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The diaphragm is a barrier method of
birth control Birth control, also known as contraception, anticonception, and fertility control, is the use of methods or devices to prevent unwanted pregnancy. Birth control has been used since ancient times, but effective and safe methods of birth contr ...
. It is moderately effective, with a one-year failure rate of around 12% with typical use. It is placed over the
cervix The cervix or cervix uteri (Latin, 'neck of the uterus') is the lower part of the uterus (womb) in the human female reproductive system. The cervix is usually 2 to 3 cm long (~1 inch) and roughly cylindrical in shape, which changes during ...
with spermicide before sex and left in place for at least six hours after sex. Fitting by a healthcare provider is generally required. Side effects are usually very few. Use may increase the risk of
bacterial vaginosis Bacterial vaginosis (BV) is a disease of the vagina caused by excessive growth of bacteria. Common symptoms include increased vaginal discharge that often smells like fish. The discharge is usually white or gray in color. Burning with urinati ...
and urinary tract infections. If left in the
vagina In mammals, the vagina is the elastic, muscular part of the female genital tract. In humans, it extends from the vestibule to the cervix. The outer vaginal opening is normally partly covered by a thin layer of mucosal tissue called the hymen ...
for more than 24 hours toxic shock syndrome may occur. While use may decrease the risk of sexually transmitted infections, it is not very effective at doing so. There are a number of types of diaphragms with different rim and spring designs. They may be made from
latex Latex is an emulsion (stable dispersion) of polymer microparticles in water. Latexes are found in nature, but synthetic latexes are common as well. In nature, latex is found as a milky fluid found in 10% of all flowering plants (angiosperms ...
,
silicone A silicone or polysiloxane is a polymer made up of siloxane (−R2Si−O−SiR2−, where R = organic group). They are typically colorless oils or rubber-like substances. Silicones are used in sealants, adhesives, lubricants, medicine, cookin ...
, or natural rubber. They work by blocking access to and holding spermicide near the cervix. The diaphragm came into use around 1882. It is on the World Health Organization's List of Essential Medicines.


Medical use

Before inserting or removing a diaphragm, one's hands should be washed to avoid introducing harmful bacteria into the vaginal canal. The rim of a diaphragm is squeezed into an oval or arc shape for insertion. A water-based lubricant (usually spermicide) may be applied to the rim of the diaphragm to aid insertion. One teaspoon (5 mL) of spermicide may be placed in the dome of the diaphragm before insertion, or with an applicator after insertion. The diaphragm must be inserted sometime before
sexual intercourse Sexual intercourse (or coitus or copulation) is a sexual activity typically involving the insertion and thrusting of the penis into the vagina for sexual pleasure or reproduction.Sexual intercourse most commonly means penile–vaginal pene ...
, and remain in the vagina for 6 to 8 hours after a man's last ejaculation. For multiple acts of intercourse, it is recommended that an additional 5 mL of spermicide be inserted into the vagina (not into the dome—the seal of the diaphragm should not be broken) before each act. Upon removal, a diaphragm should be cleansed with mild soap and warm water before storage. The diaphragm must be removed for cleaning at least once every 24 hours and can be re-inserted immediately. Oil-based products should not be used with latex diaphragms. Lubricants or vaginal medications that contain oil will cause the latex to rapidly degrade and greatly increases the chances of the diaphragm breaking or tearing. Natural latex rubber will degrade over time. Depending on usage and storage conditions, a latex diaphragm should be replaced every one to three years. Silicone diaphragms may last much longer—up to ten years.


Effectiveness

The effectiveness of diaphragms, as of most forms of
contraception Birth control, also known as contraception, anticonception, and fertility control, is the use of methods or devices to prevent unwanted pregnancy. Birth control has been used since ancient times, but effective and safe methods of birth contr ...
, can be assessed two ways: ''method effectiveness'' and ''actual effectiveness''. The method effectiveness is the proportion of couples correctly and consistently using the method who do not become pregnant. Actual effectiveness is the proportion of couples who intended that method as their sole form of birth control and do not become pregnant; it includes couples who sometimes use the method incorrectly, or sometimes not at all. Rates are generally presented for the first year of use. Most commonly the Pearl Index is used to calculate effectiveness rates, but some studies use decrement tables. For all forms of contraception, actual effectiveness is lower than method effectiveness, due to several factors: * mistakes on the part of those providing instructions on how to use the method * mistakes on the part of the method's users * conscious user non-compliance with method For instance, someone using a diaphragm might be fitted incorrectly by a health care provider, or by mistake remove the diaphragm too soon after intercourse, or simply choose to have intercourse without placing the diaphragm. ''Contraceptive Technology'' reports that the method failure rate of the diaphragm with spermicide is 6% per year. The actual pregnancy rates among diaphragm users vary depending on the population being studied, with yearly rates of 10% to 39% being reported. Unlike some other cervical barriers, the effectiveness of the diaphragm is the same for women who have given birth as for those who have not.


Advantages

The diaphragm does not interfere with a woman's menstrual cycle, therefore, no reversal or wait time is necessary if contraception is no longer wanted or needed. The diaphragm only has to be used during intercourse. Many women, especially those who have sex less frequently, prefer
barrier contraception Birth control, also known as contraception, anticonception, and fertility control, is the use of methods or devices to prevent unwanted pregnancy. Birth control has been used since ancient times, but effective and safe methods of birth cont ...
such as the diaphragm over methods that require some action every day. Like all cervical barriers, diaphragms may be inserted several hours before use, allowing uninterrupted foreplay and intercourse. Most couples find that neither partner can feel the diaphragm during intercourse. The diaphragm is less expensive than many other methods of contraception.


Sexually transmitted infections

There is some evidence that the cells in the cervix are particularly susceptible to certain sexually transmitted infections (STIs). Cervical barriers such as diaphragms may offer some protection against these infections. However, research conducted to test whether the diaphragm offers protection from HIV found that women provided with both male condoms and a diaphragm experienced the same rate of HIV infection as women provided with male condoms alone. Because
pelvic inflammatory disease Pelvic inflammatory disease, also known as pelvic inflammatory disorder (PID), is an infection of the upper part of the female reproductive system, namely the uterus, fallopian tubes, and ovaries, and inside of the pelvis. Often, there may be ...
(PID) is caused by certain STIs, diaphragms may lower the risk of PID. Cervical barriers may also protect against
human papillomavirus Human papillomavirus infection (HPV infection) is caused by a DNA virus from the '' Papillomaviridae'' family. Many HPV infections cause no symptoms and 90% resolve spontaneously within two years. In some cases, an HPV infection persists and r ...
(HPV), the virus that causes
cervical cancer Cervical cancer is a cancer arising from the cervix. It is due to the abnormal growth of cells that have the ability to invade or spread to other parts of the body. Early on, typically no symptoms are seen. Later symptoms may include abnormal ...
, although the protection appears to be due to the spermicide used with diaphragms and not the barrier itself. Diaphragms are also considered a good candidate as a delivery method for
microbicide An antimicrobial is an agent that kills microorganisms or stops their growth. Antimicrobial medicines can be grouped according to the microorganisms they act primarily against. For example, antibiotics are used against bacteria, and antifungals ...
s (preparations that, used vaginally, protect against STIs) that are currently in development.


Side effects

Women (or their partners) who are allergic to
latex Latex is an emulsion (stable dispersion) of polymer microparticles in water. Latexes are found in nature, but synthetic latexes are common as well. In nature, latex is found as a milky fluid found in 10% of all flowering plants (angiosperms ...
should not use a latex diaphragm. Diaphragms are associated with an increased risk of
urinary tract infection A urinary tract infection (UTI) is an infection that affects part of the urinary tract. When it affects the lower urinary tract it is known as a bladder infection (cystitis) and when it affects the upper urinary tract it is known as a kidne ...
(UTI) Urinating before inserting the diaphragm, and also after intercourse, may reduce this risk. Toxic shock syndrome (TSS) occurs at a rate of 2.4 cases per 100,000 women using diaphragms, almost exclusively when the device is left in place longer than 24 hours. The increase in risk of UTIs may be due to the diaphragm applying pressure to the
urethra The urethra (from Greek οὐρήθρα – ''ourḗthrā'') is a tube that connects the urinary bladder to the urinary meatus for the removal of urine from the body of both females and males. In human females and other primates, the urethra ...
, especially if the diaphragm is too large, and causing irritation and preventing the bladder from emptying fully. However, the spermicide nonoxynol-9 is itself associated with increased risk of UTI, yeast infection, and
bacterial vaginosis Bacterial vaginosis (BV) is a disease of the vagina caused by excessive growth of bacteria. Common symptoms include increased vaginal discharge that often smells like fish. The discharge is usually white or gray in color. Burning with urinati ...
. For this reason, some advocate use of lactic acid or lemon juice based spermicides, which might have fewer side effects. It has also been suggested that, for women who experience side effects from nonoxynol-9, it may be acceptable to use the diaphragm without any spermicide. One study found an actual pregnancy rate of 24% per year in women using the diaphragm without spermicide; however, all women in this study were given a 60 mm diaphragm rather than being fitted by a clinician. Other studies have been small and given conflicting results. The current recommendation is still for all diaphragm users to use spermicide with the device. In the early 1920s,
Marie Stopes Marie Charlotte Carmichael Stopes (15 October 1880 – 2 October 1958) was a British author, palaeobotanist and campaigner for eugenics and women's rights. She made significant contributions to plant palaeontology and coal classificati ...
claimed that when wearing a diaphragm, the vagina is stretched such that certain movements made by the woman for the benefit of the man were restricted by the diaphragm spring. In later years there was some discussion of this, with two authors supporting this concept and one opposed. One of them argued in the later 1920s-1930s that while the muscle movement by women is restricted it does not make all that much difference since most "women (in the 1920s) are not able to operate their pelvic muscles voluntarily to the best advantage" (during sex). However, Stopes anticipated this rebuttal, and in so many words classified it as a lame excuse.


Types

Diaphragms are available in diameters of 50 mm to 105mm (about 2–4 inches). They are available in two different materials:
latex Latex is an emulsion (stable dispersion) of polymer microparticles in water. Latexes are found in nature, but synthetic latexes are common as well. In nature, latex is found as a milky fluid found in 10% of all flowering plants (angiosperms ...
and
silicone A silicone or polysiloxane is a polymer made up of siloxane (−R2Si−O−SiR2−, where R = organic group). They are typically colorless oils or rubber-like substances. Silicones are used in sealants, adhesives, lubricants, medicine, cookin ...
. Diaphragms are also available with different types of springs in the rim. An ''arcing spring'' folds into an arc shape when the sides are compressed. This is the strongest type of rim available in a diaphragm, and may be used by women with any level of vaginal tone. Unlike other spring types, arcing springs may be used by women with mild
cystocele A cystocele, also known as a prolapsed bladder, is a medical condition in which a woman's bladder bulges into her vagina. Some may have no symptoms. Others may have trouble starting urination, urinary incontinence, or frequent urination. Complicat ...
, rectocele, or retroversion. Arcing spring diaphragms may be easier to insert correctly than other spring types. A ''coil spring'' flattens into an oval shape when the sides are compressed. This rim is not as strong as the arcing spring, and may only be used by women with average or firm vaginal tone. If an arcing spring diaphragm is uncomfortable for a woman or, during intercourse, her partner, a coil spring may prove more satisfactory. Unlike the arcing spring diaphragms, coil springs may be inserted with a device called an introducer. A ''flat spring'' is much like a coil spring, but thinner. This type of rim may only be used by women with firm vaginal tone. Flat spring diaphragms may also be inserted with an introducer for women uncomfortable using their hands. Ortho used to manufacture a flat-spring diaphragm called the Ortho White. Reflexions also manufactured a flat-spring diaphragm up until 2014. There are a number of variations. The SILCS diaphragm is made of silicone, has an arcing spring, and a finger cup is molded on one end for easy removal. The Duet disposable diaphragm is made of dipped polyurethane, pre-filled with BufferGel (BufferGel is currently in clinical trials as a spermicide and
microbicide An antimicrobial is an agent that kills microorganisms or stops their growth. Antimicrobial medicines can be grouped according to the microorganisms they act primarily against. For example, antibiotics are used against bacteria, and antifungals ...
). Both the SILCS and Duet diaphragms come in only one size.


Fitting

Diaphragms usually come in different sizes and require a fitting appointment with a health care professional to determine which size a woman should wear. Single size diaphragms that do not require fitting also exist. A correctly fitting diaphragm will cover the
cervix The cervix or cervix uteri (Latin, 'neck of the uterus') is the lower part of the uterus (womb) in the human female reproductive system. The cervix is usually 2 to 3 cm long (~1 inch) and roughly cylindrical in shape, which changes during ...
and rest snugly against the pubic bone. A diaphragm that is too small might fit inside the vagina without covering the cervix, or might become dislodged from the cervix during intercourse or bowel movements. It is also more likely that a woman's partner will feel the anterior rim of a diaphragm that is too small during intercourse. A diaphragm that is too large will place pressure on the
urethra The urethra (from Greek οὐρήθρα – ''ourḗthrā'') is a tube that connects the urinary bladder to the urinary meatus for the removal of urine from the body of both females and males. In human females and other primates, the urethra ...
, preventing the bladder from emptying completely and increasing the risk of
urinary tract infection A urinary tract infection (UTI) is an infection that affects part of the urinary tract. When it affects the lower urinary tract it is known as a bladder infection (cystitis) and when it affects the upper urinary tract it is known as a kidne ...
. A diaphragm that is too large may also cause a sore to develop on the vaginal wall. Diaphragms should be re-fitted after a weight change of 4.5 kg (10 lb) or more. The traditional clinical guideline is that a decrease in weight may cause a woman to need a larger size, although the strength of this relationship has been questioned. Diaphragms should also be re-fitted after any pregnancy of 14 weeks or longer. Full-term vaginal delivery especially will tend to increase the size diaphragm a woman needs, although the changes to the pelvic floor during pregnancy mean even women who experience second-trimester miscarriage, or deliver by C-section, should be refitted. ''Vaginal tenting'', an increase in the length of the vagina, occurs during arousal. This means that during intercourse, the diaphragm will not fit snugly against the pubic bone because it is carried higher up the vaginal canal by the movement of the cervix. If the diaphragm is inserted after arousal has begun, extra care must be taken to ensure the device is covering the cervix. A woman might be fitted with a different size diaphragm depending on where she is in her
menstrual cycle The menstrual cycle is a series of natural changes in hormone production and the structures of the uterus and ovaries of the female reproductive system that make pregnancy possible. The ovarian cycle controls the production and release of eggs ...
. It is common for a woman to wear a larger diaphragm during menstruation. It has been speculated that a woman may be fitted with a larger size diaphragm when she is near ovulation. The correct size for a woman is the largest size that she can wear comfortably throughout her cycle. In the United States, diaphragms are available by prescription only. Many other countries do not require prescriptions.


Mechanism of action

The spring in the rim of the diaphragm forms a seal against the vaginal walls. The diaphragm covers the
cervix The cervix or cervix uteri (Latin, 'neck of the uterus') is the lower part of the uterus (womb) in the human female reproductive system. The cervix is usually 2 to 3 cm long (~1 inch) and roughly cylindrical in shape, which changes during ...
, and physically prevents sperm from entering the
uterus The uterus (from Latin ''uterus'', plural ''uteri'') or womb () is the organ in the reproductive system of most female mammals, including humans that accommodates the embryonic and fetal development of one or more embryos until birth. The ...
through the os. Traditionally, the diaphragm has been used with spermicide, and it is widely believed the spermicide significantly increases the effectiveness of the diaphragm. Insufficient studies have been conducted to determine effectiveness without spermicide. It is widely taught that additional spermicide must be placed in the vagina if intercourse occurs more than six hours after insertion. However, there has been very little research on how long spermicide remains active within the diaphragm. One study found that spermicidal jelly and creme used in a diaphragm retained its full spermicidal activity for twelve hours after placement of the diaphragm. It has long been recommended that the diaphragm be left in place for at least six or eight hours after intercourse. No studies have been done to determine the validity of this recommendation, however, and some medical professionals have suggested intervals of four hours or even two hours are sufficient to ensure efficacy. One manufacturer of contraceptive sponges recommends leaving the sponge in place for only two hours after intercourse. However, such use of the diaphragm (removal before 6 hours post-intercourse) has never been formally studied, and cannot be recommended. It has been suggested that diaphragms be dispensed as a one-size-fits-all device, providing all women with the most common size (70 mm). However, only 33% of women fitted for a diaphragm are prescribed a 70 mm size, and correct sizing of the diaphragm is widely considered necessary.


History

The idea of blocking the cervix to prevent pregnancy is thousands of years old. Various cultures have used cervix-shaped devices such as oiled paper cones or lemon halves, or have made sticky mixtures that include
honey Honey is a sweet and viscous substance made by several bees, the best-known of which are honey bees. Honey is made and stored to nourish bee colonies. Bees produce honey by gathering and then refining the sugary secretions of plants (primar ...
or cedar
resin In polymer chemistry and materials science, resin is a solid or highly viscous substance of plant or synthetic origin that is typically convertible into polymers. Resins are usually mixtures of organic compounds. This article focuses on nat ...
to be applied to the cervical opening. However, the diaphragm—which stays in place because of the spring in its rim, rather than hooking over the cervix or being sticky—is of more recent origin. An important precursor to the invention of the diaphragm was the rubber vulcanization process, patented by Charles Goodyear in 1844. In the 1880s, a
German German(s) may refer to: * Germany (of or related to) **Germania (historical use) * Germans, citizens of Germany, people of German ancestry, or native speakers of the German language ** For citizens of Germany, see also German nationality law **Ge ...
gynecologist, Wilhelm P. J. Mensinga, published the first description of a rubber contraceptive device with a spring molded into the rim. Mensinga wrote first under the pseudonym C. Hasse, and the Mensinga diaphragm was the only brand available for many decades. In the United States, the physician Edward Bliss Foote designed and sold an early form of occlusive pessary under the name " womb veil" starting in the 1860s. American birth control activist
Margaret Sanger Margaret Higgins Sanger (born Margaret Louise Higgins; September 14, 1879September 6, 1966), also known as Margaret Sanger Slee, was an American birth control activist, sex educator, writer, and nurse. Sanger popularized the term "birth contro ...
fled to Europe in 1914 to escape prosecution under the Comstock laws, which prohibited sending contraceptive devices, or information about contraception, through the mail. Sanger learned about the diaphragm in the
Netherlands ) , anthem = ( en, "William of Nassau") , image_map = , map_caption = , subdivision_type = Sovereign state , subdivision_name = Kingdom of the Netherlands , established_title = Before independence , established_date = Spanish Netherl ...
and introduced the product to the
United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country Continental United States, primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., ...
when she returned in 1916. Sanger and her second husband, Noah Slee, illegally imported large quantities of the devices from Germany and the Netherlands. In 1925, Slee provided funding to Sanger's friend Herbert Simonds, who used the funds to found the first diaphragm manufacturing company in the U.S., the Holland-Rantos Company. Diaphragms played a role in overturning the federal Comstock Act. In 1932, Sanger arranged for a Japanese manufacturer to mail a package of diaphragms to a New York physician who supported Sanger's activism. U.S. customs confiscated the package, and Sanger helped file a lawsuit. In 1936, in the court case ''
United States v. One Package of Japanese Pessaries ''United States v. One Package of Japanese Pessaries'', 86 F.2d 737 ( 2d Cir. 1936) (often just ''U.S. v. One Package''), was an ''in rem'' United States Court of Appeals case in the Second Circuit involving birth control. Background In 1873 ...
'', a federal appellate court ruled that the package could be delivered. Although in Europe, the
cervical cap The cervical cap is a form of barrier contraception. A cervical cap fits over the cervix and blocks sperm from entering the uterus through the external orifice of the uterus, called the ''os''. Terminology The term ''cervical cap'' has been ...
was more popular than the diaphragm, the diaphragm became one of the most widely used contraceptives in the United States. In 1940, one-third of all U.S. married couples used a diaphragm for contraception. The number of women using diaphragms dropped dramatically after the 1960s introduction of the
intrauterine device An intrauterine device (IUD), also known as intrauterine contraceptive device (IUCD or ICD) or coil, is a small, often T-shaped birth control device that is inserted into the uterus to prevent pregnancy. IUDs are one form of long-acting revers ...
and the
combined oral contraceptive pill The combined oral contraceptive pill (COCP), often referred to as the birth control pill or colloquially as "the pill", is a type of birth control that is designed to be taken orally by women. The pill contains two important hormones: proges ...
. In 1965, only 10% of U.S. married couples used a diaphragm for contraception. That number has continued to fall, and in 2002 only 0.2% of American women were using a diaphragm as their primary method of contraception. In 2014 Janssen Pharmaceuticals announced the discontinuation of the Ortho-All Flex Diaphragm, making it very difficult for women in the US to have that option as a birth-control method. The single-sized, silicone diaphragm was developed by PATH during the late 2000s. It was licensed to Kessel Marketing & Vertriebs GmbH of Frankfurt, Germany, which began to market it as the Caya Diaphragm. The diaphragm was approved for contraception in Europe in 2013 and in the United States the following year. Since then, Kessel has also developed a traditionally circular, multi-sized diaphragm made from the same materials that they released in Germany in 2020 under the name Singa.


Society and culture


Economics

In the United Kingdom they cost the
National Health Service The National Health Service (NHS) is the umbrella term for the publicly funded healthcare systems of the United Kingdom (UK). Since 1948, they have been funded out of general taxation. There are three systems which are referred to using the " ...
less than £10 each. In the United States they cost about US$15 to $75 and are the birth control method of 0.3% of women. These costs do not include that of spermicide.


References


Further reading

*. {{DEFAULTSORT:Diaphragm (Contraceptive) Barrier contraception Vagina Wikipedia medicine articles ready to translate World Health Organization essential medicines