlex, Wyeth, Contraceptive Technology, counseling, uterus, adhesion, adnexa, omentum, bowel, progestin-hearing devices, copper-bearing, Speroff and Darney's A Clinical Guide to Contraception, Guillebaud, Dr. Mimi Zieman |
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