Intrauterine Contraception: A First-tier Choice Throughout the Female Reproductive Life Cycle

Transcription

1 Transcript Details This is a transcript of a continuing medical education (CME) activity accessible on the ReachMD network. Additional media formats for the activity and full activity details (including sponsor and supporter, disclosures, and instructions for claiming credit) are available by visiting: Released: 12/18/2015 Valid until: 12/18/2016 Time needed to complete: 45 minutes ReachMD info@reachmd.com (866) Intrauterine Contraception: A First-tier Choice Throughout the Female Reproductive Life Cycle Narrator: Welcome to the Omnia presentation of Intrauterine Contraception: A First Tier Choice Throughout the Female Reproductive Life Cycle. Please take a moment to review the faculty information. Please take a moment to review the learning objectives. Presenter: Good morning, everybody. Are we having fun? Several: Yes. Presenter: All right. Thank you, Lee, for warming them up for me. Okay. Today, and pointed out in this article, what is emerging from this country is tremendous disparities in access or utilization of the very most effective methods of birth control, and what we are seeing is increasing levels of problems 2018 ReachMD Page 1 of 15

2 concentrated among the poor and among the young, and also the minority groups, that what we are seeing is that the more wealthy, Caucasian, in particular, women are being able to access IUDs and implants and their unintended pregnancy rates are going down. So, clearly, we need to focus on making these available across all areas. If we look to see women at risk and what they are doing in terms of contraceptive use, we can see that 50% of women say that they are consistently and correctly using their method of birth control. We'll talk about that. No use, and that is ongoing no use, it's not episodic, right? Because we have a lot of women who are having these little gaps, right? I ran out of pills, ran out of condoms, all of the issues that we have about almost making women come in to get 1 pill at a time or maybe 1 pack at a time and then we're going tisk, tisk, tisk, you know, you're such a bad pill taker. So, gaps that are there and then inconsistent use, so we have quite a... we have only 50% of people who have chosen a method and are using it consistently and correctly. It doesn't mean that they are using the most effective, but they are doing the best they can. So, the question is: Why do unintended pregnancies happen? Certainly, the nonuse of contraception when a woman is sexually active and pregnancy is not* 2:08, and there are all these wonderful studies that have looked at women who do not use contraception. And you ask them, Why was it you didn't use contraception at the time that you got pregnant when you didn't want to? And what's the number one answer? I didn't think I could get pregnant. How many times have you heard that? Yes? And it's not just the teenager who has all of 3 months of experience on which to base her thing. It is the perimenopausal woman, right? It is women who really ought to have known better or maybe just never got taught about the issue. Clearly, we have method failure or inconsistent use, and then the switching of methods are gaps that are there. You know this already, that the most effective reversible methods of birth control are implants and IUDs and that we have the various types of IUDs and that they are all so very good, the differences between them. And what we should be counseling women on, I believe, is the typical use failure rate. Now, that never comes from a clinical trial because those are not typical subjects. Are they? We exclude women who have problems, right? We exclude women we don't think are going to be able to follow through on the study. Right? And then women, and we gave them all the supplies and we scrutinize them to make sure that they use it the way they are supposed to. So, when we are talking to people about what to expect from the method, let's talk typical use. Let's tell people who are starting the pill, On average 9% of women get pregnant the first year that they're using the pill. Right? And another good number that has come out of the Choice study is that women who choose pills, patches, rings or shots have 20 times the pregnancy rates as women who choose the implant or the IUD. Now, usually, we don't like to quote relative risk, but I think that is one that really grips us and we want to pay attention to 2018 ReachMD Page 2 of 15

3 it. We want to talk about permanent contraception, and you'll notice that is the new terminology. We do not sterilize women. We are not beakers in some sort of experiment, right, that we flash sterilize? Permanent contraception, and that puts it in terms of contrast to reversible methods. And we do know that post sterilization regret is quite common, and it is much higher in younger women and in single women; so we want to make sure that the woman at this moment is as convinced as she can that she absolutely doesn't want any children and that she can use something that protects her fertility and her options even though at this moment she may not want to use it. So, let's talk about the long-acting reversible contraceptives, which we will in this talk because we are talking to each other, use this terminology; but please, I'm going to come at the end with some breaking news. Do not use this term when you are talking to patients. Okay? We'll come back to that a bit. So, we have the progestin-only subdermal implant. We have copper IUD. And you'll notice the pleural on the progestin-only IUSs. Now, way back in 2011, ACOG put out this recommendation that IUDs and implants really ought to be first-tier methods for women of all ages and all parity, and they took a really good look at the data and have been encouraging us all to use it, so it should be first-line contraceptive, that these methods have very few contraindications. Here comes another bulletin reminding us, building on the data that has subsequently come from many other studies, just reinforcing the enthusiasm that they had in their first bulletin. This is a Committee opinion again and saying we need to increase access. And here, because they can't change insurance companies, they are telling us to advocate for better access and for us in our practices to remember that these are first-line methods and to find ways to integrate it into our practice. And to the point of integrating it, that she comes in today and wants to start an implant or an IUD, we place it today. Okay? So, finding ways in our own practice to streamline that, that is the hallmark of the CDC's Quick Start and certainly that is quick starting the very best method. And when we stop and think about it, why would we ever offer a woman a less effective method and make her fail that method before we give her the best? Right? That just doesn't make sense, and so having us reverse the order in which we are offering things; and counseling women, we should counsel women about the most effective methods before we mention any of the others in the lower areas. So, the other piece that was very exciting was last time, last year at this time, the American Academy of Pediatrics came out and said exactly the same thing. Wasn't that wonderful, to have them say that implants and IUDs are first-tier methods for adolescents? Of course, they have to say for adolescents who choose not to use abstinence, but okay, that's fine, we certainly want to encourage abstinence and make sure that our young people are protecting themselves both from pregnancies and from STDs ReachMD Page 3 of 15

4 So, the ones that are commonly used today listed in efficacy are listed there. So, this is the statement. Certainly, 80% of adolescent pregnancies are unintended. Right? And so that we want to make sure that they use the most effective methods. Now, why do we have this? Now again, if you thought LARC was a silly name, how about SARC? Right? Short-acting reversible contraceptive, these people You know, never mind. Anyway, this was the study that you know about that completely spun us around and really gave us solid data on the acceptability of top-tier methods, continuation rates and the efficacy. And so this was that very special study that was funded by an anonymous donor in St. Louis where they do not have really good access for women to these methods, and they said you can come on in, join the study for 3 years, and we will give you any of the first- or second-tier methods and you just, if you sign up for it, we are going to put you through some counseling and then you can have any of those methods. And you have the freedom. If you don't like your first choice and you want to switch, you just have to choose from that same menu. And so they have given us more than a dozen studies that really have been eye-openers and shakers and movers. And you can see there that regardless of age, we saw the women, based on the counseling they were given, lined up in droves to choose IUDs and implants. Now, many people have said, Well, that s because you gave it to them for free, but all of us here in this room who work with FamilyPACT know that when women are given anything for free, they may not choose. In fact, our utilization in the FamilyPACT program of IUDs is about 13%. They had 75%, 76% of women choose IUDs or implants, so clearly something about the counseling changed their minds, and ordering it in the order of efficacy I think was one of the things that really did it. So, the characteristics of these methods are that they're top tier, they're rapidly reversible, which we say in some people may be a benefit and others not. For the bean counters they are extremely costeffective, and they are working to block fertilization, so that is contraceptive not abortification, not interceptives. So, who can use it? Anybody who wants highly effective contraception. Can you imagine a woman, "No, I don't really care whether it works or not, you know? Just as a point here, when we go and we are so enthusiastic about these methods where in everyday typical use they are exactly as effective as they are when people use them correctly, yes, when we have something that delivers contraceptive protection at a level of reversible methods that are as equal to permanent contraception, we are all electrified by this. Yes? This is new that we are just feeling empowered, we're so excited about it, and we get a duh from the patients. And do you know why? Surveys show us that women think that every method works well. I'll tell you, I just did a survey of condom users, and over half of them rated the efficacy of the male condom to be 99%. Is that amazing? So, we are out there, Yeah, this will 2018 ReachMD Page 4 of 15

5 really work, this will protect you, and she's going, Hmm, okay? Very interesting, isn't it? So, I think that they are interested in side effects, they're interested in other things, and we need to kind of change their frame of reference or just blow it off and let's talk about the ease and the convenience and the side effects. Right? Just pitch it in the terms this they want. So again, women who desire no future pregnancies or women who desire future pregnancies, I think that that's wonderful. She's parous or nulliparous, it doesn't matter. The beauty of the intrauterine contraceptives and the implants is that efficacy doesn't require any patient action. Even if she doesn't check her tail strings every month it's going to work for her. High rates of satisfaction, we saw that again in the Choice study; no estrogen, and so it certainly can be used by women who couldn't use birth control pills; significant reduction in average monthly blood loss in the LNG IUS, particularly the Mirena; reductions in the volume and the size of myomas; but that again we are not using it in women who have really big fibroids, not the Harbor fibroids -- we are talking about ones that are less than 4 cm -- and certainly can be used in the management off label of endometrial hyperplasia. And certainly, both IUDs have been known to, and the implant, to reduce the risk of endometrial cancer. And we are so concerned about that now because the rates of endometrial cancer are just skyrocketing, and we all know that it is in parallel with the obesity problem that we have. We know that compared to permanent contraception, IUDs provide reversible options with efficacy that is comparable, and as we said, the regret is not a problem. If you want to have another child, you just get it removed and stand back. The reversibility is very rapid. Contraindications to IUD use, we just think -- and this one is important -- when I am and when you are talking to a woman about a birth control pill, if she inadvertently takes the birth control pill after she has conceived, is that going to have any adverse impacts on the pregnancy? Absolutely not, right? Of course, she's nibbling her, you know, she's very worried about it, but we know from 60 years of experience, even though pregnancy is listed or suspected pregnancy is listed as the number one contraindication on every method, the issue around those methods is there is no benefit to her. So, if there are any risks, there is no offsetting benefit, and that is why it's a contraindication. But when we are talking about IUDs, if we place an IUD in a pregnant woman, could we harm that pregnancy? Absolutely. So, this one we pay attention to because there will be definite harm to the pregnancy and maybe even the woman if she should start bleeding and contract, so we definitely want to make sure that a woman isn t pregnant. Now, does that mean we have to do a pregnancy test for every patient we are placing an IUD in? No. Right? We have those little 7 questions. If she is on her period, if she has been using an effective method, if it's moving one IUD out and putting a new one in, all of those types of things. We don't want to tie it to a laboratory test, but just be thinking carefully that we want to screen women either by history or laboratory before we place the IUD. And this is particularly true 2018 ReachMD Page 5 of 15

6 today since we are recommending the placement of the IUD any time in the cycle when we know she is not pregnant because we want to streamline her access to it. If she is infected, if she has any unexplained vaginal bleeding, we want to know why it is that she has it. She could be pregnant. If she has endometrial or cervical cancer, she is probably going to be sterilized by the therapy, and we don't want to be entering that uterine cavity in those conditions. If she has breast cancer or has had it in the last 5 years, progestin-only IUDs are not used. I remember the days when the copper IUD was contraindicated for women with cancer. Do you remember that? Women on chemotherapy, right, we weren't supposed to give them an IUD because if they should get an infection, they wouldn't be able to manage it as well; it would be much more complicated. And today we are sitting here saying, you know, that's a great use of the copper IUD is when a woman is under chemotherapy for cancer. And you can look through the rest there. Certainly, Wilson's disease, how do we screen for Wilson's disease? Look deep in her eye and look for that little ring? No. Ceruloplasmin, we're not going to bankrupt the system that way. I'm a gynecologist. I say, Do you have which Wilson s disease? And if she says, What s that? odds are, unless she s watched House... Do you remember that episode? (Laughter) I gotta tell you that's the only one I got in the first 60 seconds. Sick lady with a copper IUD, must be Wilson's disease. He wasn't as fast as I was. (Laughter) Okay. So, what are the ones that we have? We have the copper IUD, and right now in this country we have the best one in the world so far, and that is the Copper T 380A. We have 2 of the larger levonorgestrel IUSs with 52 mg of levonorgestrel in the stem. And the brand names there, number one you know is Mirena, and what is new today is the Liletta, which is very similar to the Mirena, as you will see, and we have what we call baby bear, Skyla, with 13.5 mg of levonorgestrel in the reservoir. And, of course, we have the implant, the single implant also. So, we are looking at mechanism of action for the copper IUD. This works... I love the way Dan Michel*17:18 characterizes it. It is a functional spermicide. It keeps the sperm from moving forward. And if you get a couple of them that just limp up there to the egg, the acrosomal enzyme activation is impaired so they can't drill through the zona pellucida and have a union of the gametes. How do the levonorgestrel IUSs work? They are a wall of China at the level of the cervix. We have beautiful pictures from USC where they take snip little pieces of the cervical mucous at the time of ovulation, smear it out over a slide and flood it with sperm, and those little guys can't get more than a 2018 ReachMD Page 6 of 15

7 millimeter. And you know they have to swim up there 2½ cm to be able to get to home plate. They have different standards. (Laughter) Okay. So, we definitely have those, and the differences right now on label, copper IUD is approved for 10 years. You know Planned Parenthood off label routinely recommends 12 years. There is some data, maybe 20, right? The LNG IUS, the Mirena that has been out there for, well, around the world a quarter of a century is approved for 5 years. Right now Liletta has 3-year approval. Do you all remember when we got ParaGard the first time in 1988? How many years was it approved for? Four years. And then it grew to? Four years later they came back and said, Oh, no, no, no, no, no, we can go to 6. But you told me 4. Okay? And then we went to 10. So, we anticipate that this may have a good potential for growing. The fourth-year data are already before the FDA. The study is progressing. And the investigators, I will tell you, have filed an intention. They are going to continue this study and see if they can get 7 years of protection out of this one. So, hold tight. Right now we're telling the patient 3, but it's a stay tuned, right? We are laying the groundwork for maybe it will extend beyond that. But, on the other hand, the Skyla, the 13.5 mg one, we're saying 3 years. Huh-uh, no more, because we have squeezed that little sucker dry. We are starting at a very low dose because we don't want to have systemic absorption that may cause breast tenderness. We don't want to have high levels in the endometrium that will induce high levels of amenorrhea. So, you can see how you can kind of choose among the different ones that we have today. So, we have talked about the mechanism of action, and this was really the study that showed us when you took the ova out of women at midcycle after coitus, the women who had IUDs in place showed absolutely no evidence of fertilization. There was no splitting of the cells from 1 to 2 or 2 to 4, so it was working as a contraceptive. What caught our attention as repro folks was, though, in the control population who similarly had single episode, midcycle, unprotected intercourse, half of the women demonstrated fertilization. And you know we only get about a 20% pregnancy rate, so that demonstrates high levels of wastage before implantation. So, similar to sterilization -- and I love this -- now that Lee is here and we are talking about preventing ovarian cancer, perhaps, this idea of doing salpingectomy in women to reduce the risk of later serous I think may be important to us too, so we may be revisiting; but certainly, in the general, salpingectomy for all the techniques that we are doing, partial salpingectomies, the copper IUD and the levonorgestrel IUS are equivalent. So, first-year failure rates, we already showed you this, and I think the importance of this slide is to remember if we don't give them anything or if they don't use anything, 85% will get pregnant, and 2018 ReachMD Page 7 of 15

8 people forget that. If you ask a group of people -- I talk to my students up at UCLA -- and what do you think, 100 couples having unprotected intercourse for a year, and I get estimates, Oh, 20%. Well, that's the first month. Let's keep going. Okay? And I think that people underestimate the fertility of our species. All right, so we have certainly fantastic contraceptive efficacy. The advantage of the copper IUD is that you can certainly use it in a lot of women who may not want to have hormones or may not be candidates for hormones, so a lot of women with medical comorbidities, this may be a very important choice. It has been demonstrated to be the most effective emergency contraceptive, but here I think we have to be honest. When you are mucking around inside the uterus placing an IUD with a sound, with a tubing and all of that, you may be just upsetting the endometrium and you may block implantation; so in this context, the copper IUD may be functioning as an interceptive. It might even disrupt an established pregnancy if we were in there, as we discussed earlier. So, in the context of ongoing contraception, we do know that it blocks fertilization, but the placement of it itself may have a different mechanism of action. We really want to make sure our patients are comfortable with that. But the failure rate as an emergency contraception is 1 in 1,000, so it's really very effective, and it reduces the risk of endometrial cancers. Contraindications to the copper IUD would be the same that we are talking about. We don't put it in pregnant, infected or cancerous women. If she can't, has a really a distortion of the uterine cavity and we can't get it up to the fundus, if she has Wilson s or an allergy to copper, I don't think we want to use it. We know the noncontraceptive uses include protection against endometrial cancer and as emergency contraception. You say to yourself, I understand levonorgestrel. It's a progestin, right? And in women particularly who have anovulatory cycling, we are not allowing unopposed Estrogen stimulation, so I can understand that. How in the world can a copper IUD provide that protection though? And some people have suggested the inflammatory changes that they induce in the endometrium may be protective. I don't know. I think that the former claim that it also reduced the risk of cervical cancer has been answered by selection bias. We don't put IUDs in women who are at high risk for STDs including HPV, so I think that we can understand that one a little bit better, but this is kind of curious. Disadvantages, they have a heavier scheduled bleeding and an increase in cramping. One of the things we have learned in the past though is that we can bring her back to baseline losses with the use of NSAIDs routinely, so I think that shouldn't be a showstopper unless she already has excessive bleeding. And the placement of any IUD can result in perforation or expulsion. Interestingly, the newest data show us, guess who is at a higher risk for expulsion of an IUD, a nulliparous women or a 2018 ReachMD Page 8 of 15

9 parous woman? For years we said it was nulliparous. Do you remember those? Sixty percent increased risk. Turns out we were wrong. It turns out that the smaller the uterus the lower the risk of expulsion. Isn't that cool? Yeah, so that goes back to our first thing, if we can get it into that little nulliparous uterus, then the risk of expulsion is reduced. And should she become pregnant, the risk of ectopic is increased. And if she leaves it in place, premature delivery is also at a higher rate. Now we have, as we said, the 2 different doses, 3 different IUDs, and we know that the larger dose IUD is slightly larger. It's 32 mm by 32 mm. And they have renamed them by their first-year release rate, so they are calling Mirena the 20, they are calling Skyla the 8, and there will be a new one coming out. There is a mama bear in between that is before the FDA and it is going to be called a 12. So, right now we have these and we have already described them. Efficacy of the LNG IUS has been studied in many, many, many, many different studies, but here you have one combined one; 12-month pregnancy rate was less than two-tenths of a percent, and the cumulative pregnancy rate was still less than 1%, and it was rapidly reversible. We have to tell women to protect themselves the next day, don't we, or maybe even that night? The LNG IUS with 13.5 mg, again tested, and these were tested in women 18 to 35 for efficacy, and we had women who were older than that for safety. And this was the first large study that involved nulliparous women, and almost 40% of the women were nulliparous. Another 10 had only delivered by Cesarean section, so that gave us good data about the ability to place it in that setting and whether or not we are going to perforate the scar or not, and very rapidly reversible there too. Now, what's new is the Liletta. And I don't know if you know or not, but Bayer Pharmaceutical or Healthcare, pardon me, Bayer Healthcare never patented Mirena. What they patented was the introducer. Does that make sense? And over the years they maintained as they have evolved the thing from a plunger to a one-handed to the ebiform where you have got not even any strings, you don't even have to pull it in yourself, you just advance it, all of those were patented. So, it was perfectly feasible for a foundation to step forward, a foundation that wanted to reduce the risk, the cost of contraception, to step forward and utilize a carbon copy of the Mirena. Now, it isn't considered a generic because the FDA says, No, no, no, no, you've got to do a clinical trial. You can't prove to me at the end of 3 years or 5 years that the systemic levels are the same because that's not how it works. We need clinical trials. So, they have this very robust study, and they have demonstrated efficacy. You can see how very low the pregnancy rates have been throughout these 3 years and that at 3 years we are still less than 1% and the rapid reversibility. Now, what they don't tell you, look at the age of the women there. Where did they start? Sixteen, okay? And this is an even larger study. It involves more than half of the women are nulliparous. So, we have adolescent women, we have nulliparous women in large numbers. And again, the safety has been studied in those groups, and there are just lots and 2018 ReachMD Page 9 of 15

10 lots of data coming out. So, I think that... And remember, this is the larger one. This is the 32 by 32 mm IUD. All right. And it has its own little unique introducer that you do want to have practice with before you try placing because it has a couple of little things you need to know about. So, IUDs should not be used by women who are pregnant, and the contraindications I think you know, it's all the same sort of things, pregnancy, infection, and you can look at that all together. If a woman is diagnosed with an STD or a PID while she is on it, the latest CDC recommendations that came out last June hold tight; in fact, they even strengthen it. They say clearly not may be left in place but can be left, should only be removed if she doesn't respond to the antibiotic therapy. So, I think we are realizing that it isn't like a sliver in the skin where she is never going to get better until you take the sliver out. The IUD didn't bring in the STD. They are not hermetically sealed with chlamydia or gonorrhea on them. She has to go find her own. And you can treat around it. Most common adverse reactions, as we talked about with the Mirena during the clinical trials, were the abnormalities and the bleeding, and I think we have all gotten very good at counseling women. But it is strange, isn't it, sometimes, when you get the women through those first couple of months of unscheduled spotting and bleeding and they finally hit amenorrhea and they should be doing a little amenorrhea dance, yes? No bleeding, yay, yay, yay. You get the panic reaction from some of the ladies? Right? What happened to my period? Where did it go? It's still up there. It's going to come down, right? And they don't tolerate it because in their minds it means that they are infertile or whatever else there is there. I think we want to screen women for comfort with amenorrhea before we select among the different IUDs. I think that that would really help us a lot. And we can see the bleeding. Now, the ovarian cyst numbers are high, much higher than we would expect because these were not symptomatic women. Remember, we did ultrasound studies on these women, and anything greater than 3 cm and had a cystic structure was reported as a cyst, and Andy Countiss* 30:41 and his group in every one of these has gone through and shown that they do resolve, but they resolve more slowly because under the influence of progestins, there is slowed apoptosis. When you are looking at the LNG IUS with 13.5 mg, same sort of pattern but, again, bleeding is a big one. Now, vulvovaginitis, okay nausea, I love that one. My favorite was pharyngitis, not him but her. (Laughter) And those are some of the things that you have as a problem whenever you are doing a long study. Never do research in winter because everybody gets the flu and you get nausea, vomiting. Yes? 2018 ReachMD Page 10 of 15

11 Totally, you get all these nonspecific complaints that are there, rashes in the summer when they trip over the... Okay. Noncontraceptive uses of the LNG IUS, menstrual blood loss is decreased, but as I said, in the clinical trials we only went up to 4 cm size myoma, and we had to make sure that it didn't distort the cavity itself. Heavy menstrual bleeding, we know that this is the most effective medical treatment. There is a close second with 1 pill with levonorgestrel and estradiol, which has gone nowhere in the United States but is available, and interestingly enough, the LNG IUS with 52, so the Mirena but not the Liletta. The Liletta is not approved in the United States for heavy menstrual bleeding. They did not get that indication, so you will be prescribing it off label but remembering that it still has the same amount of hormone in it. You may feel very comfortable in doing that. Adenomyosis does not respond very well to endometrial ablation, but it certainly does to the LNG IUS. In fact, some people are actually ablating and then popping in a Mirena, and I m saying, How about you just try the Mirena first? Right? Let's forget the ablation. Let's prove that she really does need it. Endometriosis, yes, particularly around the uterus itself very helpful. In some parts of the world, they are placing in the Mirena, and if that is not enough, they add the implant to suppress ovulation. Isn't that a very expensive but cool sort of approach? Disadvantages, the potential amenorrhea, as we said, may be distressing to some women. We do get spontaneous expulsion most commonly in the first year. Uterine perforation, in general, had been 1 in 1,000, but as you know, we have seen 6-fold increased risk in perforation in women who are breast feeding and within 36 weeks. That is still less than 1%, yes? And we all know how to be very careful as we are placing it in those women to make sure that we don't get perforations. And then if the pregnancy is diagnosed while it is in place, we do definitely want to make sure that it is intrauterine; and if the strings are in the vagina, then we want to remove it. Are there differences in efficacy? And this was an interesting study that we just presented and reviewed this last week again at FIGO, and it was looking at copper IUDs. And this was 6 countries in Europe, and they use a lot of the 200 square millimeter IUDs, copper IUDs. So, it may not be as germane to us, but it was interesting to see that both of them worked very well and that the mixture of copper IUDs didn't work quite as well in protecting pregnancy, against pregnancy; but they did have a lower perforation rate, and I think part of that is that the arms are tucked down. Are you with me on this? And so we advance it to the fundus and then we let the arms spring, and I think early on that maybe when we were learning for the arms that go up and you release the arms, when you got that little training kit, those little arms pop into a T faster than anything. Right? They just snap open to you, right? But inside the uterus, the uterine walls can compress that, and maybe there is a big old blood clot and they have to struggle to open up, right? And that is why they say wait 10 to 15 seconds, 2018 ReachMD Page 11 of 15

12 because if you don't have them opened up all the way and you advance it as a Y, can you see how you could shove one of the arms into the wall and then over time it can work its way out? So, I think when we are dealing with IUDs arms up, that we really do want to remind our colleagues and everybody else, take that second. And remember that is not 10 or 15 OB seconds. (Laughter) This is 1-1,000, 2-1,000, 3 Mississippi, maybe singing Happy Birthday 2 times, whatever. Okay? So, the basic steps, definitely you've got to be good with your pelvic examination. You need to know which way to go, how large it is. And in a heavier-set woman, it may be difficult on bimanual, so I suggest that you might even try a rectal examination there because you can loop your finger up and see where the uterus is and how big it is. Open the speculum wide enough, but some people have suggested that unless she has a lot of pelvic relaxation, use a shorter-blade speculum so that you are not pushing the uterus further and further away from you with a longer-bladed one. If you have a nice tenaculum like the Goldstein -- we call them grippers, but they are probably cervical stabilizers -- with really thin blades that don't overlap... How many of you have been there when it takes longer to stop the bleeding from the tenaculum site than it did to put the whole thing in? Yes? But if we have these little tiny, tiny little grippers okay, and that is just one brand name, but what you are looking for is not thick blades, you are looking that they don't overlap -- you can really minimize that, and it is a lot more comfortable for her. And, of course, the use of Os Finders to help dilate gently and progressively can really save the day and make it so much more comfortable for her. We always want to sound the uterus to measure the depth and make sure that we can set the flange so that we don't perforate. We know that we can place an IUD at any time in the menstrual cycle if we know that she is not pregnant. And efficacy is immediate, right? If she had sex last night, as an emergency contraception, if she gets romantic after -- with the cramping, I don't know (laughter) -- but she can have it tomorrow night and she doesn't, but the LNG IUS we definitely need to protect her against pregnancy for 7 days if we are not doing it in the first couple of days overall. Now, the Bayer Healthcare has harmonized the labeling of both of the LNG IUSs that it makes, and it says do not place before 6 weeks post partum. So, you and I are doing these things immediately postpartum and we are doing them before she runs out of Medi-Cal. Realize that is off label, and make sure you document that she really is well involuted. So, we talked about the two, we talked about that overall. So again, comparative placement in the first 6 to 48 hours postpartum halted because it was higher expulsion rate, but in the first 10 minutes all of the authorities say take out the placenta, put in the IUD ReachMD Page 12 of 15

13 Managing bleeding, non fundal position unless it is in the lower uterine segment or a part of the IUD is in the cervix, leave it be. We already talked about PID. And missing strings in a nonpregnant woman, you can visualize it. If you want to on ultrasound make sure she has not perforated it and she can maintain it if she wants to. So, the big issue is management of the bleeding, and rule out pregnancy, rule out partial expulsion. If she is bleeding heavily, then we have to stop the bleeding and give her iron if she needs it, but we don't need to do a routine ultrasound unless there is a problem. The bleeding, antifibrinolytics and antidiuretic therapies, we usually start with NSAIDs, don't we? And we treat her with the same things that we do for heavy menstrual bleeding normally, and that would be 800 mg of ibuprofen every 8 hours for up to 5 days, and that usually halts it very nicely, and she can keep doing it again. And unfortunately, that did not improve continuation rates. Actinomyces-like organisms, unless she has evidence of actinomyces infection, there is no reason to treat her or to remove the IUD. We have talked about the non fundal. So, the CDC has put out some wonderful guidance on all contraception. As you know, the USMEC and the Selective Practice Guidelines have completely revolutionized the way we offer contraception. We don't have to take care of everything else that she needs for women's healthcare. If she comes in for contraception, we can deal with that and separate it from well woman care. So, again, define the patients that have conditions. You know, I know you know these colors, so we are using these as a basis. And heads up, they have just had another Committee meeting and we're going to get a whole new revision on these hopefully next year, but remember that is CDC time. Okay, so you've got a 28-year-old woman who's pregnant and is counseled for postpartum family. She doesn't plan to breastfeed but does desire effective contraception. Can she get something after delivery? Absolutely. Right? We can give her a copper IUD. We can give her a pill or a patch or an injection or an implant, but we can't give her hormonal contraception yet because we know we want to pay attention to this. And I don't know if you know this or not, but the State of California Medicaid just changed the regulations. We can provide immediate postpartum IUDs and implants to our Medicaid patients. And what they are allowing us to do is bill an outpatient procedure code for an inpatient procedure, so let all your hospitals know that. You can do that and you don't have to wait until she doesn't come back for her postpartum visit. Okay, postpartum VTE, we know that women who have risk factors we want to wait at least 6 weeks before we give them anything estrogen, and these are the guidelines that make the difference. We have to know what those are. IUD placement, we say within 10 minutes of the delivery of the placenta, it's a category 1 or 2. Right? It really works well. And the systematic review shows the expulsion rates are, particularly after an elective C-section, virtually zero, so feel free to pop those in. Make sure the 2018 ReachMD Page 13 of 15

14 tail strings are out the vagina when she does it. In lactating women, this was the study that we talked about. We realize that they are at higher risk. We don't quite know why. People say it is estrogen deficiency, but we don't have a real good explanation for it. We know that IUDs don't cause PID. We've already discussed that. She has to go get it herself. So, in summary, there are 4 intrauterine devices that are available now in the United States, and stay tuned, we are going to get some more choices coming out quickly, that we have safe, effective, longacting and reversible contraception with high continuity and satisfaction rates. We have a lot more flexibility, and we want to meet her need today when she comes in for us. Now, I'm just going to take half a second and give you hot off the press update. This came out last week, and it was from the National Campaign for Preventing Teen and Unintended Pregnancies. And what they learned was that women, we not only should not use the word LARC, don't say long-acting, and do not lump together IUDs and implants. They don't know the difference. What they are beginning to do is calling When we lump them, they lump them, and they call them the invasive contraceptives. So, they have categories like stuff you can get at the store, hormonal, right? And the stuff you get at the store, of course, is natural. (Laughter) Okay? And now we are emerging with this thing that they are calling invasive methods. We do not need that image, do we? So, they want to know what the side effects, and mostly they want to know what they are going to feel while they have them, and they are afraid that they're going to feel the IUD inside the uterus, that the partner will feel it. And it's fascinating with the implant -- I apologize for running late -- but with the implant, how many of us have reassured her touching our arms and demonstrating you'll be able to feel that it is there. How many of us remember that? That was supposed to be reassuring. She is thinking when we say that that as she walks around she will feel this thing inside her arm. Isn't that amazing? So, we need to tell her when you are walking around, you won't feel anything, but when you touch your arm, your fingers will be able to tell where it is. Isn't that cool? So, we are creating some of these images rather inadvertently, and if we can avoid that and use the words like placement instead of insertion, I think that that can go along way to diminishing the invasive category of this. Thank you all so very much. (Applause) Narrator: 2018 ReachMD Page 14 of 15

15 Thank you for listening to the Omnia Education presentation of Intrauterine Contraception: A First-tier Choice Throughout the Female Reproductive Life Cycle. If you want to ask a question, please click on the link following the activity posttest ReachMD Page 15 of 15