FDA Rules on Saline Filled Breast Implants

Jun 2000
Food & Drug Administration

As expected, on May 10 the Food and Drug Administration (FDA) ruled that saline-filled breast implants made by both Mentor Corporation and McGhan Medical Corporation may continue to be marketed and that information on the risks should be made available to women so they can make informed decisions. In addition, the saline breast implants were approved for breast augmentation in women 18 years or older and for breast reconstruction.

Condition for Approval: Patient Education Brochures As a condition for FDA approval, McGhan and Mentor have each prepared an educational brochure with input and approval by the FDA These educational brochures are designed to assist women in making an informed decision about breast augmentation and breast reconstruction and in talking with their doctor.

Each company's brochure provides information on indications for surgery, factors to Consider, contraindications and precautions, types of implants, photos of implants, descriptions and drawings of breast anatomy and implant placement, and discussion and data tables on complications and risks, The intent is that physicians performing implant surgery will provide the brochure to women considering saline breast implants. Both Mentor and McGhan's documents are available on the FDA's web site and may be downloaded in pdf or text format. (http://www.fda.gov/cdrh/whatsnew) Key information to women taken from companies’ brochures: While the specific language varies between the two brochures, the Intent is the same and is summarized below: Breast implants are contraindicated for women with:

• Existing malignant or pre-malignant cancer without adequate treatment
• Active infection anywhere in the body
• Augmentation in women who are currently pregnant or nursing

Surgical practices that are contraindicated in breast implantation:

• Any contact of the implant with Betadine
• Injection through implant shell
• Alteration of the Implant
• Stacking of implants: more than one implant per breast per breast pocket

Important factors for women to consider:

• Breast implantation may not be a one-time surgery.
• Breast Implants are not considered lifetime devices. You will likely undergo Implant removal with or without replacement over the course of your life.
• Many of the changes to your breast following implantation are irreversible (cannot be undone). If you later choose to have your implant(s) removed, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast.
• Breast implants may affect your ability to produce milk for breast-feeding. Also, breast implants will not prevent your breast from sagging after pregnancy.
• Routine screening mammography will be more difficult, and you will need to have additional views, which means more time and radiation.
• For patients who have undergone breast implantation either as a cosmetic or a reconstructive procedure, health insurance premiums may increase, coverage may be dropped, and/or future coverage may be denied. Treatment of complications may not be covered as well. You should check with your insurance company regarding these coverage issues.

Safety and effectiveness has not been established in patients with the following conditions:

• Autoimmune diseases such as lupus and scleroderma
• Conditions that interfere with wound healing and blood clotting
• A weakened immune system (e.g., currently receiving immunosuppressive therapy)

Further considerations for women, from the companies' brochures: Pre-implantation Mammography - You may wish to undergo a preoperative mammogram and another one 6 months to one year after implantation to establish a base-line. Interference with Mammography - The implant may interfere with finding breast, cancer during mammography and also may make it difficult to perform mammography. Therefore, it is essential that you tell your mammography technologist that you have an implant before the procedure. The technologist can use special techniques to minimize the possibility of rupture and to get the best possible views of the breast tissue. Because the breast is squeezed during mammography, it is possible fur an implant to rupture during the procedure. More x- ray views are necessary with these special techniques; therefore, women with breast implants will receive mo; V radiation. However, the benefit of the mammogram in finding cancer outweighs the risk of the additional x-rays. Distinguishing the implant from breast tissue during breast self-examination – You should perform breast self-examination monthly on your implanted breast In order to do this effectively, you should ask your surgeon to help you distinguish the implant from your breast tissue. Any new lumps or suspicious lesions (sores) should be evaluated with a biopsy. If a biopsy is performed, care must be taken to avoid puncturing the, implant. Long-Term Effects - The long-term safety and effective- ness of breast implants have not been studied. However, additional testing is in progress to examine the long-term (i.e., 10 year) chance of implant rupture, reoperation, implant removal, and capsular contracture (hardening of the tissues around the implant), Mechanical testing is also being conducted to assess the long-term likelihood of implant rupture. Capsule Procedures - You should be aware that closed capsulotomy, the practice of forcible squeezing or pressing on the fibrous capsule around the implant to break the sear capsule is not recommended as this may result in breakage of the implant. Identification Cards - Women who receive saline-filled breast implants will be given a device identification card with the style and serial number of their breast implant(s).