Breast Implant Registry
Robert E. Frank, M.D.
The need for basic breast implant information has never been more important. Patients and surgeons alike are handicapped when patients do not know the type, placement and volume of their implants. This information, while initially available to patient, surgeon and surgery center, is often lost as the statute of limitation for retaining medical records expires and physicians and surgery centers dispose of patient charts. In some states, medical records are retained for as little as two years following surgery.
Patients are often left as the sole trustees of this data, often without realizing its importance. FDA statistics demonstrate that a third of patients will have their implants replaced within the first ten years following surgery.
In October 2003 the United States Food and Drug Administration mandated a registry of breast implants as part of their review of the safety of silicone gel implants. The PSEF established a registry of breast implants in 2001 but to date only 16,093 patients have been enrolled. This represents less than 3% of all patients having the procedure since the registry’s inception. The most significant limitation for this registry is the fact that it relies on individual surgeons to enroll their patients. Surgeons are reluctant to participate and incur the additional paperwork burden brought on by registering their patients.
We present a new internet-based breast implant registry (www.breastimplantregistry.com) in which patients register themselves. The registry is HIPAA compliant and all patient data is encrypted. Patients select passwords known only by them. For a twenty-five dollar membership fee, data is kept for ten years. Patients are contacted annually to update their information and are prompted to renew their membership as the ten year term ends.
Besides the obvious advantage of allowing patients to maintain their breast implant information, we hope to implement several additional benefits. We hope to be able to contact patients to remind them to schedule their annual mammograms. We plan to notify patients by email when their implant warranty is due to expire. We also hope to be able to contact patients if there are recalls which might pertain to them and their implants.
In a more global sense, access to these patients through email will allow researchers to get more accurate numbers of patients experiencing deflation, capsular contracture and displacement. The registry is not affiliated with any implant manufacturer or with any formal plastic surgery organization. Through this unbiased stance we hope we can provide quality information to both board certified plastic surgeons and cosmetic surgeons alike. Hopefully, through widespread participation in this new registry, accurate data can be provided to the FDA, surgeons and their patients alike.
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