Washington — A breast implant scandal in France has rekindled a push to create a U.S national registry to track patients who have received the devices, Reuters reports.
A registry would provide information on the number of implant complications — such as rupture or infection — that occur over time.
The scandal involved French company Poly Implant Prothese (PIP), which used industrial grade instead of medical grade silicone to make implants that were surgically placed in some 300,000 women worldwide. The French government has advised the 30,000 women in France who received the implants to have them removed, while governments in several other countries — the U.K. and Brazil among them — have issued advisories that women visit their doctors for checks.
Reuters quotes Diana Zuckerman, president of the National Research Center for Women & Families, as saying, “If we had had registries, we would have known years ago if it’s true that PIP implants break sooner. We would have known if Mentor ones break sooner or later than Allergan’s,” she added, referring to the two largest makers of the devices.
Since allowing silicone implants back on the market in 2006 after banning them 14 years earlier, the Food and Drug Administration has relied on company-funded efforts to track implant safety. The agency’s approval for Allergan and Johnson & Johnson’s Mentor unit to again market silicone implants in the United States was conditional on the companies each following 40,000 women who received the implants for 10 years, as well as extending smaller preapproval studies.
As of August, Allergan said it had only collected two-year data for 60 percent of participants, while Mentor only had three-year data for 21 percent, Reuters reports.
Consumer and patient groups have criticized the two companies for failing to meet the goals and have asked the FDA to revoke Mentor’s marketing approval and to force Allergan to conduct further studies.
Mentor and Allergan both expressed support for a registry at an FDA meeting in August. But the companies, physicians and regulators have so far failed to reach an agreement over who would pay for the registry, how information would remain private and whether participation would be mandatory.
Reuters reports that so far, the companies’ studies have found similar rates of complications such as rupture and hardening of the devices, and no apparent link between silicone implants and connective tissue disease, breast cancer or reproductive problems. The FDA says the low level of patient participation renders these findings inconclusive.
Go back to the Cosmetic Surgery Times eNews newsletter.