Breast Implants Facts : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 3)

In January 2004 — contrary to the recommendation of the agency's advisory panel — the FDA determined that the new silicone gel-filled breast implant PMA was "not approvable" at that time. This meant that the implants were not approved for marketing pending additional information, but that women would continue to have limited access to them by enrolling in clinical studies.

"The public scientific process that has been used to consider these devices is fully consistent with the FDA's mission — to use the best available science to protect and promote the public health interests of the American people," says Linda Kahan, deputy director of the FDA's Center for Devices and Radiological Health (CDRH).

Also in January 2004, the agency released a draft of its new guidelines for companies submitting breast implant PMAs, explaining the scientific issues that the FDA recommends be addressed as part of their applications. The guidance document reflects the FDA's current thinking about new scientific information that the agency, manufacturers, and the clinical community have gained over the last 10 years, including information learned at the October 2003 advisory panel meeting. Consistent with the FDA's good guidance practices, the agency has asked for public comments on the breast implant guidance. The guidance is not intended for implementation until it is finalized.

"Current testing doesn't reflect reality," says Michael A. Choti, M.D., an associate professor of surgery and oncology at the Johns Hopkins University School of Medicine in Baltimore, and also an FDA advisory panel member. The implants, he says, are extremely durable when tested outside the body. "You can virtually run a truck over them and they'll hold up. But the question is, what happens when implanted long-term in a woman's body?"

The FDA's draft guidance document says that two to three years of follow-up data may not be enough to allow the agency to evaluate the safety and effectiveness of breast implants. The agency recommends the use of tests that can predict clinical outcomes, such as how long breast implants will last before rupturing in the body, as well as tests that explain how and why the breast implants rupture. In addition, the agency recommends that more data be gathered regarding the rate of rupture over time, as well as the health consequences of rupture.

Breast Implant Risks

In 1999, the Institute of Medicine (IOM) issued a report on a review of information related to health effects associated with silicone breast implants, both gel-filled and saline-filled, in humans. An important goal of the IOM was to provide women with detailed information about the potential risks of silicone breast implants.

One risk is capsular contracture, which is a tightening and squeezing of the scar tissue that naturally forms around the implant. This contracture may result in hardening of the breast tissue, rippling of the skin, and changes in breast shape. It also may cause pain, which, if severe, can require surgery to remove the scar tissue or replace the implant.

In addition, a rupture can occur at any time. While saline-filled breast implants leak only salt water when they rupture, the health effects of leaking silicone gel-filled implants remain controversial. Women sense a change more easily when saline-filled breast implants rupture. But the silicone gel-filled implants are more likely to maintain their shape after they rupture, which can make it more difficult to detect a break.

Called "silent ruptures," these breaks involving silicone gel implants may occur without a visible change. And a woman may not feel any sensation, says Sahar M. Dawisha, M.D., a medical officer in CDRH who has reviewed data submitted by implant manufacturers. Magnetic resonance imaging (MRI) with equipment specifically designed for imaging the breast may be used for evaluating women with suspected rupture of their silicone gel-filled implant. The FDA considers MRI to be the best method at this time. There are no standards on how often to screen for silent rupture with MRI, and the costs of this procedure must be considered when choosing a silicone gel-filled breast implant. Physicians usually recommend removal of the implant if it has ruptured, regardless of whether it is saline-filled or silicone gel-filled.

Another potential complication of implant surgery is nerve damage, which can cause some women to experience a loss or increase in sensation in their nipples and breast tissue. These symptoms may disappear eventually, but can be permanent in some cases. It is unclear at this time whether insufficient milk production to breast-feed — another reported problem — is due to damaged nerves or to other reasons.

Women should know that, regardless of the type of implant, it is likely they will need to have one or more additional surgeries (reoperations) over the course of their lives, because of complications from breast implants. Reasons for reoperations include any of the potential complications, such as capsular contracture, wrinkling, asymmetry, rupture, or implant malposition.

The IOM committee also found that women with silicone breast implants are no more likely than women without implants to develop the life-threatening systemic illnesses that some people have claimed might be related to the implants.

But many women disagree. They have reported health problems related to their immune systems or neurological symptoms that they believe are caused by ruptured or intact breast implants. And some women who have received breast implants claim they weren't fully informed of the risks.

Lynda Roth, who was diagnosed with breast cancer in 1990, says she was forced to make a quick decision, based on very little information, about getting breast implants following a mastectomy.

"I trusted what my highly respected doctors were telling me was true," says the 63-year-old social worker in central Colorado. "You're in shock, you think you're going to die, so what kind of informed decision can you possibly make about what you want your breasts to look like if you're lucky enough to survive?"

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.