Another look at the Dalkon Shield: meta-analysis underscores its problems

Area of Science:

• Reproductive Health
• Medical Device Safety
• Public Health

Background:

• Non-comparative studies suggested the Dalkon Shield intrauterine device (IUD) was effective and safe.
• Concerns existed regarding its safety profile compared to contemporary IUDs like the Lippes Loop and Copper IUDs.

Purpose of the Study:

• To compare the safety and efficacy of the Dalkon Shield IUD with other intrauterine devices (IUDs) using randomized study data.
• To investigate the specific risks associated with Dalkon Shield use, including pregnancy, pelvic infection, and mortality.

Main Methods:

• Analysis of randomized clinical trials and observational studies, including the Women's Health Study.
• Comparison of pregnancy rates, expulsion rates, pelvic inflammatory disease (PID) severity, septic abortions, and mortality between Dalkon Shield users and users of other IUDs.

Main Results:

• The Dalkon Shield exhibited approximately double the pregnancy rates and lower expulsion rates compared to Lippes Loop D or Copper IUDs.
• Users of the Dalkon Shield faced a five-fold increased risk of hospitalized pelvic infection, with more severe cases of PID.
• The multifilament tail of the Dalkon Shield was linked to higher rates of pregnancy complications, including septic abortions and deaths.

Conclusions:

• The Dalkon Shield IUD's performance was not equivalent to contemporary IUDs, demonstrating significantly higher risks for several adverse outcomes.
• The unique design of the Dalkon Shield contributed to its increased complication rates.
• Post-cessation of Dalkon Shield use and adherence to FDA recommendations have coincided with a significant reduction in IUD-related deaths.