Attorneys challenge findings in Mayo breast implant study.

Consumer advocates and lawyers for women who say they were injured by silicone-gel breast implants are raising concerns about the conclusions and the timing of a recent study that found no association between the devices and various connective tissue diseases and other disorders.

Many epidemiologists and officials at the U.S. Food and Drug Administration welcomed the study as one of the first pieces of scientific evidence about implant risks. But critics say the study did not review enough cases over enough years to be conclusive.

Lawyers representing women in litigation against implant manufacturers also charged in a statement that the study's June 16 publication in the New England Journal of Medicine was "a clear attempt to scare women with breast implants into opting in" to the $4.2 billion global implant settlement. Women had until June 17 to decide whether to settle with the class or to pursue their cases individually at trial.

The statement, issued by the National Plaintiffs' Steering Committee in the breast implant multidistrict litigation, also questioned the objectivity of the study. The lawyers cited documents produced in litigation that they said show funding for the study came from major implant manufacturers, including Dow Corning Corp. and Bristol-Myers Squibb Co.

The study also lists the Plastic Surgery Educational Foundation as a source of funding. The lawyers' statement said the manufacturers contributed money to the foundation, which then made payments to the researchers.

Dr. Jerome Kassirer, editor-in-chief of the New England Journal of Medicine, said "it was a complete surprise to us" that the opt-out deadline was the day after the study was published. He said the article had gone through the usual prepublication process over the roughly eight months between the time the article was submitted to the journal and the time it was published. He added that the journal's editors had had no contact with breast implant manufacturers regarding the study.

The study's authors--doctors at the Mayo Clinic in Rochester, Minnesota--said their research showed "no association between breast implants and the connective-tissue diseases and other disorders that were studied." (Sherine E. Gabriel et al., Risk of Connective-Tissue Diseases and Other Disorders After Breast Implantation, 330 New Eng. J. Med. 1697 (1994).)

The researchers reviewed the medical histories of more than 2,200 women who had been treated at the Mayo Clinic between 1964 and 1991. The population included 749 women who had received at least one breast implant during that time and 1,498 women (the control group) who had not received implants.

The doctors found that a connective tissue disease had been diagnosed in 5 women with implants and 10 women in the control group. Symptoms of arthritis were found in 25 women with implants and 39 women in the control group. "Only morning stiffness was significantly increased among the women who had received a breast implant," the study found, but the authors said this symptom was likely caused by the patients' underlying breast cancer.

The lawyers' statement faults the study for not following enough women over a long enough period and for looking only for classic symptoms of a few well-defined diseases. "In many instances, the signs and symptoms in women with silicone-induced diseases present atypically so that the women do not meet the classic diagnostic disease criteria," the statement said.

Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, wrote in a letter to the New York Times that the researchers "might better have concluded that because of the limited size of the study, the negative findings should not be taken as an assurance that breast implants are not causing connective tissue diseases." (Sidney M. Wolfe & Joanne C. Mott, Implant Study Too Small for Final Word, N.Y. Times, June 28, 1994, at A16.)