These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: The Dalkon Shield debate.
    Author: Goodhue PA.
    Journal: Conn Med; 1983 Mar; 47(3):138-41. PubMed ID: 6851548.
    Abstract:
    The literature seems to have settled the controversy among physicians as to whether or not the Dalkon Shield is the real culprit in the relationship between IUD use and pelvic inflammatory disease (PID). This review of the literature suggests that all types of IUDs in use have the potential to enhance PID. The Dalkon Shield debate today is primarily between attorneys for A.H. Robins and attorneys for Plaintiffs who claim injury from PID and infected pregnancies. The National Law Journal on January 11, 1982 reported that in July 1979 a jury in Denver, Colorado awarded a patient $600,000 in compensatory damages and $6.2 million punitive damages against A.H. Robins, maker of the Dalkon Shield. Already verdicts and settlements against Robins in some 3200 cases have cost the company about $69 million. More than 1500 lawsuits are pending, seeking a total of $2.8 billion in compensatory and punitive damages from Robins. In view of this information another review of the literature is not superfluous. Clinical experience proved that the Dalkon Shield was the 1 IUD most likely not to be expelled. The disadvantages were pain on insertion and removal. Many of this doctor's patients, especially those who were nulliparous, experienced syncopal attacks on insertion. The clinical experience was also that the contraceptive failure rate was greater than the reported 1.1%. For these reasons Dalkon Shield insertions were stopped. Pelvic infection was not a determining factor in abandoning the use of the Dalkon Shield. A most damaging study for the Dalkon Shield appeared in June 1974. Christian reported 5 midtrimester maternal deaths and 7 cases of septic abortion associated with IUD usage. The Dalkon Shield was involved in 10 cases, and 2 cases involved the Lippes Loop. This report created suspicion that there might be something about the design of the Dalkon Shield that allows dissemination of infection. June 28, 1974 Robins voluntarily suspended domestic distribution of the Dalkon Shield at the request of the US Food and Drug Administration, but there was no recall of the device until September 1980. An extensive study in 1977 by Eschenbach et al. concluded that IUD users have a 4.4 times greater risk of developing PID than nonusers, and no particular type of IUD was found to be disproportionately associated with PID. Purrer et al. in 1979 published a 2nd in vitro study on IUD tails exposed to pathogenic bacteria. The study totally disagreed with the conclusions of Tatum that condemned the multifilament tail of the Dalkon Shield. In sum the Dalkon Shield debate is no longer of clinical significance.
    [Abstract] [Full Text] [Related] [New Search]