Plastic surgeons' society tells what it knows about saline implants

 


Title: Plastic surgeons' society tells what it knows about saline implants. (American Society of Plastic and Reconstructive Surgeons) (U.S. Food and Drug Administration) Citation: Cancer Weekly, April 19, 1993 p8(2)


Subjects: Breast implants_Health aspects


Full Text COPYRIGHT Charles Henderson, Publisher 1993

U.S. FDA

The American Society of Plastic and Reconstructive Surgeons (ASPRS) submitted information to the U.S. Food and Drug Administration (FDA) in accordance with a deadline to present comments on saline-filled breast implants.

The information includes the following:

* Safety questions on saline-filled breast implants revolve primarily around the implant's silicone shell and valve, since the implant is filled with a sterile saltwater solution that is harmlessly absorbed by the body if a rupture occurs.

* The silicone shell of the saline implants parallels the material that makes up other medical devices, such as cardiac pacemakers, intravascular catheters, and hydrocephalus shunts. Large numbers of such implantable devices have been and are currently in place without complaints of adverse immunological effects.

* The question of whether prolonged contact with the breast implant's silicone shell could produce a risk of immunological disorder awaits resolution. Current epidemiological studies are under way to examine this relationship with silicone gel-filled implants.

* Because of a newer, "textured" design in implants' silicone shells, the incidence of capsular contracture (hardening of the breast as scar tissue contracts around the implant) is expected to decrease with patients who are implanted with the textured design.

* Data indicate that deflation rates for saline implants are low, especially as the design of implants has improved over the years. Today, the deflation rate amounts to about 1 percent to 2 percent over a 5- to 10 -year time span. More studies on deflation rates are needed that would include an analysis of valve design.

* Well-controlled studies are awaited from radiologists to define the effect of the silicone shell on visualization of breast tissue. Currently, a radiologist trained in particular techniques specifically for patients with breast implants is able to view a large portion of breast tissue to detect early breast cancer.

* Existing studies of breast implants are encouraging and suggest safety and efficacy. The ASPRS agrees that epidemiologic studies, well-designed to eliminate bias, will produce the best data on saline breast implants.

The ASPRS' role in providing this information to the FDA is advisory, acting as advocate for plastic surgery patients to make sure that the FDA looks for data that will help patients make informed decisions. The FDA's review process is designed to collect scientific data from sound scientific studies and does not provide for clinical reports.

The FDA's call for information on saline breast implants continues the process by which the FDA is reviewing all medical devices for government classification and public availability. The FDA was given the power to regulate all medical devices in 1976.

Saline-filled breast implants are currently the only alternative for women who seek breast augmentation for aesthetic reasons. Saline-filled breast implants are also available for reconstructive purposes. Silicone gel-filled implants are available only under strict guidelines for women who need breast reconstruction after mastectomy, to correct a congenital deformity or for other reconstructive reasons.


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