SOURCES

AthenaInsight. 2017. “The Trump Effect? IUD Visits Rise after Election.” 

https://www.athenahealth.com/insight/trump-effect-iud-visits-rise-after-election

Athenahealth is a health-tech provider that builds tech products for hospitals and care providers that drive financial and clinical results. This piece attempts to explain the recorded spike in clinical visits that were coded as IUD-related after Donald Trump’s election in the U.S. 2016 Presidential Election. The explanation provided in this article highlights the potential legislation that would affect insurance coverage of birth control. The birth control pill can cost up to $600/year, whereas an IUD can cost up to $1,100, but is a one-off cost and can last for an entire presidential administration.

Bayer HealthCare Pharmaceuticals. 2011. “A Guide for Those Considering Birth Control with Mirena.”

https://www.mirena-us.com/assets/Mirena-Brochure_English.pdf

This is a patient-facing brochure produced by Bayer to market Mirena to prospective users. It contains all the required information about contraindications, side effects, and warnings around not protecting against HIV or STIs. It also contains detailed instructions on how to check if Mirena is covered by a specific health plan, as well as information on advocating for coverage from an employer if a health plan doesn’t currently cover Mirena, which is a noteworthy feature of this leaflet. There are also a series of questions that serve as a “conversation starter” that the patient is advised to answer and bring with them on their next visit to their healthcare provider. While this leaflet does contain the requisite warnings, it is still clearly a marketing material and cannot be considered objective.

Bayer HealthCare Pharmaceuticals. 2008. “Mirena.” 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021225s019lbl.pdf

Drugs@FDA is a database where information about every FDA-approved human drug is available for reference to members of the public and other stakeholders. It is updated daily and includes all drugs that have been approved by the FDA since 1939. This source is incredibly technical and clearly aimed toward a more medically-informed audience, with emphasis on the clinical pharmacology, information about clinical studies around Mirena, and data on the effectiveness of the drug and its side effects. In addition to this research, which the FDA uses to evaluate and approve the drug for use, the patient information section allows us to access the information Bayer Pharmaceuticals is choosing to give to patients in leaflet form. This was helpful in understanding what information patients are not getting, even after they have Mirena inserted.

Brannum, Amy and Jo Jones. 2015. “Trends in Long-Acting Reversible Contraception Use Among U.S. Women Aged 15–44.” 188. NCHS Data Brief. Centers for Disease Control and Prevention.

https://www.cdc.gov/nchs/data/databriefs/db188.pdf

This databrief published by the National Center of Health Statistics and its parent organization, the Center for Disease Control explains several trends among Long Acting Reversible Contraception (LARC) use over a period from 1982 to 2013. The findings show that since 2002 the use of LARCs has increased. Additionally, the data confirms that women aged 25–34 who already have a child continue to use LARCs at the highest rates. Another interesting finding that stresses the importance of accurate information is that the research suggests that women choose LARCs when they are informed about these options. Given that the data also demonstrates that LARCs are more effective than other contraceptive methods including the birth control pill at preventing unplanned pregnancies, this databrief reveals just how important it is that women are informed of their contraceptive options.

Havránek, F. 1978. “Which Stage of the Menstrual Cycle in Best Suited for the Insertion of IUD?” Cesk Gynekol.

https://www.ncbi.nlm.nih.gov/pubmed/67930

All the literature around Mirena mentions that the recommended period of time for the Mirena to be inserted is within the first seven days of a woman’s menstrual cycle. This source explains why this is the case. The Mirena should be inserted during a woman’s menstrual cycle as the cervix is dilated, making insertion easier. In addition, by inserting at this time, the woman is more likely to not be pregnant and any bleeding caused by insertion is indistinguishable from menstrual bleeding. This source also mentions that while this is the preference of most clinicians and the recommended stage for insertion, there are situations where insertion at other stages of the menstrual cycle is acceptable.

Kaiser Family Foundation. 2016. “Intrauterine Devices (IUDs): Access for Women in the U.S.” 

https://www.kff.org/womens-health-policy/fact-sheet/intrauterine-devices-iuds-access-for-women-in-the-u-s/

This factsheet reviews factors that affect women’s access to IUDs in the U.S., especially due to the cost of IUDs based on insurance coverage and financing options. Information about how the Affordable Care Act reduced out-of-pocket costs for most women, who prior to the ACA would have had to pay something for either the product or the clinical visit. Under the ACA private insurance companies had to offer at least one hormonal IUD option at no additional cost to patients. At the time of writing, Medicaid coverage of birth control was on a state-by-state basis, and options could be limited to certain types of birth control and/or manufacturers, although women who qualified for Medicaid under the ACA expansion would also have been offered one hormonal IUD option, similar to those who are privately insured. Uninsured women would have to rely on clinics funded under Title X, or funding programs operated by some manufacturers. It is important to note that when cost barriers are removed, research has shown that young women will choose the most highly effective birth control methods like IUDs.

Open Secrets. 2017. “Annual Lobbying by BayerAG.”

https://www.opensecrets.org/lobby/clientsum.php?id=D000042363&year=2017

Opensecrets.org is a project by the nonpartisan Center for Responsive Politics, which aims to track money in the U.S. political system. Given the size of Bayer Pharmaceuticals, along with its parent company Bayer AG, we were curious to understand just how much money Bayer was spending on lobbying and what issue areas they are invested in. According to this source, Bayer AG spent $9,400,000 on lobbying around pharmaceutical and health services in 2017. Bills they registered to lobby on include H.R.1628 American Health Care Act of 2017, H.R.749 Lower Drug Costs through Competition Act, and H.R.909 Pet and Women Safety Act of 2017. This confirms the role of pharmaceutical companies in Congress and influences an important dynamic of our sociotechnical system.

Melo, Juliana et al. 2017. “Women’s willingness and ability to feel the strings of their intrauterine device.”

This study conducted by researchers at the University of Hawaii investigated whether women with IUDs inserted were actually willing and able to perform the recommended monthly self-checks of the IUD threads. Their study found that only 46% of the women surveyed were willing or able to perform the check either at home or during a clinical visit. As a result, they found there was no benefit in routinely reminding women to perform the self-check if the barriers to checking are cultural or emotional (not feeling comfortable checking), or if they are not physically able to feel them (the length of the threads are too short). Either way, this article explores how social relations can affect whether certain features of a technology are used according to how the creators intended them to be used.

Planned Parenthood. “IUD Birth Control | Info About Mirena & ParaGard IUDs.

https://www.plannedparenthood.org/learn/birth-control/iud

This is an educational resource created by Planned Parenthood, a nonprofit organization dedicated to comprehensive women’s health. Planned Parenthood is constantly in jeopardy of losing federal funding needed to provide women’s health and family planning services, as many conservative stakeholders are opposed to the services they provide. This context is important in understanding the sociotechnical system in which Mirena and information around women’s contraceptive options exist. This resource makes accessible the different kinds of IUDs that are available, but does not provide comprehensive information on any one kind in the way that our project aims to do. It is very useful as a comparison of other brands and types of IUDs that are available, as well as the costs associated with them.

Praderio, Caroline. 2017. “Your IUD May Last Way Longer than Your Doctor Is Telling You.” 

http://www.thisisinsider.com/mirena-lasts-7-years-paragard-lasts-12-years-iud-2017-5

Mirena is FDA-approved for up to five years of use, but recent studies have shown that it is effective up to seven years. This article explains why this information hasn’t being made public–a combination of small sample sizes in the research, as well as other limitations. One such limitation explains the studies done on extended use of Mirena have focused on their use by women who first had the Mirena inserted when they were at least 25 years old and already had one child, and has not yet been tested on women who are younger than 25, or have not had any children. The author also argues that the manufacturers of IUDs prefer users to replace their IUDs every five years instead of every seven years for their financial benefit. This article emphasizes that we should remain critical of the information provided by the manufacturer of Mirena and expand research beyond Bayer’s documents.

 

Shambhu, S. 2009. “The Lost Mirena: What Investigations Are Required ? An Intraperitoneal Levonorgestrel-Releasing Intrauterine System Following Uterine Perforation: Case Report”

http://www.bjmp.org/content/lost-mirena-what-investigations-are-required-intraperitoneal-levonorgestrel-releasing-intrau

This case study explores how a “lost” Mirena IUD is found when the uterus lining has been perforated. In the case in question, a missing Mirena was found four years after its insertion. It was known to no longer be in the uterus as it did not appear on ultrasounds or in pelvic examinations. This lost Mirena was found when the patient underwent an abdominal X-Ray. This is because Mirena is radiopaque, which means it is impenetrable by radiation, and is therefore visible on X-Rays. This is an example of the usefulness of Mirena’s architecture and the materials used in its development.

Thiery, Michel. 1997. “Pioneers of the intrauterine device.” European Journal of Contraception and Reproductive Health Care. 2 (1): 15–23.

This article details the tumultuous history of the intrauterine device beginning at the introduction of the Grafenberg intrauterine ring in 1928. It provides a comprehensive history of the development of several intrauterine devices, including explaining why metallic devices fell out of favor due to the difficulties of insertion, which paved the way for the flexible plastic frame of the Mirena. It also details a major drawback of IUD use for women’s health– that this technology does not protect women from sexually transmitted infections. This article assisted in our communications of Mirena’s limitations, in order to help women make informed decision about whether the Mirena is the right method for them.

css.php