Clinical experience with the Dalkon Shield intrauterine device

Area of Science:

• Reproductive Health
• Medical Device Technology
• Contraception

Background:

• The Dalkon Shield was developed as a novel intrauterine device (IUD) for contraception.
• Previous trials by developers claimed high efficacy and safety.
• Understanding real-world performance is crucial for medical device evaluation.

Purpose of the Study:

• To assess the preliminary acceptability and reliability of the Dalkon Shield.
• To evaluate key performance metrics such as pregnancy and expulsion rates.
• To compare the Dalkon Shield's performance against existing intrauterine contraception methods.

Main Methods:

• A prospective study involving 377 women using the Dalkon Shield.
• Data collected over 17 months, totaling 3,028 months of device use.
• Achieved a high follow-up rate of 98% to ensure comprehensive data.

Main Results:

• Observed a pregnancy rate of 4.7% and an expulsion rate of 6.3%.
• These rates did not align with the efficacy claims made by the Dalkon Shield's developers.
• The Dalkon Shield demonstrated a lower expulsion rate compared to "first-generation" inert IUDs.

Conclusions:

• The Dalkon Shield's performance in terms of pregnancy and expulsion rates requires further investigation.
• Despite not meeting initial claims, the device shows potential as an improvement over older intrauterine devices due to reduced expulsion.
• Further research is warranted to fully understand the Dalkon Shield's long-term safety and efficacy profile.