Dalkon Shield Research Articles

The Fall of the Nation's First Gender-Affirming Surgery Clinic.

Johns Hopkins Hospital established the first gender-affirming surgery (GAS) clinic in the United States in 1966. Operating for more than 13 years, the clinic was abruptly closed in 1979. According to the hospital, the decision was made in response to objective evidence claiming that GAS was ineffective. However, this evidence directly contradicted many contemporaneous studies and faced immediate criticism from the scientific community. Despite this resistance, it took the hospital nearly 40 years to resume performing GAS. Scientific evidence-imbued in scandal, bias, and moralism-was instrumentalized to serve broader institutional interests. The burgeoning field of plastic surgery tethered and then untethered GAS from its auspices in response to poor technical outcomes and transphobia. No longer serving surgeons' interests, the clinic was marginalized to "barely minimal facilities" in 1974, five years before GAS was formally banned. Over the next 5 years, the clinic co-inhabited space with the Department of Obstetrics and Gynecology. Simultaneously, the Department of Obstetrics and Gynecology navigated scandals related to reproductive technology (namely, the Dalkon Shield [A.H. Robins] controversy) until the clinic space was demolished in 1979. The study that informed the GAS ban was preferentially funded in keeping with the political economy of biomedical research. This article presents a spatial argument for how the closure of the nation's first GAS clinic was not based in empirical data alone but was manipulated to fuel political and institutional agendas.

FDA Device Oversight From 1906 to the Present.

This article examines the history of device oversight by the US Food and Drug Administration (FDA). Significant regulatory changes occurred in response to injuries caused by Dalkon Shield intrauterine devices. This article summarizes those changes as well as continued efforts by the FDA to strengthen device oversight and address areas of concern.

Intrauterine device use, sexually transmitted infections, and fertility: a prospective cohort study

In the 1970s, numerous medical reports, media coverage, and litigation around the Dalkon Shield intrauterine device led to a perception that all intrauterine devices cause upper genital tract infection and infertility. This study aimed to assess the association between intrauterine device use and time to conception. The Fertility After Contraceptive Termination Study is a multicenter, prospective cohort study of women stopping their contraceptive method to attempt conception. We recruited participants between 2011 and 2017. Participants were a convenience sample of women recruited from academic centers in Philadelphia, PA; Los Angeles, CA; St. Louis, MO; Indianapolis, IN; Aurora, CO; and Salt Lake City, UT. Women were eligible if they stopped their contraceptive method within the past 120 days before enrollment, were between 18 and 35 years of age, had no history of infertility or sterilization, and had at least 6 months of follow-up. Baseline data included demographic and reproductive characteristics, past contraceptive use, nucleic acid amplification testing for sexually transmitted infections, and serology for past infection with Chlamydia trachomatis, Trichomonas vaginalis, and Mycoplasma genitalium. The primary exposure was intrauterine device use (ever); the primary outcome was time to conception. All participants were observed longitudinally for up to 24 months. We used piecewise exponential proportional hazards models with multiple imputation to provide hazard ratios and their respective 95% confidence intervals. Of the 461 participants, mean age was 28.2 years, 178 (38.7%) were Black, 157 (34.1%) were considered as low socioeconomic status, and 275 (59.7%) had a history of intrauterine device use. Without adjusting for any covariates, the median time to conception was shorter for participants who had a history of intrauterine device use (5.1 months) than participants who never used an intrauterine device (7.5 months). After controlling for potential confounders, the association of past intrauterine device use with time to conception was not statistically significant (adjusted hazard ratio, 1.25; 95% confidence interval, 0.99-1.58). In our multivariable model, age, nulligravidity, Black race, low socioeconomic status, and past Mycoplasma genitalium infection were associated with longer times to conception (hazard ratio, 0.76; 95% confidence interval, 0.58-0.99). Conception by 12 months was lower in participants with past Mycoplasma genitalium infection (68% vs 80% without past infection; P=.019). We found no impairment of fertility with ever use of an intrauterine device. Serologic evidence of past Mycoplasma genitalium infection was associated with longer times to conception and higher rates of infertility. Mycoplasma genitalium infection is a potential modifiable cause of infertility.

The Comeback of the IUD in Twenty-First Century USA.

From 1995 to 2014, intrauterine devices (IUDs) rose from ranking 10th (out of 11) among contraceptive methods to being the fourth most popular, outnumbered only by the pill, sterilization, and condoms. In 1995, the IUD had been largely abandoned by American doctors; two decades later, major medical associations promoted it as a "first line" method for prospective users of all ages. This paper explains the rapid and dramatic increase in intrauterine contraception by exploring three influential factors from the 1970s-1980s - the Dalkon Shield disaster, the lack of innovation in contraceptive research and development, and the moral panic over teen pregnancy in America - that created circumstances by the early 2000s in which health care providers became more receptive to long-acting reversible contraception. Key thought leaders in obstetrics and gynecology took it upon themselves to rehabilitate the IUD in the court of medical opinion and succeeded in securing professional approval of the device as the initial step in its resurrection.

Time to Conception After Use of Contraception

Concerns that intrauterine contraception (IUC) may adversely affect fertility date back to the Dalkon shield, which was removed from the market in

Protect Pregnant and Lactating Women with COVID-19 Through Research, Not from Research.

Protect Pregnant and Lactating Women with COVID-19 Through Research, Not from Research.

Dispositif intra-utérin et infections génitales hautes : mythe ou réalité ?

IntroductionIntrauterine device (IUD) is a reliable contraceptive method that is long term reversible, and well tolerated. Numerous studies prove its efficiency and report rare complications that are attributed to it. However, its use is limited due to fear that it can cause a pelvic inflammatory disease (PID). This is based on historical data on infections related to the “Dalkon Shield”, which was removed from the market in 1974. MethodThe analyzed articles were extracted from PUBMED database between 2000 and 2016. In total, 22 studies were retained. A meta-analysis was not possible due to the methodological diversity among the selected articles contributing to this narrative review of the literature. ResultsAfter analysis, the following factors influence the risk of PID linked to IUDs: an advanced age and sexually transmitted infections. ConclusionThe risk of PID linked to IUDs is lower than 1%. This is explained by new models of IUD, better screening tests, more frequent follow-up of the patients and the improvement of care PID patients. In the light of our results, the threat of pelvic inflammatory disease should not hinder the use of IUDs.

Comparison of genital microbial isolates between intrauterine contraceptive device users and nonusers in Sokoto, Nigeria

Background: In the past, the use of intrauterine contraceptive device (IUCD), in particular, Dalkon Shield was found to be associated with increased risk of pelvic infection. Recent literature illustrates that the risk of pelvic infection after insertion of an IUCD is low and that the risk peaks in the 1 st month after insertion. We set out to determine the incidence of genital infection among IUCD users after the 1 st and 3 rd months of insertion compared to users of other contraceptive methods; to determine the risk of genital infections among IUCD users compared to users of other contraceptive methods and to determine the organisms associated with genital infection among the contraceptive users. Materials and Methods: This was a cohort study involving new clients who chose various forms of contraceptives. Results: The incidence of genital infection was 3 (8.5%) at 1 month and 4 (12.1%) at 3 months. The incidence in non‑IUCD contraceptive users was 2 (5.9%) at 1 month and 3 (8.8%) at 3 months. The relative risk was 1.44 and 1.5 at 1 and 3 months, respectively. The observed difference in the rate of infection between IUCD users and other contraceptive users was not statistically significant. Bacteria vaginosis and Trichomonas vaginalis were commonly observed in the two groups. Conclusion: The incidence of genital infection among IUCD users was relatively low compared to non‑IUCD users. IUCD s do not significantly increase the of rate genital infection. Keywords: Contraceptives; genital; infection; intrauterine contraceptive device; Nigeria

"This is not a Dalkon Shield": The Renaissance of the Intrauterine Device in the United States

"This is not a Dalkon Shield": The Renaissance of the Intrauterine Device in the United States

Impact of Years of Clinical Experience on Perceived Contraindications and Barriers to the Use of LARC: A Survey of Family Planning Providers

BackgroundDespite their efficacy in preventing unintended pregnancies, intrauterine devices (IUDs) are still relatively underutilized by American women. Although cost of these methods is clearly a barrier to use, IUDs have had a long and sometimes controversial history, and earlier versions were removed from the market. MethodsThis study explores the degree to which the length of licensure for providers is related to their attitudes toward or fears about these methods. Data come from a 2012 survey of 114 clinicians in Colorado and Iowa, collected as part of two, statewide initiatives to reduce unintended pregnancy. Providers were asked about service barriers to prescribing these methods and for which patients they perceived them to be suitable and safe. ResultsThe most experienced clinicians were the least concerned about uterine perforation and history of the Dalkon Shield, but were more likely to fear a lawsuit over complications. More experienced clinicians were also less approving of Copper T IUDs for all 11 subgroups of women, including nulliparous women and those with histories of sexually transmitted infections. They were also less approving of hormonal IUDs for 10 groups of women, including those with histories of ectopic pregnancies. However, clinicians with the most recent licensure were more conservative in their approval of single rod implants than were the providers with the most years since licensure. ConclusionsThis paper explores potential reasons for these findings and suggests trainings to recognize and overcome these barriers so as to promote consistent and accurate practice across clinicians, regardless of years of experience.

Lessons Learned by the Reporter: Is Disaggregation the Answer to the Asbestos Mess?

Described as an “elephantine mass” that “defies customary judicial administration,” asbestos litigation remains the longest-running mass tort in U.S. history. Ultimately, the efforts made to resolve the ever-expanding asbestos litigation failed. In 1997, in Amchem Products, Inc. v. Windsor, the United States Supreme Court struck down the use of a class action settlement to achieve a global resolution of all asbestos claims — those pending at the time and those of future claimants. In the wake of Amchem, dozens of asbestos defendants sought bankruptcy protection while plaintiffs continued to file claims in state and federal courts. Between 1988 and 2010, a United States Government Accountability Office (GAO) analysis of the approximately 100 bankruptcy trusts’ payment data showed that the asbestos trusts had paid about $17.5 billion to 3.3 million claimants. Since then, much has happened but basic problems remain. The patchwork system of plaintiffs claiming in federal and state courts, as well as the separate administrative claiming before bankruptcy trusts, raises complicated issues about how injured persons can be properly compensated while assuring that defendants are not assessed damages that are not warranted, and how to protect the trusts from fraud and preserve trust funds for future meritorious claimants.The American Bar Association Torts and Insurance Section appointed a Task Force to look into issues currently confronting asbestos stakeholders. I was appointed its Reporter. This Article focuses on how the Task Force went about its work and developed a record. It then presents some thoughts on how my service brought together my long-standing academic interest in how mass torts ought to be resolved and the realities of the current asbestos litigation. What I have learned thus far has led me to question my once zealous advocacy of aggregated mass tort claims resolution.When I served as Chairperson of the Dalkon Shield Claimant’s Trust, I wrote articles that focused on how the Trust resolved hundreds of thousands of claims. It is fair to say that I was a fan of aggregate resolution of mass torts. In my view, the use of multidistrict litigation, class actions, other aggregation tools, and even Chapter 11 reorganization provided fair and efficient vehicles for the resolution of mass torts. Indeed, the Dalkon Shield Board of Trustees expressly adopted motivating principles as they began to put meat on the bones of the CRF. First, and foremost, among these principles, was to “[t]reat all claimants fairly and equally, always focusing on the best interests of claimants collectively instead of on the interests of a particular claimant or group of claimants.” Another principle harkened back to the first: “Prefer settlement and prompt payment of claims over arbitration and litigation.” Rereading these principles in light of the compelling testimony of two of the Task Force witnesses challenged my weltanschauung about mass tort dispute resolution. Judge Robreno’s and Judge Davidson’s testimony about disaggregating cases into their core components, “letting lawyers be lawyers,” and getting cases ready for trial instead of obsessing about global or individual settlements is what led to the successful resolution of the cases before them.Moreover, Judge Robreno’s testimony suggests that attempts at aggregated resolution of the “elephantine mass” were all failures, except for the MDL itself, which has largely wrapped up its work. Rather, as Judges Robreno and Davidson testified, the disaggregation of asbestos claims allowed asbestos cases to be prepared for trial (or settlement discussions) more expeditiously. Now, dying plaintiffs can get a shot at a prompt trial date rather than having to wait out a global settlement. Perhaps tending to the needs of particular plaintiffs is the best way to protect the interests of the whole in mass tort litigation after all.

Intra-abdominal Dalkon Shield IUD: Lost for Over 30 Years

A 64-year-old woman with a long history of intermittent left lower quadrant pain and ovarian cysts came for consultation. A computed tomography scan ordered by her referring physician revealed a retained Dalkon Shield intrauterine device (IUD) in the left mid-abdomen (Fig. 1 and Fig. 2). A 1.5 × 1.5 × 1.3-cm complex left ovarian cyst was also observed. The patient reported having a Dalkon Shield inserted greater than 30 years previously but presumed it had been expelled shortly after insertion. She underwent an uneventful laparoscopic removal of the Dalkon Shield, found embedded in the transverse colonic omentum, as well as a laparoscopic left-sided salpingo-oophorectomy.

The levonorgestrel-releasing intrauterine system: Safety, efficacy, and patient acceptability

The levonorgestrel-releasing intrauterine system (LNG-IUS) is a safe, effective and acceptable form of contraception used by over 150 million women worldwide. It also has a variety of noncontraceptive benefits including treatment for menorrhagia, endometriosis, and endometrial hyperplasia. The LNG-IUS has also been used in combination with estrogen for hormone replacement therapy and as an alternative to hysterectomy. Overall, the system is very well tolerated and patient satisfaction is quite high when proper education regarding possible side effects is provided. However, despite all of the obvious benefits of the LNG-IUS, utilization rates remain quite low in the developed countries, especially in the United States. This is thought to be largely secondary to the persistent negative impressions from the Dalkon Shield intrauterine experience in the 1970s. This history continues to negatively influence the opinions of both patients and health care providers with regards to intrauterine devices. Providers should resolve to educate themselves and their patients on the current indications and uses for this device, as it, and intrauterine contraception in general, remains a largely underutilized approach to a variety of women's health issues.

Winning hearts and minds in Iraq through mediated condolence payments

AbstractJeremy Joseph of Washington, D.C., proposes expanding condolence payments in Iraq, in which the military would compensate innocent victims of U.S. operations, in a manner similar to the Dalkon Shield and 2001 Victim Compensation Fund claims facilities. The article is an updated adaptation of a longer piece for which the author received a 2006 CPR Award for Excellence in ADR

Good reasons to reconsider the copper intrauterine device for contraception

Modern Copper Intrauterine Devices [Cu IUDs] are extremely safe highly effective long acting yet rapidly reversible contraceptives. They are also very cost effective and suitable for use by a wide range of women including nulliparous as well as HIV infected women. Despite a large body of scientific evidence attesting to its safety and efficacy the IUD remains underutilized except in a few countries such as China where it provides 43% of contraceptive use. Use in other countries varies from a low 1% in USA 5% in UK to around 20% in France and Germany. The DHS (1998) reported that Cu IUDs accounted for less than 3% of total contraceptive use in South Africa. Much of the resistance to use can be traced back in history. Various IUDs were developed in the early 1900s but only achieved wide acceptance in the 1960s in the form of the Lippes Loop. In the 70s reports of numerous pregnancies many of which resulted in septic spontaneous miscarriages with several maternal deaths were associated with the use of the Dalkon Shield a device specifically marketed for nullipara. Clearly this device was of poor design being far less effective than other IUDs of the time. More important was the unique structure of the multifilament thread passing through the cervix all other IUDs had monofilament threads. This braided thread acted like a wick actively drawing infection up from the lower genital tract. The Dalkon Shield was taken off the market and the manufacturer forced out of business by massive litigation. Sadly but perhaps not surprisingly both the public and health professionals alike regarded all IUDs in the same light despite clear evidence to the contrary. This was the start of the IUDs undeserved reputation for causing pelvic inflammatory disease [PID] and fears about subsequent infertility. (authors)

Clinic Opinions Regarding IUCD Use in Adolescents

The intrauterine contraceptive device (IUCD) has been a method of contraception used for centuries, worldwide. Although the IUCD is a widely accepted and utilized method of contraception throughout Europe and China, only 0.8% of women in North America aged 15 to 44 years are using the IUCD for contraception.1 In a 1999 survey, 9% to 24% of women in five European countries and 33% of Chinese women using contraception were utilizing the IUCD.2 Misconceptions regarding the IUCD likely propagated by the circumstances surrounding the Dalkon Shield in the 1970s may be the critical event leading to practitioners' apprehension of recommending the IUCD as a safe and effective contraceptive method.

Quality, Not Quantity: An Analysis of Confidential Settlements and Litigants' Economic Incentives

The recent rise of “sunshine” legislation, which prohibits or reduces secret settlements of civil lawsuits, highlights public unease with confidential settlements. Recurring, highly publicized, dangerous events expose the costs of confidentiality: the Bridgestone/Firestone tire scandal and the Catholic Church sex abuse scandal are the most recent. Litigation regarding the Dalkon Shield, the Ford Pinto, and

Mass Torts Bankruptcies: The Who, the Why, and the How

For the last several decades, federal and state courts, with varying degrees of cooperation from the parties and lawyers involved, have developed ways of managing the complex mass tort cases confronting them. A key development was the emergence of the idea of using consolidation techniques to achieve global peace in the resolution of these often seemingly intractable cases. In the wake of the Supreme Court's decisions in Amchem and Ortiz, however, the use of class actions to achieve global peace became problematic. Meanwhile, Chapter 11 proceedings under the bankruptcy laws emerged as a vehicle for achieving global peace. Especially after Amchem, it appears that the use of Chapter 11, despite the problems raised for a defendant corporation, may be the best tool for achieving global peace. This working paper provides a brief history of the three leading mass tort bankruptcy cases: the Johns Manville Chapter 11 case involving asbestos personal injury claims, the A.H. Robins Chapter 11 case involving Dalkon Shield claims, and the Dow Corning Chapter 11 case involving breast implant claims. The purpose of the review of these cases is to highlight the important practical and doctrinal issues raised by the use of Chapter 11 as a vehicle for resolving mass tort litigation.

Control and the Dalkon Shield

This article analyzes how medical and scientific discourses surrounding the Dalkon Shield legitimized and authorized the punishment and control of women's bodies. Women who used, or were targeted as potential users of, the Dalkon Shield intrauterine device were judged according to normative constructions of sex, hegemonic heterosexuality, and race. Eugenics and population control discourses were significant in classifying particular women as inferior and abnormal. Via pathologizing discourses and practices, the reproduction and sexual capacities of women, as a sexed group, were targeted and disciplined.

THE INTRAUTERINE CONTRACEPTIVE DEVICE

The intrinsic appeal of the convenience and effectiveness of the IUD has increased interest in these devices in the United States in recent years. Understanding the uniqueness of the Dalkon Shield experience and applying the lessons learned about appropriate candidate selection should continue to reduce any lingering liability concerns. One lawsuit has been filed against the copper IUD in the 12 years that it has been available in the United States. If legislation requiring insurance coverage for IUDs and other prescription contraceptive agents continues to be passed by more states, the use of IUDs will continue to grow. The introduction of new IUDs with different side-effect profiles will expand the number of US women who can and will be interested in using this method of birth control.