Regulatory Focus™ > News Articles > Reuters Analysis: Breast Implant Scandal Shows Shortfalls of Post-marketing Registries

Reuters Analysis: Breast Implant Scandal Shows Shortfalls of Post-marketing Registries

Posted 02 January 2012 | By Alexander Gaffney, RAC 

The Poly Implant Prothese (PIP) scandal raging across Europe right now highlights the failings of regulatory agencies to effectively use post-marketing registries, claims Reuters journalist Anna Yukhananov. A registry, Yukhananov argues, would have allowed regulatory authorities around the world to identify patterns of implant failures and risks associated with the products.

To date, no unified registry of breast implants exists in the United States, and US Food and Drug Administration (FDA) efforts to track the devices via post-marketing obligations for manufacturers have failed to meet the agreed-upon numbers. Approvals for breast-implant manufacturers Allergan and Johnson & Johnson (J&J) were conditional upon the companies keeping track of 40,000 women who were recipients of the medical devices for a decade after their initial surgery.

Both companies were unable to meet those obligations, and now some consumer groups are clamoring for the FDA to revoke their respective marketing approvals and force both to conduct follow-up studies.

The FDA's deputy director of the Center for Devices and Radiological Health (CDRH), Dr. William Maisel, is defending the agency, claiming that the problems are with patients who do not want to enroll in studies-not a complacent industry. 

Allergan and J&J have mirrored that interpretation, and added that costly and onerous questionnaires-some 27 pages long-have stymied attempts to track patients over the long-term.

Some attempts in Europe have met similar fates. Britain, for instance, set up a registry in 1993.  That registry ran until 2006, when it was shut down due to a loss of funding after it experienced chronic difficulties with having women participate.

Now, with the PIP scandal growing ever-wider, some are calling for a European-wide registry system to track the implants. It remains to be seen if they can surmount the issues that have plagued earlier registry attempts.



Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe