Presentation Notes: Emergency contraceptives:, Are regular contraceptives used in a different way, Prevent pregnancy after intercourse, Inhibit ovulation, fertilization, or implantation, Do not cause an abortion, Will not interrupt an established pregnancy, Are not the same as mifepristone, Do not protect against STIs

Presentation Notes: EC options available in the US today:, Emergency use of oral contraceptive pills containing estrogen and progestin, Emergency use of oral contraceptive pills containing only progestin, Emergency Copper-T IUD insertion

Presentation Notes: Combined ECPs contain the estrogen ethinyl estradiol and the progestin levonorgestrel or norgestrel., A dedicated combined ECP product called Preven was on the market in the US from 1998 until 2004., There are currently 22 brands of combined oral contraceptives that can be used as ECPs in the United States., This regimen is also sometimes referred to as the Yuzpe regimen, after the Canadian physician who first described it.

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Presentation Notes: Progestin-only ECPs have replaced combined oral contraceptives as the preferred method of EC in the US. , Plan B® is the only dedicated product in the US, and has been on the market since 1999., The progestin-only oral contraceptive pill Ovrette is no longer marketed in the US.

Presentation Notes: Progestin-only ECPs have replaced combined oral contraceptives as the preferred method of EC in the US. , Plan B® is the only dedicated product in the US, and has been on the market since 1999., The progestin-only oral contraceptive pill Ovrette is no longer marketed in the US.

Presentation Notes: The Copper-T IUD is another form of emergency contraception available in the US., To be used as EC, the Copper-T IUD must be inserted within 5 days of the instance of unprotected sex., Although it is an extremely effective form of EC and can provide contraception for an additional 10 years after insertion, not all women are good candidates for IUDs.

Presentation Notes: The development of post-coital contraception began in the 1920s, when it was first discovered that high-dose estrogens interfered with pregnancy in mammals., The first published study of this application in humans was in the mid-1960s in the Netherlands: high-dose estrogens were administered to a 13-year-old girl who had been raped., In the early 1970s, combined estrogen-progestin doses began to be used – this became known as the Yuzpe regimen, named after Canadian physician Albert Yuzpe who first described the method in 1972., In the late 1970s, the Copper-T IUD began to be used as emergency contraception., Although studies that looked at using oral contraceptives containing the progestin levonorgestrel as ECPs began in the 1970s, this didn’t become standard practice in the US and Europe until the mid-1990s. , Recent studies have examined the use of antiprogestins (specifically mifepristone and CBD 2914) as ECPs.

Presentation Notes: Strategies to improve the use of EC include:, Marketing dedicated products or off-label uses of existing products to be used as emergency contraceptives, Change provider practices to increase their own awareness of EC and ability to educate patients about EC, Take steps to increase the availability of EC by establishing call-in prescription services, enhancing pharmacy access, and/or changing ECPs from prescription-only to over-the-counter for women and men of all ages, Educate the public about EC

Presentation Notes: Until 1999 the only progestin-only regimen available for use as an emergency contraceptive was 20 Ovrette pills followed by 20 more pills 12 hours later., Ovrette is no longer available in the U.S. , ,

Presentation Notes: ACOG Practice Pattern on ECPs (12/96) established the professional standard of care, FDA notice in Federal Register on ECPs (2/97) declared 6 (now 22) brands of regular OCs to be safe and effective for use for emergency contraception, FDA explicitly approved Preven and Plan B as dedicated products, but FDA still recognizes 22 brands of regular combined OCs to be safe and effective for use for EC

Presentation Notes: Emergency contraception (EC) is a therapy for women who have had unprotected sexual intercourse, including sexual assault, and want to avoid pregnancy. The two most common reasons for seeking EC are failure of a barrier method (usually condoms) and failure to use any contraceptive method. This presentation discusses the clinical issues related to emergency contraception. By the end of this presentation, participants should be able to:, Understand progestin-only ECP product regimen,Identify mechanism of action of ECPs, Understand link between EC and risk-taking behavior

Presentation Notes: Participants should also be able to:,State the effectiveness of ECPs, Understand how to begin contraception after ECPs, Understand how to enhance the availability of EC

Presentation Notes: Plan B is the dedicated progestin-only ECP product available in the United States. Two studies have shown that both doses of Plan B (both Plan B pills) can be taken at the same time, With no reduction in effectiveness, With no increase in side effects, One study has shown that two doses of Plan B taken 24 hours apart are just as effective as doses taken 12 hours apart, Two studies have shown that Plan B is effective up to 120 hours after intercourse

Presentation Notes: EC may theoretically prevent pregnancy through several mechanisms. The two leading theories which have been the most intensively studied are inhibition of ovulation and prevention of implantation through disruption of the endometrium. Other possible mechanisms include:,Trapping of sperm in cervical mucus, Inhibition of tubal transport, Direct effects on the viability of the embryo. There has been little specific human research on these last three mechanisms, however, and thus no direct evidence exists to support or refute them. Specifically, theories of post-fertilization effects of EC cannot be studied because there is no test for fertilization itself. Today therefore I will only review the data related to effects of the regimen on ovulation and on the endometrium.

Presentation Notes: We know from the clinical evidence that progestin-only ECPs can:, Inhibit or delay ovulation, Alter glycodelin in serum and endometrium (but the clinical significance of this finding is unknown), Shorten or lengthen the next menstrual period, depending on when in the cycle ECPs were taken, Interfere with sperm motility and function in the genital tract by altering uterine pH

Presentation Notes: We know that LNg ECPs can inhibit ovulation, but does not always do so even when given before ovulation. Inhibiting ovulation may be the only mechanism of action. The evidence regarding the effect of LNg ECPs on the endometrium is mixed and is hard to interpret - older studies seem to show profound effects, but more recent studies do not. It’s unclear also whether the effects that are seen are sufficient to prevent implantation.One study has also shown incidentally that the regimen may affect levels of various hormones, but again exactly how these changes prevent pregnancy is unclear.

Presentation Notes: Study done in the rat and the Cebus monkey, Levonorgestrel administered in doses that inhibit ovulation has no postfertilization effect that impairs fertility

Presentation Notes: Based on what we know about the mechanisms of action for ECPs, hormonal contraceptives, IUDs, and the contraceptive effects of breastfeeding – all of these methods may prevent a fertilized egg from implanting in the uterine lining and becoming a pregnancy.

Presentation Notes: Talking Point, ECPs—like all regular hormonal contraceptives such as the birth control pill, the implant Implanon, the vaginal ring NuvaRing, the OrthoEvra patch, and the injectable Depo-Provera, and even breastfeeding—may prevent pregnancy by delaying or inhibiting ovulation, inhibiting fertilization, or inhibiting implantation of a fertilized egg.

Presentation Notes: Women should be informed that the best available evidence is consistent with the hypothesis that Plan B’s ability to prevent pregnancy can be fully accounted for by mechanisms that do not involve interference with post-fertilization events.

Presentation Notes: Studies have been conducted around the world to examine whether ECPs impact risk-taking behavior. We have empirical evidence from 1 study in Scotland, 3 in San Francisco, 1 in Pittsburgh, 1 in Hong Kong, 1 in China, 2 in Los Angeles, and 1 in Nevada & North Carolina; results from each of these studies can be found in the appendix of this presentation.

Presentation Notes: Talking Point, In these studies, women were randomized to receive either: (1) counseling and access to ECPs on demand, or (2) ECPs in advance for later use should the need arise.

Presentation Notes: In Nevada and North Carolina: 71% of women receiving ECPs in advance used them versus 32% of women who received only counseling (p<.001), 2 studies in Los Angeles found that women who received ECPs in advance were more likely to use them than women who received only counseling:,86% vs 11% at 6 months and 64% vs 17% at 12 months in Study 1 (p<.01), 19% vs 12% in Study 2 (p<.05), In Hong Kong: 30% of women receiving ECPs in advance used them versus 13% of women who received only counseling (p<.001), In Pittsburgh: 15% of women receiving ECPs in advance used them versus 8% of women who received only counseling (p<.05), 3 studies in San Francisco found that women who received ECPs in advance were more likely to use them than women who received only counseling:,22% vs 7% in Study 1 (p=.006), 17% vs 4% in Study 2 (p=.006), 37% vs 21% in Study 3 (p<.001), In Scotland: 47% of women receiving ECPs in advance used them versus 27% of women who received only counseling (p<.001),

Presentation Notes: Women who received ECPs in advance were not more likely to:, Use ECPs repeatedly, Have unprotected sex, Change to less effective contraception, Use contraception less consistently, Acquire an STI (in the three studies that measured STIs)

Presentation Notes: Women who received ECPs in advance:, Took ECPs sooner after sex, Had the same contraceptive use patterns as women who received counseling and had access to ECPs on demand, HOWEVER, women who received ECPs in advance were also NOT less likely to become pregnant as women who received only counseling and had access to ECPs on demand.

Presentation Notes: In August 2006, James Trussell, Elizabeth Raymond and Chelsea Polis systematically reviewed data on effects of increased access to emergency contraceptive pills on pregnancy rates and use of the pills. Data sources included MEDLINE, POPLINE, EMBASE, and LILACS, and study authors consulted with experts. Authors included studies that compared the effect of different levels of access to emergency contraceptive pills on pregnancy rates, use of the pills, and other outcomes. Eight of the ten studies conducted to test whether easy assess to ECPs increased risk taking also measured pregnancies, In none of the eight did advance provision of ECPs reduce pregnancy rates, However, only three studies were powered to detect a decrease in pregnancy rates,

Presentation Notes: In San Francisco almost half of the women in the advance provision group who had unprotected intercourse did not use ECPs, In China, 30 of the 38 pregnancies in the advance provision group occurred to women who did not use ECPs in that cycle, In Nevada/NC, 57 of the 74 pregnancies in the advance provision group occurred to women who did not use ECPs in that cycle, Note that only three trials were designed to study the impact of increased availability of ECPs on pregnancy.

Presentation Notes: In Scotland:,About 1 in 5 women aged 16-29 got ECPs in advance to take home, About half of these used ECPs at least once

Presentation Notes: In Scotland:,No effect on abortion rates was observed, 78% of women with advance supplies who got pregnant did not use ECPs. Women most at risk probably did not get ECPs

Presentation Notes: Two trials in which women were randomly assigned to Plan B or Yuzpe regimen. Pregnancy rate in Plan B arm was 51% of the rate in the Yuzpe arm. Plan B is 49% effective if Yuzpe regimen is completely ineffective. If, for example, Yuzpe regimen is 60% effective, then Plan B is 79% effective.

Presentation Notes: Women underestimate their risk of pregnancy, More education is needed, OTC switch is necessary – but not sufficient – for solving this problem, Major public health impact is unlikely, ECPs are not used frequently enough.

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Presentation Notes: Jump-starting contraception after taking EC provides better pregnancy protection,If a woman waits until her next period to start contraception she may have additional instances of unprotected sex and get pregnant

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Presentation Notes: Two studies specifically designed to assess the effects of ECPs containing 1.5 mg levonorgestrel taken in a single dose on bleeding patterns

Presentation Notes: The first study found that when taken in the first three weeks of the menstrual cycle, ECPs significantly shortened that cycle compared both to the usual cycle length and to the cycle duration in a comparison group of similar women who had not taken ECPs.The magnitude of this effect was greater the earlier the pills were taken. This regimen taken later in the cycle had no effect on cycle length, but it did cause prolongation of the next menstrual period. The ECPs had no effect on the duration of the post-treatment menstrual cycle, but the second period was prolonged. Intermenstrual bleeding was uncommon after ECP use, although more common than among women who had not taken ECPs.

Presentation Notes: The second study compared the baseline cycle with the treatment and post-treatment cycles.Cycle length was significantly shortened by one day when ECPs were taken in the preovulatory phase of the cycle and was significantly lengthened by two days when ECPs were taken in the postovulatory phase. No difference in cycle length was observed for women who took ECPs during the periovulatory phase of the cycle (from two days before to two days after the expected day of ovulation). Menstrual period duration increased significantly when ECPs were taken in the periovulatory or postovulatory phase in both the treatment and post-treatment cycles. The duration of the post-treatment menstrual cycle remained significantly longer when ECPs were taken in the postovulatory phase. During the treatment cycle, 15% of women experienced intermenstrual bleeding; this was significantly more common when ECPs were taken in the preovulatory phase.

Presentation Notes: The EC Hotline and Website are operated by the Office of Population Research at Princeton University and by the Association of Reproductive Health Professionals.These resources are not connected with any companies that manufacture or sell emergency contraceptives. The EC Hotline and Website were developed to increase women's knowledge about and timely access to EC. Each month there are about 6,000 calls to the hotline and 120,000 visits to the Web site.

Presentation Notes: The EC Hotline and Website includes hundreds of health care providers in private practice, family planning clinics, hospitals, pharmacies, and other types of health care settings who offer information about and prescriptions for emergency contraception (for females under age 18). www.not-2-late.com,

Presentation Notes: On August 24, 2006, the FDA approved Plan B to be sold without a prescription to women and men 18 and older in the United States. A government-issued ID is required for proof of age to purchase Plan B OTC. When Plan B is purchased OTC, insurance does not longer cover the cost. Women age 17 and younger still need a prescription from a health care professional except in states with pharmacy access,“Pharmacy access” means specially trained pharmacists can decide if EC is medically appropriate for the woman requesting it and can dispense ECPs without an advance prescription in those cases. No proof of age is necessary in those states. States that currently have pharmacy access in place: AK, CA, HI, NH, NM, MA, ME, MT, VT, and WA.

Presentation Notes: In states with pharmacy access, women and men of any age (including those age 17 and younger) can access ECPs directly from the pharmacy, without a prescription. “Pharmacy access” means specially trained pharmacists can decide if EC is medically appropriate for the woman requesting it and can dispense ECPs without an advance prescription in those cases. No proof of age is necessary in those states. States that currently have pharmacy access in place: AK, CA, HI, NH, NM, MA, ME, MT, VT, and WA. Several countries also allow access to ECPs directly from a pharmacist without a prescription. www.not-2-late.com,

Presentation Notes: This map shows the current locations of pharmacies in states with pharmacy access to ECPs, regardless of age. www.not-2-late.com,

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Presentation Notes: Ovulation may occur w/in 7–10 days post-procedure, Emergency contraception should be dispensed with instructions for use, Hormonal contraceptives can be started immediately, IUD may be inserted immediately post-procedure,

Presentation Notes: Tubal ligation can be performed post-procedure or scheduled; an interim contraception plan should be developed, A barrier contraceptive should be used with first intercourse and continued, unless another contraceptive method is selected, and/or the patient is at risk for STIs

Presentation Notes: Ovulation may occur within 7–10 days after abortion, Emergency contraception should be dispensed with instructions for use, Hormonal contraceptives can be started at or before follow-up visit:, Oral contraception, hormonal patch, or vaginal ring—the woman can be provided with prescription and directions to start on an agreed upon date after she has passed the POC but before she returns for follow up, Depo Provera—woman can receive injection at follow-up visit, IUD may be inserted when abortion is confirmed at follow up ultrasound or when successful abortion is confirmed and pelvic exam is normal

Presentation Notes: Ovulation may occur w/in 7–10 days post-procedure, Emergency contraception should be dispensed with instructions for use, Hormonal contraceptives can be started immediately, IUD may be inserted immediately post-procedure,

Presentation Notes: Tubal ligation can be performed post-procedure or scheduled; develop interim contraception plan, Barrier contraceptive use with first intercourse

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Presentation Notes: At the end of this presentation participants should be able to:, Understand the history of tubal sterilization, List pros and cons of transcervical sterilization, Review findings of micro-insert clinical trials,

Presentation Notes: By the end of this presentation participants should be able to:, List at least 4 methods of transcervical permanent contraception, Identify subgroups of women most likely to experience regret after tubal sterilization

Presentation Notes: This chart illustrates the contraceptive method used by US women ages 15-44 (62%) - an estimated 38% of women of reproductive age do not use a contraceptive method, for various reasons., Female sterilization outnumbers male sterilization 3 to 1 as a chosen contraceptive method: the 23% in this chart breaks down to 17% female sterilization and 6% male sterilization., Sterilization is the most popular form of contraception used by US women of reproductive age who are trying not to become pregnant., Other non-hormonal contraceptive methods include the TodayTM sponge, cervical cap, diaphragm, female condom, and spermicide., Other hormonal contraceptive methods include the ImplanonTM implant, LunelleTM monthly injectable, and the contraceptive patch.

Presentation Notes: This chart illustrates the contraceptive methods used by the 38,109 US women ages 15-44 who practice contraception (62% of all women of reproductive age)., Again - female sterilization outnumbers male sterilization 3 to 1 as a chosen contraceptive method: the 36% in this chart breaks down to 27% female sterilization and 9% male sterilization., Sterilization is the most popular form of contraception used by US women of reproductive age who are trying not to become pregnant., Other contraceptive methods include the TodayTM sponge, cervical cap, diaphragm, female condom, spermicide, the ImplanonTM implant, LunelleTM monthly injectable, the contraceptive patch, withdrawal, natural family planning, emergency contraception, or some other method.

Presentation Notes: In the United States, the popularity of tubal sterilization rose dramatically in the 1970s, from 200,000 per year in 1970 to over 700,000 per year by 1977., This chart provides a visual picture of the numbers of tubal sterilizations performed in the United States annually between 1970 and 1994., In 2002, over 10,000 women of reproductive age used female sterilization as their chosen contraceptive method.

Presentation Notes: The primary reason why this rise was seen was because of the advent of the laparascope,

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Presentation Notes: Sterilization is very safe, with low mortality rates.,

Presentation Notes: The numbers of complications have a direct correlation to the experience of the surgeon performing the procedure., Data based on annual self-report survey of American Assn of Gynecologic Laparoscopists (AAGL),

Presentation Notes: We have limited data on patient regret., One long-term study that asked this question about tubal sterilization is called the CREST study (United States Collaborative Review of Sterilization)., CREST reports a strong correlation between age and regret. 20% of women in the study who were 30 years of age or younger expressed regret as opposed to only 6% of women over 30.,

Presentation Notes: These values represent the cumulative probability of pregnancy per 1000 tubal ligation procedures., In the parentheses, the first value is the number of subjects, and the second is the number of ectopic pregnancies identified during 10 years of follow-up.,

Presentation Notes: Women have different needs for permanent contraceptive methods,

Presentation Notes: Minilaparotomy—“minilap”—the most common technique, involves abdominal 5 cm incision--generally used in postpartum procedures, Laparoscopy, Laparotomy either for purposes of tubal ligation or at the time of cesarean section ,

Presentation Notes: In a partial salpingectomy the fallopian tubes are cut and tied with suture material. The Pomeroy technique, a widely used version of partial salpingectomy, involves tying a suture around the base of a small loop of the tube and cutting off the top segment of the loop. As the tube heals, the suture is absorbed and the two ends separate. This technique requires no special equipment; it can be performed with only scissors and suture. Any obstetrician/gynecologist, family practitioner, or surgeon with operating privileges can perform this procedure, as can physician assistants in some states., With clips, the fallopian tubes are blocked by clamping down and cutting off the blood supply, causing a small amount of scarring or fibrosis that prevents fertilization from occurring. The two most common clips are the Filshie clip, made of titanium, and the Hulka clip, made of plastic. Clips are easy to use, but each type requires a special applicator. They have the highest rates of tubal reversal because they destroy the smallest amount of Fallopian tube., Silicone rings, like clips, also block the tubes mechanically. A small loop of the fallopian tube (much like the Pomeroy procedure) is created, and the stretched ring is advanced over the loop to the base. When the ring is released, it stops the blood supply to that small loop, with resultant scarring that blocks passage of the sperm or egg. The most common of these is the Falope Ring, although the Yoon ring is also popular. , Electrocoagulation uses electric current to coagulate or burn a small portion of each fallopian tube. Unipolar coagulation passes current through the forceps applied on the tubes, and the current leaves a woman’s body through an electrode placed under her thigh. Because it was associated with sparking, this approach is no longer recommended. In bipolar coagulation, current passes only between the two ends of the forceps. Bipolar coagulation is safer than the unipolar technique, but it is associated with higher ectopic pregnancy rates than the Pomeroy procedure.

Presentation Notes: Electrocoagulation is one type of hysteroscopic sterilization technique,

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Presentation Notes: Endoscope efficiency:, Rod lens, fiberscopes with improved light transmission with high resolution, Continuous-flow technology:, Low viscosity, physiologic solutions, Advanced cardiology technology:, Overwire catheters with hydrophilic coating, Improved tracking of narrow, tortuous lumen, Stent and coil technology,

Presentation Notes: Transcervical sterilization is done on an outpatient basis, There is no need for general or regional anesthesia ,

Presentation Notes: Special equipment (5 mm hysteroscope with 5 FR operating channel) needed for insertion , Special training in technique is required, Women with distorted tubes or uterine cavities may not be candidates, Uncertainty still exists about long-term effectiveness and whether insurance companies will cover these procedures,

Presentation Notes: For women with medical conditions such as heart disease and obesity procedure may be safer, partly because of routine use of local anesthesia, particularly. Some of these women are ineligible for conventional tubal sterilization., Because no incision is necessary, it's less invasive, women have less discomfort and recover faster, and the absence of a scar preserves their privacy.,

Presentation Notes: The need for backup birth control and possibility of experiencing regret are two patient disadvantages to transcervical sterilization,

Presentation Notes: The device is 4 cm long and is both soft and flexible. It is composed of a narrow inner coil and a larger diameter outer coil. Laced along the length of the inner coil is a weave of PET fibers. At full expansion the outer coil can achieve a diameter as great as 2 mm. The leading edge of the device has a small ball tip swelling which facilitates the forward advancement and proper placement of the device into the proximal fallopian tube.,

Presentation Notes: Device is soft and flexible., Composed of a narrow inner coil made out of Stainless steel and a larger diameter outer coil in Nitinol (50% nickel 50% titanium)., Laced along the length of the inner coil is a weave of PET (Polyethylene terephthalate) fibers. These fibers will promote a rapid tissue in-growth during the first 3 months in the Fallopian tube., Full length of the Micro-Insert is 4cm and the super-elastic outer coil expands from a wound-down diameter of 0.8mm to a fully opened diameter of up to 2mm. , Leading edge of the device has a small ball tip swelling which facilitates the forward advancement and proper placement of the device into the proximal fallopian tube., All materials are extensively documented as implantable materials and widely used in cardio-vascular applications.

Presentation Notes: There is a three fold explanation for the Essure device’s mechanism of action: First the expandable outer coil is responsible for acute device anchoring; second the device provides both space filling and mechanical blockage of the tubal lumen; and finally occlusion is achieved as a result of a tissue in-growth from the tubal mucosa into and around the Micro-Insert.

Presentation Notes: After 2 years of clinical testing with the earlier device iterations, clinical testing of the gamma design of the Essure System began in 1998, with testing in hysterectomy patients to obtain data on the feasibility of device placement. Over 40 women were enrolled into this study and the results from this study supported moving into the next stage of clinical testing., At the next stage, the Micro-Insert placement was performed in hysterectomy patients 1-30 weeks prior to a planned hysterectomy. This study yielded the first data on Micro-Insert placement in awake women, as well as the first data on the safety and comfort of the implanted Micro-Insert. This study also provided histological data to support the theorized mechanism of action. Over 60 women were enrolled into this study. , A Phase II study of safety and effectiveness in sterilization candidates was also conducted. This study provided the first safety and effectiveness data in the intended patient population, and over 200 women were enrolled into this study. , Finally, based on the results from the Phase II study, a Pivotal trial was initiated in the year 2000.

Presentation Notes: The objectives of the clinical trial are to evaluate:, Safety and participants’ tolerance of and recovery from Essure procedure, Safety and participants’ tolerance of implanted Micro-Inserts, Tubal occlusion by HSG at 3 months, Effectiveness in pregnancy prevention,

Presentation Notes: Of the 204 women with successful bilateral placement, 97% are occluded at three months. One in six women will not have successful placement and will not be able to use this method. ,

Presentation Notes: Of these 518 women, 11 did not undergo attempted Micro-Insert placement because the tubal ostia could not be visualized. Also, 18 women who did not achieve bilateral placement underwent a follow-up HSG, and 15/18 (83%) were diagnosed with proximal tubal occlusion (PTO).

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Presentation Notes: Average time to discharge was 45 minutes with a lot of variation related to procedure setting. , The recovery room time was completely uneventful in 58% of women, with the remainder having mild events such as cramping, pain or nausea., There was no post procedure analgesia administered in 75% of women, and those requiring it received mainly, or Tylenol with codeine, percocet, tylenol or paracetamol, etc.,

Presentation Notes: This slide shows the percent of women experiencing adverse events related to hysteroscopic placement of Essure.,

Presentation Notes: On the day of device placement, adverse events were noted in 3% of women. All AE’s resolved prior to discharge., None required major surgery. One woman had an adverse reaction to medication given for pain and was observed overnight in the hospital. Perforations resulting from device placement occurred in 5 women (1%) with no resulting adverse symptoms., The majority of women reported none to mild pain during the procedure, most describing it as period type pain, and most had good to excellent tolerance of the placement

Presentation Notes: Of the 329 women who were employed, 74% reported missing less than one day of work following the procedure day, and an additional 18 percent missed one day.

Presentation Notes: Adverse event defined as any untoward deviation from baseline, Daily diaries were maintained for 6 months, Investigators prompted by case report form at each study visit on 2 separate questions in addition to the questions on pain and bleeding., Multiple episodes of the same complaint from the same woman are counted as multiple adverse events, SO for example, one woman in the trial reported 6 episodes of low back pain at the 3-month PDP visit, that is reflected as 6 events in the AE by body system table., The events by body system table reports all events related as possible, probable or definitely related to the device. ,

Presentation Notes: Defined as dysmenorrhea, dyspareunia, ovulatory pain, other pelvic pain, Only 3% reported such episodes at more than one study visit, Only 1 reported episode of pelvic pain at every study visit,

Presentation Notes: Women were also asked about any episodes of irregular bleeding at each study visit. Reports were then categorized as irregular menses, spotting or intermenstrual bleeding, or changes in menstrual flow., Reports of any irregular menses or intermenstrual bleeding decreased from the 3-month PDP visit to the one year visit, and it should be noted that the one year visit covered a six-month reporting timeframe. , Less than 10% of women reported these events at more than one visit , Only 2 women reported intermentstrual bleeding at all study visits, Nine women reported an increase in menstrual flow, Eight women reported a decrease in menstrual flow, All of the menstrual function changes and pelvic pain have to be considered in light of the fact that 48% of women discontinued the use of oral contraceptives after the alternative contraception period.,

Presentation Notes: Phase II 1-Year Failure Rates: 95% CI 0-0.45%; Adj 95% CI 0-0.64%*, Pivotal Trial 1-Year Failure Rates: 95% CI 0-0.27%; Adj 95% CI 0-0.31%*, Both Trials Combined Failure Rates: 95% CI 0-0.17%; Adj 95% CI 0-0.21%*, Phase II 3-Year Failure Rates: 95% CI 0-1.34%; Adj 95% CI 0-2.04%*, Pivotal Trial 3-Year Failure Rates: 95% CI 0-0.82%; Adj 95% CI 0-0.86%*, Both Trials Combined Failure Rates: 95% CI 0-0.51%; Adj 95% CI 0-0.60%*, *Adj. Using indirect method, adjusted to CREST study population based on 3 age groups,

Presentation Notes: In two clinical studies of Essure involving over 600 patients who relied on Essure for at least one year, there were no observed pregnancies., The effectiveness rate of Essure at one year is calculated to be at least 99.5%., This effectiveness rate means that although no pregnancies were observed in the Essure clinical trials, in a similar population of this size and with a follow-up duration of one year, there is at most a 0.5% chance that a pregnancy could occur., There were 4 luteal phase pregnancies prior to device placement. Of these:, One ended in spontaneous abortion, One was terminated with mifepristone, Two underwent a dilation and curettage (d & c) procedure,

Presentation Notes: Highly effective, Very high patient satisfaction, Well-tolerated placement procedure, Rapid return to work and normal activities, Comfortable and safe, No requirement for general anesthesia, No requirement for incisions,

Presentation Notes: Patients need to use another contraceptive method for 3 months after insertion, HSG is done at 3-month follow-up appointment, Patients need to know that they should notify any health care professionals about their microinsert prior to any intruterine procedures.,

Presentation Notes: There are other transcervical sterilization methods in development,

Presentation Notes: Quinacrine is one of the most widely studied chemicals for nonsurgical female sterilization,

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Presentation Notes: The antibiotic erythromycin is being studied for its ability to create scar tissue that permanently occludes the fallopian tubes.,

Presentation Notes: Intratubal ligation devices also cause scar tissue in the tubes to create permanent occlusion,

Presentation Notes: Catheter inserted into fallopian tube, Creates superficial lesion using bipolar low radio-frequency energy, Porous non-biodegradable implant is inserted in lesion, Currently in clinical trials,

Presentation Notes: Counsel patients on the side effects, failure rates, and recovery related to the contraceptive methods that are most appropriate for them, Also explain the methods that are not appropriate for them,

Presentation Notes: Thoroughly explain to the patient what is involved with permanent contraceptive options,

Presentation Notes: Explain the medical benefits and risks to patients about their chosen contraceptive method,

Presentation Notes: These characteristics make a woman more at risk for regret after sterilization.

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Presentation Notes: At the conclusion of this session, participants should be able to: Name the two forms of intrauterine contraception available in the United States, Rank efficacy associated with intrauterine contraceptives compared with other contraceptive methods, List three selection criteria for appropriate candidates for intrauterine contraception

Presentation Notes: At the conclusion of this session, participants should be able to: Identify two possible side effects of each type of intrauterine contraceptive, Develop skills required for proper insertion techniques for the two methods of intrauterine contraception, Discuss strategies for follow-up of intrauterine system users

Presentation Notes: The first version of the modern intrauterine contraceptive was developed in 1909 by a German gynecologist and sex researcher named Ernst Grafenberg. It was a ring-shaped device made of silver wire and silkworm gut. It wasn’t widely used until the 1920s. Plastics became widely available in the 1950s and became very useful in the development of new forms of intrauterine contraception. A flurry of activity at The Population Council resulted in the First International Conference on Intrauterine Contraception in 1962, where Drs. Marguiles and Lippes introduced the intrauterine plastic spiral and intrauterine plastic loop. 1964: Bernard Berelson, vice president of The Population Council, at the Second International Conference states, “This simple device can and will change the history of the world.”, 1967: Scientist at The Population Council developed "T" shaped device. Since 1960, nine intrauterine contraceptives have appeared on the US market.

Presentation Notes: 1968: Contraceptive action of intrauterine copper is reported. 1976: Copper T 200 becomes the first Copper T IUD. The Population Council worked with FEI Women’s Healthcare LLC to refine the IUD design to increase contraceptive duration and effectiveness. This research resulted in the Copper T 380A, which has copper collars on the arms and copper wire coiled around the stem. 1980: Levonorgestrel (LNG) IUD (commonly referred to as an intrauterine system or IUS) is tested in randomized clinical trials.

Presentation Notes: The copper T IUD (brand name ParaGard®) was approved by the Food and Drug Administration (FDA) in 1984 and has been available for use in the United States since 1988. Since 2005, DuraMed Pharmaceuticals, Inc. a division of Barr Pharmaceuticals, Inc. has marketed ParaGard. In 2000, the levonorgestrel (LNG) IUD (brand name Mirena) became available in the US. It is marketed by Berlex Inc.

Presentation Notes: The US abortion rate declined 5% between 1996 and 2000, reaching the lowest rate since 1974. The number of abortion providers also declined. With more than one in five US pregnancies ending in abortion, women are becoming pregnant more often then they desire—these are, by definition, unintended pregnancies that could have been prevented by effective contraception. The US has a higher rate than found in many western European countries, but within the range of a few other developed countries such as Sweden and Australia.

Presentation Notes: Many women who select sterilization at a young age later express regret. Many of these women choose sterilization because they don’t know that equally effective reversible options exist.

Presentation Notes: There is a need for contraceptive methods that are forgettable.

Presentation Notes: Myths exist about intrauterine contraception: Many believe IUDs are not safe. Many believe IUDs are not appropriate for nulliparous women. Many believe IUDs cannot be used in women who have had an ectopic pregnancy. According to the results of a survey of consumer and provider Web sites, many sites carry inaccurate or outdated information about intrauterine contraception: One-half of the sites surveyed depict the IUD as increasing the risk of pelvic inflammatory disease, or PID (not just in the first few weeks), Two-thirds of the sites say the device heightens risk for ectopic pregnancy, One-quarter of the sites portray use of the method as a risk for infertility

Presentation Notes: This presentation is grouped into the following chapters and sections: Contraceptive Use, Overview of Intrauterine Contraception, Patient Screening and Counseling for IUDs, IUD Insertion and Management, Throughout the slide set, the abbreviation “IUD” for intrauterine device refers to both the copper T IUD and the levonorgestrel-releasing IUD, unless one or the other is specified.

Presentation Notes: Talking Points
Unintended pregnancy continues to be a major public health issue in the United States. In 2002, nearly half of the 6.4 million pregnancies in the United States were unintended.
Almost half of unintended pregnancies end in elective abortion.

References
Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006;38:90-6.

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Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March 2007. Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. This slide is available at www.arhp.org/core.

Presentation Notes: NOTE TO SPEAKER: This question can be posed to the audience to make the presentation interactive.

Presentation Notes: NOTE TO SPEAKER: This case study can be used to launch an interactive discussion with the audience about common misconceptions and barriers to IUD use. You might present the case and then give the audience a break to come up with reasons why the woman doesn’t return for insertion—for example, she may have fears about the IUD causing infertility or about having a foreign object in her body, she may think it is larger than it actually is, she may get pregnant again, etc.

Presentation Notes: IUDs are the most popular form of reversible contraception used worldwide. The population listed here—women currently married or in a union using family planning, ages 15–49—is the population that is most suited for IUD use, but only a very small percentage of women in North America use IUDs. Today, the rate of use in the United States is 2%, rather than the 1% listed here. Still, among all contraceptive users in the United States, IUDs are used far less often than sterilization. The opposite is true in other countries.

Presentation Notes: NOTE TO SPEAKER: This question can be posed to the audience to make the presentation interactive.

Presentation Notes: This slide shows the percentage of female ob/gyns (18%) who, when surveyed, said they would choose an IUD as their method of contraception if they needed birth control vs. use of IUDs in the general population (0.7%). Women physicians were ACOG fellows (N=301). Despite the low use of IUDs among US women, those who use IUDs are highly satisfied with the method. Almost all—99%—say they are “very satisfied” or “somewhat satisfied” with IUD use (Forrest JD).

Presentation Notes: NOTE TO SPEAKER: This question can be posed to the audience to make the presentation interactive.

Presentation Notes: The majority of residents responding to a 1995 survey of program directors and chief residents at 244 family medicine residency programs in the United States reported they had no clinical experience in IUD insertion and removal. 31% of chief residents and 22% of program directors reported no oral instruction about IUDs. 43% of chief residents at family practice programs received no training in IUD insertion; 41% received no removal training. A mailed survey of 811 practicing ob/gyns (all ACOG members) shows that ob/gyns insert few IUDs because of myths about IUD safety and fear of litigation. Other reasons for the under-use of IUDs in the US include: Negative publicity about older methods, Misconceptions among providers & public, Fear of litigation, Upfront cost for patient and provider, Lack of awareness of method among women

Presentation Notes: A British study, which used structured interviews with 10 women of varying ages and parity who had never used an IUD but had used contraception in the past 6 months, found five main themes that make women IUD non-users: Lack of objective information about IUDs, Reported side effects, Anxiety about IUD insertion (including worries about mess and embarrassment during the fitting), Risk of infection, Lack of personal control of the IUD once it is inserted (i.e. concern that the hidden nature of the IUD might mean it was unreliable)

Presentation Notes: A study of 190 women ages 14–25 presenting for prenatal or abortion care inquired about contraceptive history, plans, and knowledge. The majority of subjects wanted to postpone another pregnancy for 4 or more years and wanted a safe and effective method of contraception to reach this goal. The women were 20 years old on average, 27% had education past high school, and 47% had delivered a child. Ninety-one percent had not planned their current pregnancy. Fifty percent had heard of intrauterine contraception, 71% did not know about its safety, and 58% did not know about its efficacy. Respondents who knew of IUDs were older (21 vs. 19 years, P<0.001) and more likely to be parous (55% vs. 39%, P=0.04). The study suggests that “young women choosing contraception after a pregnancy would benefit from counseling about the relative safety and efficacy of IUDs, allowing them to make fully informed contraceptive choices.”

Presentation Notes: Highest patient satisfaction among methods: Patients who use IUDs are most satisfied with their method compared with other methods. IUD use allows spontaneity. Rapid return of fertility: Patients who use IUDs have a rapid return of fertility after removal of the device. Safe: IUDs are safe. Complications are rare. Immediately effective: IUDs protect against pregnancy immediately after insertion. Long-term protection: IUDs can be used for 5–10 years, Highly effective: The efficacy of IUDs is comparable to that of sterilization.

Presentation Notes: LNG IUD: Currently marketed as Mirena® by Berlex, Inc. Approved for 5 years of use; data demonstrate 7-year efficacy. Approved by the FDA in 2000; has been used in Europe since 1990. Copper T IUD: Currently marketed as ParaGard® by Duramed Pharmaceuticals, Inc. T-shaped polyethylene and copper unit. Approved for 10 years of use; data demonstrate 12-year efficacy. Approved by the FDA in 1984, marketed in 1988. A progesterone-releasing IUD (Progestasert®) was on the market in the United S from 1976 until 2001.

Presentation Notes: IUDs are not abortifacients; they prevent fertilization. IUDs do not increase the risk of ectopic pregnancy; rather, they decrease the risk of both ectopic and intrauterine pregnancy. However, IUDs are more efficient at preventing uterine than ectopic pregnancy, so that compared with other methods, a higher fraction of pregnancies that occur with an IUD are ectopic. A survey of ob/gyns shows that although attitudes toward the safety and effectiveness of the IUD are very positive, most respondents believe that a long-term causal relationship exists between the modern copper T IUD and PID. The truth is that IUD use, in properly selected patients, does not increase the risk of PID. Untreated pelvic infection is the most common cause of infertility; IUD use is not associated with infertility. The 2001 New England Journal of Medicine article by Hubacher et al. as well as others, confirms the overall benign impact on women who use copper IUDs. Some women are hesitant to use the IUD because they perceive it to be larger than it actually is. In truth, both types of IUD are small and can fit in the palm of the hand.

Presentation Notes: A 4-year study found that IUD failure and expulsion rates were lower for nulliparous than parous women. Another study that evaluated three types of IUDs in nulliparous women found low failure and expulsion rates. According to the World Health Organization’s Medical Eligibility Criteria for Contraceptive Use, nulliparity is considered a condition for which the advantages of using an IUD generally outweigh the theoretical or proven risks. IUD use in women with a previous ectopic pregnancy is appropriate but reflects off-label use. IUD users who develop an STI or PID should be tested for relevant organisms and treated with appropriate antibiotic therapy. Clinical guidelines state that removal of the IUD is not necessary unless symptoms fail to improve within 72 hours of the start of treatment. Actinomyces-like organisms (ALO) normally exist in the female genital tract and are sometimes identified on Pap tests. Current recommendations state that symptomatic women with a finding of ALO from a Pap or other test should be treated with appropriate antibiotics and the IUD should be removed (after the patient has begun antibiotics). Asymptomatic women require neither IUD removal nor antibiotic therapy.

Presentation Notes: The exact mechanism of action of the copper IUD is not clear; however, substantial evidence suggests that the primary mechanism of action is prevention of fertilization. Inhibition of implantation would explain the high effectiveness of copper IUDs to act as emergency contraception.

Presentation Notes: The mechanism of action of the levonorgestrel intrauterine contraceptive is similar to that of LNG implants or LNG-containing mini-pills. Thickening of the cervical mucus and inhibition of sperm motility and function are the primary mechanism of action. The endometrial atrophy that is a consequence of the high endometrial levels of LNG leads to a substantial decrease in menstrual flow and absence of bleeding in some women who use this form of intrauterine contraception. It is important to some patients that the LNG IUD mechanisms of action are all before conception. It prevents fertilization rather than disrupts implantation (a common misconception). The low ectopic pregnancy rate relative to pregnancy rate suggests that an anti-implantation effect is not the primary contraceptive mechanism of action of the device.

Presentation Notes: In a study designed to recover ova from the fallopian tubes of 56 women using IUDs and 115 women using no contraception, 20 controls and 14 IUD users had coitus during the preovulatory period of the study. IUDs studied included copper T 200 (4 women), Lippes loop (5 women), and progestin IUDs (5 women). Microscopic features indicative of normal preimplantation development were observed in 50% of the ova from controls but in 0% of the ova recovered from IUD users. Sixty-four percent of the eggs recovered from the IUD group showed no signs of development, as did 15% of the eggs recovered from the control group.

Presentation Notes: Because the intrauterine contraception failure rate is comparable to that of sterilization, it could be viewed in this context as reversible sterilization, not just reversible contraception.

Presentation Notes: First-year failure rates of reversible contraceptive methods and of no contraceptive use are indicated in the chart. For the LNG-IUD, perfect use = typical use. For the copper T IUD, perfect use has a slightly lower failure rate of 0.6%.

Presentation Notes:

Presentation Notes: The presence of a preexisting sexually transmitted infection (STI) at time of insertion, not the IUD itself, increases the risk of PID.

Presentation Notes: Longer duration of IUD use is associated with a lower rate of pelvic inflammatory disease. Among approximately 20,000 women using the device for 21 days to 8 years, incidence of the disease was approximately 1 per 1000 woman-years, as opposed to a rate of nearly 10 in 1000 woman-years among women using the IUC for 20 days or less.

Presentation Notes: As shown in case-series reports, there is no increase in the incidence of birth defects in infants born at term with a copper or progesterone IUD left in place for the duration of the pregnancy. There are no data for the levonorgestrel intrauterine contraceptive. In a case-control study reported by the Centers for Disease Control and Prevention, IUDs left in place during pregnancy were not associated with an increased incidence of limb reduction defects in infants. This evidence suggests that there is no causal association between the retention of an IUD during pregnancy and an increased risk of birth defects.

Presentation Notes: Background: Previous studies of IUDs, many no longer in use, suggested that copper IUDs might cause tubal infertility, decreasing the use of this method in nulligravid women. Hubacher et al. enrolled 1,895 women in a case-control study: 358 women with primary infertility with tubal occlusion documented by hysterosalpingogram, 953 women who were infertile without tubal occlusion (infertile controls), and 584 primigravid women (pregnant controls). Information was obtained about the women’s past use of contraceptives including copper IUDs, previous sexual relationships, and history of STIs. Each subject had antibody testing for Chlamydia trachomatis. Stratified analysis and logistic regression analyses were employed. Results: Odds ratio for tubal occlusion associated with previous use of a copper IUD was 1.0 (95% CI, 0.6–1.7) using infertile controls. When the primigravid women served as controls, the odds ratio was 0.9 (95% CI, 0.5–1.6). Odds ratio for tubal occlusion associated with chlamydia was 2.4 (95% CI, 1.7–3.2). Conclusions: Previous use of a copper IUD is not associated with increased risk of tubal occlusion among nulligravid women; rather, chlamydial infection is. These results have been confirmed by others: Hov GG, Skjeldestad FE, Hilstad T. Use of IUD and subsequent fertility: Follow-up after participation in a randomized clinical trial. Contraception. 2007;75:88-92. Skjeldestad F, Bratt H. Fertility after complicated and non-complicated use of IUDs. A controlled prospective study. Adv Contracept. 1988;4:179-84. Wilson JC. A prospective New Zealand study of fertility after removal of copper intrauterine contraceptive devices for conception and because of complications: A four-year study. Am J Obstet Gynecol. 1989;160:391-6.

Presentation Notes: Research indicates that return of fertility after IUD removal is rapid, similar to that after discontinuation of barrier methods.

Presentation Notes: A 1999 study in Kenya found that copper IUD insertion did not significantly change the shedding of HIV-infected cervical cells. WHO gives both the copper T and the levonorgestrel IUD a Category 2 medical eligibility rating, suggesting that the benefit of women with HIV infection using an effective contraceptive method outweighs potential risk of infection. Category 1: A condition for which there is no restriction for the use of the contraceptive method. Category 2: A condition where the advantages of using the method generally outweigh the theoretical or proven risks. Category 3: A condition in which the theoretical or proven risks usually outweigh the advantages of the method. Category 4: A condition which represents unacceptable health risk if the method is used (i.e. contraindications).

Presentation Notes: Many women have concerns about the use of hormones and the risk of breast cancer. A 2005 Finnish postmarketing study of users of levonorgestrel-releasing IUDs (n=17,360) offers reassurance that use of this IUD is not associated with an increased risk of breast cancer.

Presentation Notes: The data are also reassuring that IUD use does not increase the risk of infertility in nulliparous women. The risk of PID and subsequent infertility is dependent on non-IUD factors ( e.g. a woman’s exposure to STIs).

Presentation Notes: A 1-year randomized Finnish study compared the safety and acceptability of the LNG IUD (n=94) and oral contraceptives (OCs) (n=99) in young, nulliparous women. Nineteen women (20%) in the LNG IUD group discontinued the study, as did 27 (27%) of the OC group. The most common reason for discontinuation (31%) in the IUD group was pain. The most common reason for discontinuation in the OC group was hormonal side effects. Conclusion: The safety and acceptability of the LNG IUD for contraception in nulliparous women are as good as with OCs with a high continuation rate.

Presentation Notes: Before a labeling change in 2005, ParaGard’s product information stated that the device was recommended for women “who have had at least one child, are in a stable, mutually monogamous relationship, and have no history of pelvic infection.”, Current labeling does not exclude nulliparous women or those who are not in a mutually monogamous relationship. Mirena labeling’s recommended patient profile is a woman who has had at least one child, is in a stable, mutually monogamous relationship, and has no history of pelvic infection. Clinicians sometimes choose nulliparous candidates for use of either IUD.

Presentation Notes: The copper T IUD may result in heavier or prolonged menses. During the first 3 to 6 months of LNG IUD use, bleeding may be irregular and the number of days with bleeding or spotting may be increased from baseline. Thereafter, bleeding generally decreases to the point that about 50% of users have amenorrhea at 12 months after insertion. In fact, the LNG IUD has been investigated for treatment of menorrhagia. One clinical trial found that the LNG IUD was as effective as endometrial ablation at reducing blood loss when assessed 1 year after insertion.