FDA, new study dismiss link between breast implants and connective-tissue diseases.

Citing a string of medical studies showing no link between breast implants and certain connective-tissue diseases, FDA Commissioner David Kessler recently told a congressional subcommittee that there is "reasonable assurance" that implants do not cause "traditional connective-tissue disease."

In testimony before the Government Oversight and Reform Subcommittees on Human Resources and National Economic Growth, Kessler said that implants have not caused a significant increase in the incidence of diseases like rheumatoid arthritis and scleroderma. But he added that there was insufficient information to rule out a connection between implants and other atypical illnesses. (John Schwartz, Silicone Implants' Link to Disease Is Played Down, Wash. Post, Aug. 2, 1995, at A17.)

Kessler's comments came only weeks after the publication of a major study showing no clear link between silicone gel implants and connective-tissue diseases. (J. Sanchez-Guerrero et al., Silicone Breast Implants and the Risk of Connective-Tissue Diseases and Symptoms, 332 New Eng. J. Med. 1666 (June 22, 1995).)

Breast implant manufacturers and some doctors claim the study should end the debate over whether implants cause connective-tissue illnesses like rheumatoid arthritis, lupus, and scleroderma. But critics of the work say its research was flawed because it focused on a sample that is too small to be statistically significant and ignored the signs and symptoms of the atypical diseases that breast implant recipients frequently suffer from.

The study - conducted by researchers at Harvard Medical School, Brigham and Women's Hospital, and the Harvard School of Public Health, all in Boston - looked at medical records of 87,501 nurses who agreed in 1976 to take part in long-term research into factors that affect women's health. Researchers analyzed data collected from the women before June 1, 1990, about six months after reports of a link between breast implants and a variety of illnesses began to receive national attention.

Only 1,183 of the nurses had received breast implants during the 14-year period examined. Of those, 876 had implants made from silicone gel. Researchers discovered that only 3 of the 516 women who had been diagnosed as having connective-tissue diseases also had breast implants. Just 1 had silicone gel implants.

The researchers also reviewed the medical histories of 5,087 of the nurses who had merely reported signs or symptoms of connective-tissue diseases. Of these, 32 had breast implants and 21 had silicone gel-filled implants.

The study's authors said they found no "association between silicone breast implants and connective-tissue diseases ... or signs and symptoms of these diseases," including arthritis, photosensitivity, morning stiffness, and dry eyes. "The incidence of connective-tissue diseases was within the range previously reported in population-based studies," the authors noted.

The findings are consistent with several earlier studies on the health effects of implants. But critics of the researchers' methods say the findings are not representative of all women who have received silicone implants. "It is far from conclusive on the issue of whether silicone breast implants are linked to classical autoimmune disease," said Michael Hugo, a Boston attorney and cochair of ATLA's Breast Implant Litigation Group.

Hugo said that the sample size of the study was "way too small" and that the researchers "were looking for the wrong diseases." Of the 70,000 women who have implant-related problems, Hugo noted, "all have atypical diseases not seen in the general population and not looked for in this study. A good analogy would be where the makers of above-ground pools do a study to determine at what rate people are hit by trains while swimming in their pools."

The research also was criticized for including women who had had their implants for only 30 days. "This would be like including people who had smoked for a month in a lung cancer study. The industry's own documents state that the symptoms that the women are complaining of typically appear 6 to 10 years after implantation," Hugo said.

The researchers acknowledged that they "could not study subjective and largely unverifiable symptoms, such as fatigue, decreased ability to sleep, frequent sore throats, cognitive deficits, arthralgias, lymphadenopathy, or dizziness, or diseases such as fibromyalgia." Yet these are the symptoms and illnesses that many breast implant recipients say they suffer from. Doctors who have treated women with breast implant problems argue that any study that fads to take these medical conditions into account cannot be relied on to prove implants do not cause connective-tissue diseases.

It is unclear how Kessler's comments or the study will affect breast implant litigation. In late April, the judge overseeing a $4.2 million class-action settlement between 410,000 implant recipients and several manufacturers concluded it was insufficient to pay immediate claims and ordered attorneys on both sides to return to the negotiating table. Since then, Dow Corning Corp., the largest contributor to the settlement fund, declared bankruptcy.

Hugo said attempts by industry lawyers to use the study as a bargaining chip during the class-action settlement negotiations have been unsuccessful. The manufacturers are "trying to raise [the study] as a club over the heads of the plaintiffs' settlement attorneys, but plaintiffs just aren't listening to them," Hugo said.