FDA says breast implants safe, but consumer groups want more

Kathleen Blanchard's picture
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The FDA has ruled there is no evidence suggesting silicone breast implants should be removed from the market, though they can rupture and cause hardening of breast tissue. Consumer groups want more information and say more studies are needed.

Though the FDA assures women their implants are safe, 79% of women enrolled in studies about their safety have been “lost’ for follow-up.

Silicone implants were removed from the market in 1992 after some women became chronically ill, but in 2006 the FDA re-approved their use on the condition that research continues about their safety.

One of the concerns is that silicone might lead to connective disease disorders, rheumatoid arthritis, difficulty interpreting mammograms and even fertility issues.

Several companies lost women enrolled in studies three years after enrollment, including Mentor, the maker of Memory Gel implants, who lost 79% of the women enrolled and Allergan, the maker of Natrelle implants, who lost almost 40% of participants two years after study enrollment.

Consumer groups finds data on breast implant safety unacceptable

Consumer groups feel it’s unacceptable that women aren’t being followed. Manufacturers’ of breast implants say they may have “over reached” in trying to follow so many patients, stated by representatives during the recent FDA advisory committee meeting, which took place on Tuesday.

Jan Erickson, of the National Organization for Women Foundation says, "It's unacceptable that many patients Mentor and Allergan were supposed to track were lost.” Women in the studies were asked to fill out a 27 page questionnaire each year.

According to NOW:

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“There remains a continuing need to conduct clinical and laboratory studies on the immunological and toxicological effects of silicone gel on human physiology. We need properly designed studies that measure the effect of the chemical constituents of silicone gel in pregnant women and on their developing fetuses. We need information about the transmission of potentially harmful chemicals to breastfeeding infants. Clinical trials should follow children born to mothers with silicone gel-filled breast implants to evaluate any health or developmental problems.”

Dr. John Canady, medical director at Mentor, was asked if the company's study had any design flaws.

His response was, “In retrospect, it's perhaps not surprising that if a patient or surgeon enrolls because they are required to, and then a patient is told because of voluntary consent they're not ... that might contribute to low follow-up rates."

The company originally told women they would provide breast implants strictly on the condition that they would enroll a study, but then later changed participation to voluntary.

NOW says there are reporting flaws in data already collected about silicone breast implants, citing rupture rates as being reported per implant versus per patient, which “understates” the occurrence.

The group believes Mentor should not be marketing silicone breast implants, Allergan should be required to improve and continue studies with FDA oversight while a “moratorium” is placed on marketing and right rescinded if that doesn’t happen in two years.

The National Research Center for Women & Families contends there are too many unanswered questions, mostly due to study design that relies on patient information versus patient examinations and medical records.

The group recommends that women should save money for surgery to remove problem breast implants. Advice to women from the FDA is: “Assume that you will need to have additional surgeries.”

Dr. William Maisel, chief scientist for the Food and Drug Administration’s Center for Devices said, “Women should feel assured that the FDA continues to believe that currently marketed silicone breast implants are safe", but consumer groups want more safety data.

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