Dear NATRELLE® Visitor,
As you may know, today, January 26, 2011, the U.S. Food and Drug Administration posted an online announcement about the rare occurrence of anaplastic large cell lymphoma (ALCL), which is a rare subtype of lymphoma, in women both with and without breast implants. This announcement drove many articles in the media that may have caught your attention and likely raised some questions that we would like to help address.
As the makers of the NATRELLE® breast implant collection, patient safety is Allergan’s absolute first priority. So we want to ensure you have all the facts you need about important safety information such as this to feel reassured about the choice you have made or are about to make, or to have an informed discussion with your physician.
As the FDA stated in its online communication, FDA-approved breast implants, when used as labeled, are safe and effective. Breast implants are among the most studied medical devices in existence, with thousands of peer-reviewed and published reports on studies, including robust epidemiological studies supporting their safe use. The safety of Allergan’s NATRELLE® breast implants is supported by Allergan’s extensive pre-clinical device testing, and the use of breast implants in millions of women worldwide over the past 25 years.
Over the past 15 years, there have been very rare, sporadic reports of ALCL, occurring in women both with and without breast implants. These reports of ALCL in patients with breast implants are extremely rare and are not to be mistaken for breast cancer. Also, several studies have shown that the overall rate of lymphoma is no greater in patients with breast implants than in the general population.
Of the estimated 5 to 10 million women who have breast implants worldwide, only 34 cases of ALCL have been identified and reported in peer-reviewed literature over nearly 15 years, since 1997. These rare cases of ALCL have predominantly appeared in the scar tissue that forms around the implant. Importantly, when occurred, most of those few patients with ALCL have responded positively to a variety of treatments, including simple removal of the implant and of the surrounding scar capsule.
Based on available information, there is no data to support that breast implants cause the condition of ALCL. The data does indicate that the incidence of ALCL is very low, even in breast implant patients. In those sporadic reports of ALCL in breast implant patients, the origin or cause is unknown. Furthermore, it is not possible to identify a type of implant (silicone versus saline) or a reason for implant (reconstruction versus aesthetic augmentation) associated with a smaller or greater risk for this very rare occurrence of ALCL, as the rarely reported cases have involved textured and smooth surfaced, and both saline and silicone filled implants.
While there have only been a few reports of ALCL in breast implant patients over the past 15 years, Allergan has been in ongoing dialogue with the FDA and all other regulatory authorities around the world about these rarely reported cases. The company also sponsored a scientific advisory committee to independently evaluate reports of suspected ALCL in patients with breast implants and carefully assess and review each case. In addition, Allergan has provided ongoing communication to the medical community regarding these rare reports of ALCL in breast implants and created an online scientific web site for health care providers’ access, summarizing all published public literature on the subject of ALCL, so physicians can have the most informed discussion with you.
If you are a women who has received breast implants and do not currently experience any issues but are concerned about the potential occurrence of ALCL, we do not recommend you alter your routine medical care, but continue to undergo routine mammography screenings and speak with your physician if you suspect any abnormality.
Again, we want to reassure you that patient safety is Allergan’s absolute first priority and we continue all efforts to collect and analyze further information about the very rare occurrence of ALCL in patients with breast implants. We are in ongoing dialogue with the FDA to evaluate the best course of action for health care providers and patients and adjust these recommendations as needed.
We are also deeply committed to providing important, up-to-date information about the safety and efficacy of our products to physicians and patients so you can make the most informed treatment decisions.
Complete safety information about NATRELLE® breast implants can be found here at www.natrelle.com. Should you have any further questions about this matter or would like to speak to an Allergan representative, please contact our Product Support Department at 1-800-624-4261. We’d be happy to provide any additional information you may need.
To access the important information posted by the FDA on the very rare incidence of ALCL in breast implants, please visit: http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm240000.htm