Based on clinical experience it can be assumed that the US Food and Drug Administration (FDA) is the most frequently consulted health agency. Millions of consumers take it for granted that the FDA as the highest authority in matters of food and drugs is reliable. Unfortunately, the FDA does not stand up to these expectations in the area of birth control and contraception because its most recent Chart of Birth Control Methods [1] is incomplete, mentions only a limited number of trivial adverse events, and presents data on efficacy which make it impossible to distinguish the most effective methods from those that are less effective.

Similar to an earlier published ranking — the “FDA Approved Methods of Birth Control” of 2013 [2] — the new chart of 2018 fails to address the parameter safety. Instead, it contains only a small rubric entitled “some risks or side effects.” Unfortunately, this rubric is incomplete and provides only rudimentary information by using vague terminology. Thus, in the case of intrauterine devices the most feared complications, namely pelvic inflammatory disease (PID), perforation, and expulsion, are not mentioned at all. Instead of drawing attention to these well-known adverse events, only a few side effects are enumerated, namely “Irregular bleeding. No periods (amenorrhea). Abdominal/pelvic pain” [1].

For implants, there is no indication of the risk of dislocation and migration to the pulmonary artery or of breakage of the device already during insertion; rather, only trivial symptoms — commonly attributed to oral hormonal contraceptives — are mentioned, namely “Menstrual Changes, Mood swings or depressed mood, Weight gain, Headache, Acne” [1]. The device ranked in second place and described as sterilization is no longer available because it has been withdrawn from the market in 2018 by the manufacturer due to thousands of lawsuits and complaints by women worldwide who had experienced severe harm caused by the device [3].

Besides describing a device that is no longer available on the market due to the harm experienced by users, the FDA chart suffers from another fundamental flaw, namely a lack of precision regarding efficacy. The imprecise data on efficacy are misleading because the terminology used “less than one” makes it impossible for the consumer to perceive that implants are far more effective than other methods. While the estimates presented by Contraceptive Technology [4], the World Health Organization (WHO) [5], and the Synoptic Overview of Contraceptive Methods Methods [6] indicate the superiority of implants (owing to an estimate of 0.05) and the inferiority of intrauterine devices (due to an estimate of 0.89) the FDA chart makes it impossible to recognize the undisputed superiority of implants. The FDA chart misleads the consumer into believing that there is no difference in efficacy between implants and intrauterine devices. As a consequence, women are at risk to choose inappropriate methods, and quite a number of them might incur harm because they could not identify the most effective among all the methods due to the unscientific designation “less than one” chosen by the FDA.

The risk of choosing an inappropriate method looms large also due to another flaw in the FDA chart, namely the omission of natural methods which are commonly included in surveys, as can be seen from the WHO survey [5], the Contraceptive Technology Failure table [4], and the Synoptic Overview of Contraceptive Methods [6].

The natural methods omitted in the FDA chart are internationally acknowledged and belong to the safest of all methods [7]. The importance of these natural methods particularly for women who do not tolerate hormones or devices has been highlighted infrequent publications, including the one by the American Congress of Obstetricians and Gynecologists (ACOG). In these publications, the ACOG rectifies previous comments and emphasizes the advantages of the Fertility awareness-based Methods, namely low cost and the absence of adverse events caused by medications: “They cost very little… Many women like the fact that fertility awareness is a form of birth control that does not involve the use of medications or devices” [8].

Another area where these methods are appreciated is research on HIV. In an investigation on serodiscordant couples, the Fertility Awareness Methods (FAM) appeared as particularly suitable, and the authors concluded: “FAMs provide effective, economical, and accessible options for HIV serodiscordant couples to conceive while minimizing unnecessary viral exposure” [9].

By omitting these methods also in its latest chart of 2018, the FDA violates again — as in the 2013 published survey [2] — the principle of informed consent and denies women the right of self-decision [10]. As is known, this principle requires completeness of information so that the patient is enabled to make “an intelligent choice” [11]. The FDA chart does not enable women to make an intelligent choice because they are lacking vital information about several methods which are not only the safest but range in perfect use efficacy higher than some hormonal methods, namely from 0.8 (symptothermal ) to 4 (Standard Days Method) [4]. In failing to provide complete information on safety and efficacy, the FDA not only ignores the fundamental bioethical principle of nil nocere (no harm) but also infringes on civil law through negligent misrepresentations.

The FDA’s failure to comply with the principle of informed consent appears particularly problematic from the perspective of consumers’ rights because as early as 2013 similarly negligent information had been proposed by the FDA. The 2013 version was entitled FDA “Food and Drug Administration (FDA) Approved Methods of Birth Control” [2]. In this ranking, percentages are indicated for the “number of women out of 100 who will not get pregnant”, and the usual distinction is made between “perfect” and “typical” use. According to this FDA survey, several methods achieve more than 99 percent for both perfect and typical use, namely Sterilization Surgery for Women, Surgical Sterilization Implant for Women, Sterilization Surgery for Men, Implantable Rod, and IUD. These percentages are indicated in the FDA survey as follows:

Sterilization Surgery for Women >99%

Surgical Sterilization Implant for Women >99%

Sterilization Surgery for Men >99%

Implantable Rod >99%

IUD >99%

As can be seen, all the above-listed methods are rated as equally effective in both perfect and typical use and are ranked higher than those whose typical use estimates are inferior to their perfect use estimates, namely:

• Shot/Injection >99% perfect use (91% typical use)

• Oral Contraceptives (Combined pill: “The Pill“) >99% perfect use (91% typical use)

• Oral Contraceptives (Progestin-only: “The Pill“) >99% perfect use (91% typical use)

• Oral Contraceptives (Extended/Continuous use: “The Pill“) >99% perfect use (91% typical use)

• Patch >99 perfect use (91% typical use)

• Vaginal Contraceptive Ring >99 perfect use (91% typical use)

Among the less effective methods are Male Condom (98% perfect use – 82% typical use); Diaphragm with Spermicide (94% perfect use – 88% typical use); Sponge with Spermicide (80-91% perfect use – 76-88% typical use); Cervical Cap with Spermicide (74% perfect use – 60% typical use); Female Condom (95% perfect use – 79% typical use); Spermicide (82% perfect use – 72% typical use).

Besides indicating misleading estimates for efficacy the FDA survey presents controversial information on Emergency Contraception (EC). As EC pills are administered a posteriori, the relevant estimates are purely hypothetical because they are based on prospective assumptions. Besides indicating the controversial estimate of 85% for EC, the FDA erroneously recommends that EC should not be used as a regular form of birth control and should be implemented within 70 to 120 hours of unprotected coitus. Contrary to this recommendation by the FDA new research has shown that EC can be used as a regular form of birth control, especially by women whose sexual activity is reduced to no more than one incidence per month [12,13].

In a comparison of this FDA survey with the table proposed by Contraceptive Technology [4], it becomes obvious that the FDA survey lacks the precision inherent in reliable tables and charts. While the latter show unambiguously that the implant Implanon (precursor of Nexplanon) with a 0.05 failure rate for both perfect and typical use is by far more effective than all the other methods, the FDA survey does not reflect this superiority. Consequently, the woman who opts for the ParaGard (copper T) intrauterine device (<99% for both typical and perfect use according to FDA) does so in neglect of all those methods whose perfect use failure rates are superior to ParaGard’s perfect use failure rate of 0.6, namely implants (0.05), Mirena (LNg) (0.2), Depo-Provera (0.2), NuvaRing (0.3), Evra patch (0.3), or combined pill and progestin-only pill (0.3) [4].

As can be seen, the FDA perpetuates the errors which had been disseminated already in the 2013 FDA Approved Methods of Birth Control. Both these charts present misleading information, and quite a several women who follow FDA guidelines might choose an inappropriate method and incur substantial financial damage. In the same vein, from an economic viewpoint, the question arises what kind of costs for the taxpayer result from medical treatments due to harm caused by an inappropriate method. A similar question concerns the economic damage resulting from the distribution of thousands of error-prone free publications for consumers as well as the payroll costs for incompetent federal employees who disseminate flawed science.

The burden for the taxpayer resulting from the distribution of misleading information material comes to the forefront also in other rankings such as the one proposed by the Center for Disease Control (CDC) in 2015 [14] or by Planned Parenthood [15].