WASHINGTON -- Two companies are seeking an end to the nation's decade-plus ban on most silicone-gel breast implants despite lingering questions about how long the devices will last inside a woman's body and what health risks could result if they break, government documents released Wednesday suggest.
The Food and Drug Administration will consider the issue next week in a three-day meeting with its scientific advisers. The meeting is an important hurdle in determining whether the implants can re-enter the U.S. market.
Since 1992, they have been available only to women enrolled in strictly controlled research studies, because of fears they could cause major health problems.
The implants largely have been exonerated of causing such serious or chronic illnesses as cancer or lupus. But painful scar tissue that can form around the implants, breaks that require surgery to remove or replace implants, and other complications remain a source of contention.
Just 15 months ago, the FDA told manufacturers that it would not lift restrictions on the implants' sale until questions about breakage, in particular, were settled.
Competitors Inamed Corp. and Mentor Corp., both of Santa Barbara, Calif., believe they have met that requirement. The companies contend that breast implants, like pacemakers or metal hips, do not last forever, but that newer generations are acceptably durable.
Those are better than salt water-filled implants that U.S. women can buy today, said Dan Cohen, vice president at Inamed.
Because broken implants do not always cause immediate symptoms, the FDA asked manufacturers to use MRI scans to track the implants' durability.
Mentor cited one study suggesting three-year breakage rates that ranged from less than 1 percent to 5 percent of patients.
Inamed's data showed that over four years, implants ruptured in 3.4 percent of women who had received them for breast enlargement patients and in 20.5 percent of breast cancer patients who received implants after a mastectomy. The company attributed that higher rate to a particular implant model that is being redesigned.
But those studies tracked small numbers of women for a short time, FDA scientists cautioned in preliminary analyses posted on the agency's Web site Wednesday.
"These data are of limited value" in determining how many years a woman can expect her implant to last - and what pain or other complications she might experience when it breaks and the silicone gel inside oozes out, one FDA document concludes.
In a second document, FDA scientists estimated that up to three-quarters of the devices might rupture within 10 years of implantation, requiring women to have additional surgery to remove or replace the implants.
Other documents suggest that if the FDA approved widespread sales of implants, recipients would be encouraged to get regular MRI exams, perhaps every year or two, to check for breakage. Those exams cost hundreds of dollars, and there is no way to ensure women would get them, said Diana Zuckerman of the National Research Center for Women and Families.
For the second time in less than two years, the FDA is debating the silicone-gel implants. In October 2003, its advisers narrowly recommended allowing the implants to be sold again; the agency overruled the recommendation.
Debate at the meeting next week will pit patients who say the implants caused lasting scars against others who say the silicone-gel versions look and feel more natural than saline implants.
The FDA on Monday will hear from the public.
"I'm 23 years old and I'm in bed most days almost all day," says Shannon Scott of Lakeside, Calif., who developed severely painful scar tissue a year after receiving her 2002 breast implants.
Uninsured and on disability, she says she cannot afford to have them removed - and will tell the FDA committee that her surgeon never reported her complaints so that researchers could properly count side effects in implant studies.
Kerri Branson of North Aurora, Ill., who first received silicone-gel implants in 1990, was so pleased that she got a second set last summer to firm up breasts sagging from breast-feeding the four children she had in the interim.
"I've never ever regretted my choice," said Branson. "I wish that other women could feel as great as I do."
