Silicone safety helps women's providers

Tuesday, September 30, 2003

WASHINGTON - Although a battle has erupted over an FDA review of the ban on silicone gel breast implants, officials in the women’s health industry do not expect the debate to affect business.

If anything, Victoria Jones, owner of the Texas-based Women’s Health Boutique, thinks the ban has raised awareness of the risks associated with breast augmentation, resulting in more women choosing post-mastectomy breast forms over a surgical procedure.

“I don’t think lifting the ban [on silicone implants] will have much of an impact on the post mastectomy side of reconstruction,” said Jones. “I think women are still afraid of them. I think that if companies come back now and say ‘well we decided it’s safe’ that women are not going to believe them.”

The Santa Barbara-based manufacturer Inamed appears to disagree.

Inamed officials say silicone implants dominate the market by 85-90% where both silicone and saline are available. For this reason, the company applied for pre-market approval from the FDA to begin manufacturing silicone gel-filled implants.

Inamed is one of two U.S. companies that still manufactures saline implants.

“We think there is a growing body of evidence that supports silicone implants,” Peter Nicholson, Inamed’s vice president of business development, told The Los Angeles Business Journal.

Inamed also has pointed to a long-term study of breast cancer patients that has failed to detect significant increases in death and cancer among patients.

The National Organization for Women also has gotten in to the fray, condemning what it sees as faulty research.
NOW held a conference in May where many researchers and clinicians agreed the long-term safety of the implants has not been adequately addressed, according to Kim Gandy, president of NOW.

“Breast implants are being treated by some at the FDA as a cosmetic device and not as a medical device,” Gandy said. “They are treating it more like lipstick than a pacemaker. The reality is that this is something used for cosmetic purposes that might cause a medical problem. Then it becomes effectively a medical device and should be investigate as thoroughly as a pacemaker.

However, the feeling of many women is that those who want breast implants are unlikely to be swayed by the safety concerns.

Victoria Ellis, a mastectomy fitter and four-year breast cancer survivor got implants after having a bilateral mastectomy. Ellis described her decision as something she needed to do for herself.

“It was not enough for me to just be alive after my battle with breast cancer, I wanted the look of good health too,” said Ellis.

“Each of us know, as women, what we need in order to live normal lives and feel good when we look in the mirror at ourselves,” she added.