Women who had breast reconstruction surgery in European and Latin American countries using the PIP (Poly Implant Prostheses) silicone breast implant are urged to have the implant evaluated by a doctor.
The implants, made by a French company that's now out of business, carry the brand names PIP implant or M implant. The implants were taken off the market in 2010 when it was discovered that they had a very high rupture rate and were made with an industrial-grade silicone gel instead of the recommended surgical-grade gel. The implants were not marketed or used in the United States, but they were used in hundreds of thousands of women in Europe and in Latin America.
Health authorities in some European countries such as France, Germany, and the Netherlands have recommended that women with PIP implants have them removed to minimize any health risks, even if no problems are found by the doctor evaluating the implants. Some of the governments even have agreed to pay for the implant removal and reconstruction with a new implant. Other countries, such as Britain, Brazil, and Mexico, have recommended that the implant and breast be checked by a doctor and removal be considered if any specific problems are found.
About 75% of women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. There are many ways to reconstruct a breast. Tissue from the back, belly, or buttocks can be used to create a new breast. Saline or silicone gel implants are probably the most common choice. Saline and silicone gel implants are also used to improve breast size or appearance in healthy women.
In the late 1980s and early 1990s, doctors and women were concerned about possible links between certain health problems and silicone breast implants. Doctors thought the implants might increase the risk of inflammatory autoimmune diseases, such as arthritis and lupus, as well as breast cancer and other health problems. So since the late '80s, the U.S. Food and Drug Administration (FDA) has worked with implant manufacturers to monitor the experiences of women with silicone breast implants. In June 2011, the FDA released the results to date of the silicone implant monitoring program. The FDA found no evidence that silicone implants increase the risk of breast cancer or autoimmune diseases.
Still, in early 2011, the FDA reported a possible link between breast implants -- saline or silicone -- and a very rare form of lymphoma, called anaplastic large-cell lymphoma (ALCL), in tissue near the implant. Lymphoma is cancer in the lymphatic system. The FDA emphasized that it's not clear if this possible link exists and that even if it does, the risk of breast ALCL in women with breast implants is still extremely low. Currently available FDA-approved breast implants are safe when used as recommended by the manufacturer. The FDA advised "women with breast implants who are not showing any symptoms or problems, such as pain, lumps, swelling, or asymmetry, require only routine follow-up."
The PIP implants were a defective product and never approved by the FDA.
If you have a breast implant that was placed in the United States, the warning about PIP implants doesn't apply to you. But if you had breast reconstruction with a silicone implant outside of the United States, it's a good idea to talk to a doctor who can help you figure out if your implant is a PIP implant and can evaluate your implant's condition and the health of your breasts. It's good to know that the company that made these defective implants is now out of business. No matter what type of breast implant you have, never hesitate to call your doctor if you're concerned about the condition of your implant and the health of your breasts. Definitely call your doctor if you have symptoms or problems with your implant, such as pain, lumps, swelling, or asymmetry.
If you've been diagnosed with breast cancer and are considering reconstruction with an implant, you might want to ask your doctor about the FDA announcement on the possible link between implants and rare ALCL cancer. Still, know that the FDA doesn't think that this possible link should discourage women from implant reconstruction.
Visit the Breastcancer.org Reconstruction pages to learn more about breast implant surgery and other breast reconstruction options.