Registries for Breast Implants?

September 1, 2011
55 Views

I’m sorry I couldn’t attend the Food and Drug Administration advisory committee meeting the past two days that learned the two manufacturers of silicone gel breast implants — Allergan and Mentor — failed miserably in enrolling sufficient women for the required follow-up studies of their safety.  According to MedPage Today, “Allergan has mustered only about a 60% follow-up rate after two yea

I’m sorry I couldn’t attend the Food and Drug Administration advisory committee meeting the past two days that learned the two manufacturers of silicone gel breast implants — Allergan and Mentor — failed miserably in enrolling sufficient women for the required follow-up studies of their safety.  According to MedPage Today, “Allergan has mustered only about a 60% follow-up rate after two years for its studies — far short of the goal of 93% — and only one in four patients who received a Mentor implant were followed up after two years.”

I’m sorry I wasn’t there because I would like to have heard the tenor of the questions coming from the outside advisors, and the FDA presentation. What was the company’s excuse? It turns out that both companies asked participants in the studies to complete 25-page questionnaires every year! No wonder most women said “no thanks.”

The advisory committee’s solution? Set up a registry, which will depend on plastic surgeons following their patients and reporting outcomes data. Good lord. Why should we think a voluntary reporting system that relies on the good will of hundreds if not thousands of surgeons, few of whom are reimbursed by insurance and most of whose clientele is more concerned about breast size than health, will be any more successful in collecting data than demanding that two  companies collect the data? It seems to me the companies should be the ones required to set up a fool-proof system for conducting the required decade-long studies. And if they fail to enroll sufficient patients in such studies within the next two years, the devices should be pulled from the market. This will provide Allergan and Mentor with the proper incentives for gathering the requisite information for learning definitively whether there are serious health concerns associated with long-term use of silicone gel breast implants.

You may be interested

Why Universal Healthcare is the Key to a Healthier and More Productive Society
Health care
343 views
Health care
343 views

Why Universal Healthcare is the Key to a Healthier and More Productive Society

Helen Heather - August 23, 2017

The United States remains the only country in the world without a universal healthcare system. Many critics have stated that…

Care On The Road: How Telemedicine Can Reach Truck Drivers
Mobile Health
16 views
Mobile Health
16 views

Care On The Road: How Telemedicine Can Reach Truck Drivers

Larry Alton - August 21, 2017

Telemedicine is considered a powerful tool for individuals living in rural areas, far from adequate services or in need of…

Where Is The Balance? Pushing Back Against Consumer Health Tech
eHealth
6 views
eHealth
6 views

Where Is The Balance? Pushing Back Against Consumer Health Tech

Larry Alton - August 18, 2017

When Republican Congressman Jason Chaffetz glibly remarked that Americans struggling to afford insurance should choose between that and their smartphones,…