Echo Therapeutics Licenses Needle-Free Prelude SkinPrep System to Ferndale Pharma for Enhanced Delivery of Topical Lidocaine FRANKLIN, Mass., May 28 /CNW/ -- Echo Therapeutics, Inc. (OTC Bulletin Board: ECTE) announced today that it has signed a license agreement with Ferndale Pharma Group ("Ferndale"), under which Echo granted Ferndale the right to develop, market, sell and distr
Suomen sivusto, jossa voit ostaa halvalla ja laadukas Viagra http://osta-apteekki.com/ toimitus kaikkialle maailmaan.
Erityisesti laatu viagra tästä kaupasta voi taata henkilökohtaisesti priligy Paras laatu kehotan Teitä miellyttää.
Johnson.pdfInsertion and Removal
of Intrauterine Devices
BRETT ANDREW JOHNSON, M.D., Methodist Charlton Medical Center, Dallas, Texas
The intrauterine device (IUD) is an effective contraceptive for many women. The copper-releas-
ing IUD can be used for 10 years before replacement and is a good choice for women who cannot,
or choose not to, use hormone-releasing contraceptives. However, some women experience an
increase in menstrual blood loss and dysmenorrhea. The progestin-releasing IUD can be used for
five years. It may reduce menorrhagia and dysmenorrhea, although some women have increased
spotting and bleeding during the first months after insertion. The ideal candidates for IUD use are
parous women in stable, monogamous relationships. Pregnancy, unexplained vaginal bleeding,
and a lifestyle placing the woman at risk for sexually transmitted diseases are contraindications to
IUD use. Insertion of the IUD can take place at any time during the menstrual cycle provided the
woman is not pregnant. Before insertion, a bimanual examination and a sounding of the uterus
are necessary to determine the uterus position and the depth of the uterine cavity. The IUD is
inserted into the uterus according to individual protocols, with the threads cut at a length to allow
the patient to check the device’s position. Expulsion may occur with both types of IUDs. (Am Fam
Physician 2005;71:95-102. Copyright 2005 American Academy of Family Physicians.)
the United States: a copper-releasing device ceptive choice for women. In 1995, (ParaGard) and a hormone-releasing device the IUD was used by 11.9 percent (Mirena). Both IUDs have monofilament of women of reproductive age worldwide, threads that minimize the risk for bacteria but by only 1.5 percent of women in North transmission. America.1 A potential reason for this dif- The copper-releasing IUD (Figure 1) is ference in use is the negative perception of a T-shaped polyethylene device with 380 IUDs created as a result of complications mm2 of exposed surface area of copper on associated with the Dalkon Shield. its arms and stem. The released copper ions interfere with sperm mobility and incite a duced in 1970 and recalled in 1975. It was foreign-body reaction that results in a sper-associated with a significant incidence of micidal environment.2 Barium sulfate has pelvic inflammatory disease (PID) because been added to the polyethylene substrate its multifilament threads were believed to to make the device radiopaque. A 3-mm be prone to transmitting bacteria into the plastic ball is located at the base of the IUD, uterus and fallopian tubes.
through which the monofilament thread passes. Once inserted, the IUD can remain in place for up to 10 years. The hormone-releasing IUD (Figure 2) is a radiopaque T-shaped device with 52 mg of levonorgestrel on its arms and stem. The progestin is released at a rate of 20 mcg a day. Levonorgestrel is thought to thicken cervical mucus, creating a barrier to sperm penetration through the cervix, and it may stop ovulation and thin the uterus lining. Figure 1. Copper-releasing intrauterine device (ParaGard) and inserter.
Once inserted, the IUD can remain in place Reprinted with permission from FEI Women’s Health. January 1, 2005 ◆ Volume 71, Number 1 American Family Physician 95
An ideal candidate for an
IUD is a parous woman in
a stable, mutually monoga-
mous relationship, with no
history of pelvic inflamma-
of action play a role in both IUDs.3 [Evidence level B, sys- copper-releasing IUD and the hormone-releasing IUD have been shown in clinical trials to be 99.2 percent and 98 percent effec- tive, respectively, in preventing pregnancy in The contraceptive effects of the IUD are reversible after removal. The results of a recent study suggest that long-term IUD use (i.e., more than 78 months [6.5 years]) may be associated with an increased risk for fertility impairment.6 [Evidence level C, prospective cohort study] Recommended Patient Profile
IUDs are for parous women who are in
a stable, mutually monogamous relation-
Figure 2. Hormone-releasing intrauterine
ship, with no history of PID. Although not contraindicated in this group, nulliparous Reprinted with permission from Berlex, Inc.
women tend to have higher expulsion and failure rates, and also offer more challenging IUD. A World Health Organization scien-insertion because they have a smaller uterine tific working group concluded that women cavity.7 who have been pregnant after an occurrence Women exposed to sexually transmitted of PID and are not currently at risk for infec- diseases (STDs) have a greater chance of tion can be candidates for IUDs.1developing PID. A history of PID suggests a risk for reinfection, although a remote his- tory does not totally preclude choosing an menorrhea.8 While there is a greater risk for spotting or irregular bleeding during the first three months after insertion of this device, the risk decreases significantly at 12 The Author
BRETT ANDREW JOHNSON, M.D., is program director of the Methodist Health Both IUDs are classified as pregnancy cat- System of Dal as Family Practice Residency at Methodist Charlton Medical egory X. Contraindications are summarized Center, Dal as. He also is an associate professor of family and community medi- cine at the University of Texas Southwestern Medical School, Dal as. He received his medical degree from the State University of New York School of Medicine, Buffalo, and completed a residency in family medicine at Hamot Family Practice Precautions
IUDs may be inserted anytime during the menstrual cycle. Documentation of a nega- Address correspondence to Brett A. Johnson, M.D., Methodist Charlton Medical Center, 3500 W. Wheatland Rd., Dal as, TX 75237. Reprints are not available tive pregnancy test is prudent. Insertion may 96 American Family Physician
Volume 71, Number 1 ◆ January 1, 2005 IUD Insertion
provides little, if any, benefit. Doxycycline (Vibramycin) or erythromycin may be used Contraindications to IUD Insertion
ciation, antibiotic prophylaxis in patients at risk for endocarditis is not necessary before IUD insertion or removal.14 [Evidence level Genital actinomycosisHistory of ectopic pregnancy Patient Preparation
History of pelvic inflammatory disease unless The physician should discuss with the patient subsequent intrauterine pregnancy occurred the risks and benefits of the IUD and, if necessary, other forms of contraception. The patient should review the manufactur- er’s patient information materials and have the opportunity to discuss with her physi- Multiple sexual partners for patient or her Postpartum endometritis or septic abortion in The position and depth
of the uterus should be
determined before insert-
ing the IUD.
insertion may alleviate discomfort. The phy- *—Specific for hormone-releasing IUD (Mirena). sician should instruct the patient about how †—Specific for copper-releasing IUD (ParaGard). to locate the IUD threads. It is necessary for Information from references 4, 5, 7, 10, and 11. the woman to locate the threads to verify the position of the IUD after each menstruation. The patient should be told to call her physi- vide additional reassurance that the woman cian’s office if she is ever unable to locate the is not pregnant. If insertion is planned during the luteal phase, another nonhormonal contraceptive Insertion
should be used until after the next menses. A COPPER-RELEASING IUD
pregnancy test can be done, but the patient The proper equipment (Table 2) should
should be made aware that a pregnancy test be assembled before the procedure. Then,
at this time cannot always rule out early a bimanual examination with nonsterile
gloves should be performed to determine the An IUD should not be inserted in a position of the uterus. The arms of the IUD are to be folded into lege of Obstetricians and Gynecologists the insertion tube far enough to retain them. recommends a pelvic examination before This can be done before the start of the pro-insertion to screen for Chlamydia and cedure, working through the sterile package gonorrhea.12 [Evidence level C, consensus/ Sterile technique, including sterile gloves, is necessary during the procedure to mini- istration is not necessary.13 [Evidence level mize the risk of contamination or infection. A, high-quality meta-analysis] Studies have The cervix and adjacent vaginal fornices demonstrated that the use of prophylactic should be cleansed liberally with an anti-antibiotics at the time of IUD insertion septic solution. Chlorhexidine gluconate January 1, 2005 ◆ Volume 71, Number 1 American Family Physician 97
Equipment for IUD Insertion
Cervical tenaculum Cotton bal s moistened with antiseptic solution or povidone-iodine (Betadine) swabs Long suture scissors Ring forceps Sterile and nonsterile examination gloves Sterile IUD package with IUD Sterile tray for the procedure Sterile vaginal speculum Figure 3. The arms of the copper-releasing
intrauterine device are folded into the inser- Reprinted with permission from FEI Women’s Health. (Hibiclens) may be used if the patient is be pulled back on the insertion rod approxi-allergic to iodine.
mately 2 cm so that the arms can spread to the “T” position (Figure 4). The tube should vix during the insertion of the IUD with a be advanced slowly to ensure a correct posi-tenaculum. Local anesthesia, such as 5 per- tioning of the IUD (Figure 5). The physi- cent lidocaine gel (Xylocaine) placed in the cian should remove the insertion rod by cervical canal, or a paracervical block may holding the insertion tube in place (Figure be used to minimize discomfort. 6) and then remove the insertion tube and A sterile uterine sound should be used to the tenaculum. Finally, the threads emerg- determine the depth of the uterine cavity. ing from the cervical os should be cut to a
Contact with the vagina or speculum blades length of 3 cm. The length of the threads in
should be avoided. The uterine sound has the vagina should be noted in the patient’s
a bulbous tip to help prevent perforation. record for further reference.
An alternative to the uterine sound is an
endometrial aspirator such as those used HORMONE-RELEASING IUD
for endometrial biopsy sampling. An ade-
As with the copper-releasing IUD, the proper quate uterine depth is between 6 and 9 cm equipment (Table 2) for insertion of the hor-and should be documented in the patient’s mone-releasing IUD should be assembled record. An IUD should not be inserted if the before the procedure. Then, a bimanual depth of the uterus is less than 6 cm.
examination with nonsterile gloves should be The physician should use sterile gloves to done to determine the position of the uterus. remove the IUD from the sterile package. Sterile technique with sterile gloves is neces-The blue flange should be aligned with the sary during the procedure itself to minimize IUD arms and set at the distance the uterus the risk of contamination or infection. The was sounded. The white inserter rod should cervix and adjacent vaginal mucosa should then be placed into the insertion tube at be cleansed liberally with an antiseptic solu-the end opposite the arms of the IUD and tion. Chlorhexidine gluconate may be used approximated against the ball at the base of if the patient is allergic to iodine. the IUD. The physician should then insert the IUD vix during the insertion of the IUD with into the uterus until the flange is against the a tenaculum. Local anesthesia, such as cervical os. The clear inserter tube should 5 percent lidocaine gel placed in the cervical 98 American Family Physician
Volume 71, Number 1 ◆ January 1, 2005 IUD Insertion
Figure 4. The arms of the copper-releasing
intrauterine device are released.
Reprinted with permission from FEI Women’s Health. Figure 7. The arms of the hormone-releasing
intrauterine device are aligned to a horizontal position when removing the device from the package.
Reprinted with permission from Berlex, Inc. Figure 5. The insertion tube is advanced for
placement of the copper-releasing intrauter- mented in the patient’s record. An IUD Reprinted with permission from FEI Women’s Health. should not be inserted if the depth of the uterus is less than 6 cm.
IUD package, put on sterile gloves, pick up the inserter containing the IUD, and care-fully release the threads from behind the slider, allowing them to hang freely. The slider should be positioned at the top of the handle nearest the IUD. While looking at the insertion tube, the physician should check that the arms of the device are hori-zontal. If not, they must be aligned using Figure 6. The insertion rod of the copper-
sterile technique (Figure 7). The physician releasing intrauterine device is withdrawn.
Reprinted with permission from FEI Women’s Health. IUD into the insertion tube so that the knobs at the end of the arms cover the open canal, or a paracervical block may be used to end of the inserter (Figure 8). The threads minimize discomfort. should be fixed tightly in the cleft at the end of the handle (Figure 9), and the flange trial aspirator should be used to determine should be set to the depth measured by the the depth of the uterine cavity. Contact sound (Figure 10).
with the vagina or speculum blades should be avoided. An adequate uterine depth is by holding the slider firmly at the top of between 6 and 9 cm and should be docu- the handle and gently placing the inserter January 1, 2005 ◆ Volume 71, Number 1 American Family Physician 99
Figure 10. The flange is adjusted to sound
Figure 8. The hormone-releasing intrauterine Reprinted with permission from Berlex, Inc.
device is drawn into the insertion tube.
Reprinted with permission from Berlex, Inc. line on the handle (Figure 11). The inserter should be pushed gently into the uterine cavity until the flange touches the cervix. the top of the fundus. The physician then releases the IUD by pulling the slider all the way down while holding the inserter firmly in position. The threads will be released auto-matically (Figure 12). The inserter should be removed from the uterus. Finally, the threads emerging from the cervical os should be cut to a length of 2 to 3 cm. The length of the threads in the vagina should be noted in the patient’s record for further reference. created practice kits that can help physicians learn to insert an IUD. Figure 9. Threads are fixed tightly in the cleft.
Reprinted with permission from Berlex, Inc. Following insertion of either device, a fol- low-up appointment should be planned after into the cervical canal. The insertion tube the next menses to address any concerns or should be advanced into the uterus until adverse effects, ensure the absence of infec-the flange is situated at a distance of about tion, and check the presence of the strings. 1.5 to 2 cm from the external cervical os, allowing ample space for the IUD arms to are cramping, abnormal uterine bleeding, open. While holding the inserter steady, and expulsion (Table 3).4,5,7,11,12 Adverse the physician should release the arms of the effects related specifically to the hormone-IUD by pulling the slider back until the top releasing IUD include amenorrhea, acne, of the slider reaches the raised horizontal depression, weight gain, decreased libido, 100 American Family Physician
Volume 71, Number 1 ◆ January 1, 2005 IUD Insertion
perforation, which is more likely to occur during insertion of the device, ranges from 0.1 to 0.3 percent.11 When the results of the pregnancy test are positive, an ectopic implantation must be ruled out. If the strings are visible and the pregnancy is early, the IUD can be removed but with a risk of pregnancy loss. If the strings are not visible, ultrasonography should be performed to identify the IUD for removal.
ration date, when the patient develops a Figure 11. The slider is pulled back to reach contraindication, when adverse effects do
not resolve, or on patient request. Treat- Reprinted with permission from Berlex, Inc. ment for cervical dysplasia may be different with the IUD present. Colposcopy may be performed, but the IUD should be removed if an excisional procedure is performed. ing the threads at the external os with ring forceps. Traction should be applied away from the cervix. If resistance is met, the removal should be abandoned until it is determined why the IUD is not moving. A deeply embedded IUD may have to be TABLE 3
Adverse Effects or Complications
Figure 12. The inserter is withdrawn while the
Reprinted with permission from Berlex, Inc. and headache. First-year failure rates are reported to be between 1 and 2 percent.1 If the IUD threads are ever not present, a pregnancy test should be performed. When the results are negative, a cytobrush can be inserted gently into the cervical canal to locate the threads. If this method is unsuc- Information from references 4, 5, 7, 11, and 12. January 1, 2005 ◆ Volume 71, Number 1 American Family Physician 101
The author thanks Kaydance Kerrick for assistance with 7. Nelson AL. The intrauterine contraceptive device. Obstet Gynecol Clin North Am 2000;27:723-40.
8. Ronnerdag M, Odlind V. Health effects of long-term The author indicates that he does not have any conflicts use of the intrauterine levonorgestrel-releasing system. of interest. Sources of funding: none reported.
A fol ow-up study over 12 years of continuous use. Acta Obstet Gynecol Scand 1999;78:716-21. 9. Andersson K, Odlind V, Rybo G. Levonorgestrel-releas- REFERENCES
ing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Contra- 1. IUDs—an update. Popul Rep B 1995;(6):1-35.
2. Spinatto JA 2d. Mechanism of action of intrauterine 10. Physicians’ Desk Reference. 58th ed. Montvale, N.J.: contraceptive devices and its relation to informed con- sent. Am J Obstet Gynecol 1997;176:503-6. 11. Canavan TP. Appropriate use of the intrauterine device. 3. Stanford JB, Mikolajczyk RT. Mechanisms of action of Am Fam Physician 1998;58:2077-84,2087-8.
intrauterine devices: update and estimation of postfer- 12. American Col ege of Obstetricians and Gynecologists. tilization effects. Am J Obstet Gynecol 2002;187:1699- The intrauterine device. ACOG technical bul etin no. 4. Mirena [package insert]. Montvil e, N.J.: Berlex Labora- 13. Grimes DA, Schulz KF. Antibiotic prophylaxis for intra- uterine contraceptive device insertion. Cochrane Data- 5. ParaGard [package insert]. Tonawanda, N.Y.: FEI Prod- base Syst Rev 2001;(1):CD001327. Update in: Cochrane Database Syst Rev 2001;(2):CD001327.
6. Doll H, Vessey M, Painter R. Return of fertility in nul ipa- 14. Dajani AS, Taubert KA, Wilson W, Bolger AF, Bayer A, rous women after discontinuation of the intrauterine Ferrieri P, et al. Prevention of bacterial endocarditis. device: comparison with women discontinuing other Recommendations by the American Heart Association. methods of contraception. BJOG 2001;108:304-14.
102 American Family Physician
Volume 71, Number 1 ◆ January 1, 2005
The new Orgalime S 2012 conditions: an overview of the major changes 1. Revision of the Orgalime S 2000 Conditions As the international sale of products represents the core business of companies in the mechanical and electrical engineering industries in Europe, Orgalime has soon recognised that these com- panies would benefit from a set of general conditions for the supply of pro