U.S. officials urged to set up mandatory breast implant patients registry

In the latest world wide breast implant crisis, American health officials were urged to set up efficent mandatory registry to track breast implant patients, according to media reports Friday. "If we had had registries, we would have known years ago if it's true that PIP implants break sooner," admitted Diana Zuckerman, president of the U.S. National Research Center for Women & Families. "We would have known if Mentor ones break sooner or later than Allergan's," she added, referring to the two largest makers of breast implants. In U.S., patients could report problems with implants to the FDA's MedWatch program, a system for tracking of complaints about drugs and devices, which the agency can theoretically use to detect problems. But many people are not aware it exists, and the majority of patient who testified on problems with breast implants did not report the issue to MedWatch. Beside, manufacturers and medical facilities such as hospitals are required to notify the agency of device-related deaths. But reports of serious injuries from devices will only inform the manufacturer, who then decides what to report to the FDA within a 30-day period. Given those drawbacks, Dr. Caroline Glicksman, a New Jersey-based surgeon, suggested the registry should be mandatory. "A registry is valuable. When an implant deflates or things go wrong, it's very important to have because these are not life-long devices," Glicksman said. The crisis was produced by the French company Poly Implant Prothese (PIP), once the world's third-largest producer of silicone implants that sold its faulty products to tens of thousands of women in more than 65 countries, mainly in South America and Western Europe. The French government has already urged 30,000 women to remove the local-made breast implant, pledging that relevant expenses would be covered by the state. And governments in several countries, such as Britain and Brazil, have asked women to visit their doctors for checks. In Venezuela, the government even offered women having faulty French-made breast implants free remove surgeries. It been considered that an efficient mandatory registry would help the authorities to know the number of complications over time, such as rupture or infection. However, so far, there is no continent-wide registry and efficient tracking system in U.S. and Europe.