Gynecologist Paul R. Packer read the promotional brochures that came with the new intrauterine device called the Dalkon Shield: safe, effective and so easy to insert that it "is generally well tolerated by even the most sensitive women." What Packer said he discovered in his suburban New York practice was very different.
On Feb. 11, 1971 -- six weeks after A.H. Robins Co. began selling the device -- Packer wrote Robins: "I have just inserted my 10th Dalkon Shield and have found that procedure to be the most traumatic manipulation ever perpetrated upon womanhood . . . . I have ordered all Shields out of my office . . . . "
Packer was not alone. During the next 42 months that the Shield was sold, many women and their doctors found it hard to square the sometimes agonizing experiences in the clinic with the ease and comfort described by the company in its marketing campaign.
That campaign emphasized that the Shield was safe, effective and easy to use. These claims catapulted Robins, which had no previous experience with birth control products, to the top of the IUD market. In the peak month, about 88,000 Shields were inserted.
The company waged a marketing blitz, distributing millions of promotional brochures. It made Shield sales a priority for its more than 500 sales people. In February 1971 -- the month that Packer wrote to the company -- a Robins manager, E.D. Hood, sent this telegram to his salesmen: "Northern Division will not be humiliated by a lack of Dalkon sales. If you have not sold at least 25 packages of eight, then you are instructed to call me. Be prepared to give me your call-back figures. No excuses or hedging will be tolerated, or look for another occupation."
From internal memos and interviews, it appears that Robins officials believed the company's initial claims of the Shield's superiority. But those claims increasingly were challenged in physician and consumer complaints and by reports of pregnancies, miscarriages, infections and even deaths.
"We responded as any responsible company would," said a Robins spokesman, Roscoe Puckett. "Our people investigated the claims to get to the bottom of them and resolve them . . . you anticipate a certain number of complications from not only the Dalkon Shield but any IUD . . . . When you're dealing with a million people, you're going to have these problems." Early Misgivings
Early on, some expressed misgivings about the Shield and its potential to cause pain. Dalkon Corp. had offered the device to Schmid Laboratories in 1969. A former Schmid official, in an interview, said the Shield, a nickel-sized piece of plastic with four or five small feet on each side, reminded him of "a grappling hook."
In August 1970 -- four months before Robins began selling the device -- several physicians expressed concerns to Robins. Some were enthusiastic about it, but a few, according to the market research department, "were appalled by what they considered the 'frightening' looks of the device and were very concerned with the possibility of these fins tearing into the uterus upon withdrawal."
A company spokesman said that the appearance of the device is irrelevant and that he was not aware of any "documented cases" in which the Shield tore the uterine wall.
Once the Shield was purchased, the company promoted it heavily. For prospective users of the IUD, Robins had a brochure entitled "Answers to Your Questions About the Dalkon Shield." In a question-and-answer format, the company asked: "Where can I have the Dalkon Shield inserted?" Answer: "The Dalkon Shield can be inserted routinely and quickly as part of a regular appointment at the doctor's office or at your family planning clinic."
Another question: "Does it hurt to have the Dalkon Shield inserted?" Answer: "The insertion procedure is generally well tolerated by even the most sensitive women."
Such claims boosted sales but angered some physicians who at times met great difficulty in trying to work the IUD and its inserter through the narrow cervix. Removing the device was often even more difficult.
In a written response to Packer's letter describing insertion of the Shield as "the most traumatic manipulation," Dr. Ellen J. Preston, the company liaison with physicians, conceded that insertion of the Shield "is somewhat more difficult than insertion of other available IUDs." "Answers to Your Questions" did not mention such additional difficulty.
Preston also said for some patients, Robins recommended: 1) premedication with Demerol, a painkiller; 2) atropine, an antispasm drug to protect the patient from pain-induced cardiac arrest; 3) an anesthetic procedure called a paracervical block.
In fact, Preston was quoting from the labeling that had accompanied the Shield when it was sold by its original maker, Dalkon Corp. And in a Robins-sponsored Shield study, the company told researchers that they could use painkillers and anesthetics. But early company brochures aimed at women interested in using the Shield gave little attention to the difficulties of insertion and made no mention of the need for painkillers.
"At the time that Robins put that out," said a company spokesman, "Robins felt that it accurately reflected the experience."
On July 15, 1971, six months after Robins began selling the Shield, Robins' medical experts met and "reviewed complaints" that included "difficult insertion and removal . . . [and] undesirable rate of removal for pain and bleeding during one-two months." The conclusion of the meeting: "While problems are recognized, the overall view is that we are not accumulating information suggesting that we have an 'inferior' product."
The group suggested "our printed literature, exhibits and other instructional methods should be reexamined to determine if there is a better way to inform physicians on how to use the Shield, what pitfalls may arise from use and how to cope with them . . . . In November 1971 Robins removed from its "Answers" brochure the statement that no anesthetic would be needed. It is purely speculative as to whether present design of the Shield is related to pain and bleeding."
Not so speculative, believed Dr. Dorothy I. Lansing. On Aug. 23, 1974 -- two months after the Dalkon Shield was removed from the market because of safety concerns -- Lansing, a gynecologist in surburban Philadelphia, wrote to Frederick A. Clark Jr., Robins medical director and a former classmate at medical school:
"When the Dalkon Shield appeared on the scene, we rejected its use on my say-so. Why? Well -- it is a gruesome-looking little device that I would not allow to be installed within myself -- that's why. Furthermore, with those vicious spikes, its installation would present a serious problem for removal. When I told the Robins salesman 'no,' he was furious and announced we were the only ones not using the Dalkon Shield . . . .
"We have seen several patients with Dalkon Shields put in elsewhere and several have been most difficult to extract in the operating room under anesthesia. I still regard it, the Dalkon Shield, as a poorly designed IUD and a veritable instrument of torture . . . . As a woman physician, I must tell you that I do feel that the device should never have been marketed in the first place . . . . "
A spokesman for Robins said that although insertion of the Shield was difficult for some women, it was not for many others, and that "an overwhelming number of Shields were inserted without using any painkillers." The spokesman said complaints of pain and bleeding are not unique to the Shield. Claims of Effectiveness
The cornerstone of A.H. Robins Co.'s promotional campaign was the Shield's ability to prevent pregnancy. Robins product manager George J. Mancini said in the company's "National (KEY OFF)(KEYWORD)le$ & Marketing Review": "Our strategy in 1973 will be to continue to highlight: 1. Effectiveness (Remember, the Dalkon Shield wouldn't be NUMBER ONE in sales if it wasn't NUMBER ONE in effectiveness.)"
The initial efficacy claims were based on the research of Dr. Hugh J. Davis, the Johns Hopkins University School of Medicine gynecologist who developed the Shield. On Feb. 1, 1970, Davis hailed the Shield as "a first-choice method" in the prestigious American Journal of Obstetrics and Gynecology. Robins purchased the Shield from the Dalkon Corp. -- in which Davis was a stockholder -- on June 12, 1970. Later the company would purchase nearly 200,000 copies of the Davis article for its promotional campaign.
Davis reported in the journal that, in the first year of study, five of 640 women using the Shield became pregnant. The nearly 1.1 percent pregnancy rate was lower than that of any other IUD and nearly as low as that of birth control pills.
However, the 640 women did not each wear a Shield for 12 months. The average use was for fewer than six months. That, said one noted statistician, was not long enough for a reliable assessment of the Shield.
A Robins spokesman said the cumulative experience with the Shield, not the duration of any particular individual's use of the Shield, is what matters.
In internal memos written days before Robins purchased rights to the Shield, two top company physicians -- medical director Frederick A. Clark Jr. and senior vice president Jack Freund -- examined the pregnancy rate in Davis' study and whether that rate would be as low after prolonged use of the IUD.
On June 8, 1970, Clark went to Baltimore to meet with Davis. In a memo the next day, Clark said Davis' article "mentions 640 insertions with five pregnancies. However, data given me for first 14 months . . . covers 832 insertions with 26 pregnancies . . . . "
Another Robins executive appeared to question the pregnancy rates but still believed in the Shield. On June 11 -- the day before Robins bought rights to the device -- Freund told Robins president William L. Zimmer III and other company officers that the pregnancy rate was "2.3 percent" after a "longer followup period." Freund wrote: "The followup period for the published [1.1 percent] pregnancy rate is not long enough (1 year) to project with confidence to the population as a whole . . . .
"In spite of a possibly higher pregnancy rate, other areas of superiority, such as better tolerance and an improved ease of insertion, would suggest that the Dalkon Shield would have an advantage over other competitive intrauterine devices."
A Robins official said the rate of 2.3 percent is not inconsistent with the 1.1 percent reported by Davis, because the rate is cumulative from one year to the next and variations between and even within studies are common.
Davis touted the contraceptive effectiveness of the Shield in his 1971 book, "Intrauterine Devices for Contraception." He submitted the galley proofs of the book to A.H. Robins, which helped pay for the art in the book. Again, Davis hailed the 1.1 percent pregnancy rate.
Robins' claims of effectiveness swept the IUD market. Doctors inserted Shields in more than 2 million U.S. women. But after Shield sales began in January 1971, reports of unwanted pregnancies reached Robins. Some women opted to have babies. Other women had elective abortions or miscarriages thought to be brought on by infections.
In 1972, a sales slump set in. To counter it, Robins prepared a multicolor, eight-page ad. Called "A Progress Report," it ran in medical journals in the last four months of 1972. It cited four published Shield studies and low pregnancy rates. One of the studies was that of Hugh Davis.
A second study was by Dr. Thad J. Earl, who reported a 0.5 percent pregnancy rate over 15 months -- less than half the rate Davis had cited. Earl was a $30,000-a-year consultant to Robins and one of the original owners of Dalkon Corp.
A third study was by Dr. Mary O. Gabrielson, who reported a 1.9 percent pregnancy rate in the first half of an 18-month test. For the full period, the pregnancy rate was 5.1 percent. A report of Gabrielson's findings appeared in Family Planning Digest four months before the ad citing her lower figure.
The fourth study was by Dr. Donald R. Ostergard, an obstetrician/gynecologist at the University of California School of Medicine at Los Angeles. He reported a 1.1 percent pregnancy rate. Dr. Lester W. Preston Jr., Robins' scientific information chief, said of Ostergard's data in connection with another Robins-sponsored study that it "could well turn out to be a clear-cut case of GIGO" -- an acronym for "garbage in, garbage out."
A spokesman for Robins said each of the four studies was scientifically sound. He said Robins did not refer in the ad to the higher pregnancy rates that Gabrielson reported because they were only preliminary figures at the time. He said the information accompanying the Shield was updated as results of the various studies were made known.
Robins continued to use the 1.1 percent figure in its advertising well into 1973. On Oct. 31 of that year, Robins' official Allen J. Polon wrote in a memo entitled "Destruction of Dalkon Shield Literature": "A pregnancy rate of 1.1% is stated which is not valid . . . . Therefore please do not continue to use the two advertisements in question since both are outdated . . . . "
In February 1974 Robins received interim results of a company-sponsored study conducted at 10 clinics and hospitals. Those results showed pregnancy rates rising with longer use: after 12 months, 3.2 percent; after 23 months, 4.1 percent. In the final report of Robins' study, pregnancy rates after 24 months were as high as 7.2 percent.
IUDs generally had been the province of obstetrician/gynecologists, specialists trained in their use. In an August 1970 memo entitled "A Preliminary Market Study" -- written four months before Robins began selling the Shield -- Robins marketing people discussed just that subject: "GPs [general practitioners] and DOs [doctors of osteopathy] who do not routinely do pelvic examinations can constitute risky business. An IUD in the hands of a physician who is not familiar with reproductive anatomy is almost certain to have problems. Enough problems arise when competent physicians perform insertions. Under no circumstances should the Dalkon Shield be 'pushed' on a physician who is just casually familiar with pelvic anatomy. Such sales could be very detrimental to the establishment of this product."
Two months later, the company overcame its reluctance to promote the device to general practitioners. A company report cited the large number of such physicians who insert IUDs. It is unclear from internal documents whether the change of heart was based on the appeal of that large market or a conviction that it would be safe after all, or a blend of both. Dated Oct. 27, 1970, the report shows the company committing itself to a "total promotion" of the Shield: "Three physician groups will be targeted for intensive and continuing promotion: the obstetrician-gynecologist, the general practitioner/family physician, and the osteopath."
Many doctors had been reluctant to recommend IUDs for women who had not had children because of their susceptibility to medical problems and the risk of expulsion of the device. This was a largely untapped market that included millions of young women concerned about the safety of the birth control pill.
Hugh Davis and Robins thought they had a solution. Davis said that among the 640 women in his study were 51 younger women who had not had children, and that the device was well tolerated. His 1971 book told of "excellent results" in more than 300 such women at Hopkins. Davis had designed a smaller Shield for these women, and it had been sold even before Robins acquired the device. "The major change," Davis has said, "was simply to scale down the device . . . . "
Robins decided to sell the smaller Shield and promoted it with the low pregnancy rate Davis reported for the standard-sized Shield. Robins was enthusiastic with the experience reported by Davis and others, although at the time it did not have test results in hand on the smaller device. Davis finished a three-year small-Shield study in January 1972.
Robins knew of a study by Mary Gabrielson that questioned the Shield's suitability for young women who had not had children. Some 1,209 participants were fitted with smaller Shields. In April 1971, Gabrielson reported that 15 percent of those women had the Shield removed for medical reasons. A year later, she reported the "high rate of removal by then 26.4 percent " was due largely to "pain and/or bleeding."
A spokesman for Robins said Gabrielson earlier had reported favorable results with the smaller Shield. The Two-year Limit
The original owner of the Shield, Dalkon Corp., cautioned physicians: "At the end of two years, replacement with a fresh Dalkon Shield is recommended." Robins carried over the instruction into its initial labeling, but the advice bothered some Robins executives, who feared it put the Shield at a competitive disadvantage.
The Shield's leading rival did not urge replacement after two years, Robin's Shield project coordinator Kenneth E. Moore wrote in a November 1971 memo. "It was generally acknowledged that we probably are losing sales because of this." He advised dropping the recommendation. Many physicians, he emphasized later, had protested that they -- not Robins -- should choose the time for removal and replacement.
Moore told Freund and others in a memo that a plastics expert "indicated that we should be thinking in terms of establishing definite limitations . . . because historically it has been shown that nylon the composition of a three-inch tail string attached to the Shield does deteriorate in situ [in the body] over a period of time." In July 1972 -- three months after Moore wrote his memo -- Robins dropped the two-year limit and said it was a matter of "patient tolerance." On Sept. 12, 1972, Robins announced the change to its sales force.
NEXT: A search for answers