Breast Implant Scandal Shows Regulators in the Dark

SUMMARY: The recent scandal over use of improper materials for breast implants shows that, despite efforts to track implants and issues, regulators simply aren't able to keep up.
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WASHINGTON (Reuters) - Long before the latest global breast implant scare, American health officials were toying with the idea of building a registry that would track patients with implants.

The registry would give a better idea of the number of complications over time, such as rupture or infection.

But to this day, none exists for the world's largest healthcare market, which often serves as a global model for regulatory practice. Some individual countries in Europe have made their own attempts but with only limited success, and there is no continent-wide registry.

In the wake of the current scandal surrounding France's Poly Implant Prothese (PIP), which used industrial grade silicone instead of medical grade silicone in implants placed surgically in some 300,000 women worldwide, advocates for a registry are again pushing the idea.

The French government has advised the 30,000 women in France who bought the implants to have them removed and governments in several other countries, such as Britain and Brazil, have asked women to visit their doctors for checks.

"If we had had registries, we would have known years ago if it's true that PIP implants break sooner," said Diana Zuckerman, president of the National Research Center for Women & Families. "We would have known if Mentor ones break sooner or later than Allergan's," she said, referring to the two largest makers of breast implants.

There were almost 400,000 breast enlargement or reconstruction procedures in the United States in 2010, according to the American Society of Plastic Surgeons. That includes silicone and saline implants.

The U.S. Food and Drug Administration has relied on company-funded efforts to track the safety of implants since allowing the silicone versions back on the market in 2006. It had banned silicone implants in 1992 after some U.S. women said the devices leaked and made them chronically ill.


The approval given to Allergan and Johnson & Johnson's Mentor unit was conditional on the companies each following 40,000 women who received the implants for 10 years, as well as extending smaller pre-approval studies.

In 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.

Consumer and patient groups have criticized the two companies for failing to meet the goals. They have asked the FDA to revoke Mentor's marketing approval and to force Allergan to conduct further studies.

In addressing low response rates, representatives of both companies said the studies may have tried to keep track of too many patients and included overly cumbersome requirements, such as filling out a 27-page questionnaire each year.

Allergan offered patients $20 to participate in the study, and $100 for each office visit, while doctors were paid $200 for enrolling each patient. Mentor did not offer any cash incentives to patients but gave doctors $100 for each participant.

In August, Mentor attributed its low response rate to a switch in policy. While it initially required patients to participate in the study if they wanted to buy an implant, it later made that participation voluntary.

Mentor and Allergan both expressed support for a registry at the FDA's meeting in August. But the companies, physicians and regulators have so far failed to reach an agreement over who will pay for it, how information will remain private and whether participation will be mandatory.

The concept of a registry is a good one, but carrying it out is complicated, said Allergan spokeswoman Caroline Van Hove.

"There has been already plenty of discussion with the FDA to really logistically figure out how you would do this," she said. There has been no agreement on a methodology and a system that would work for all implants and all patients, Van Hove added.

Mentor said it is committed to working with the FDA to monitor implant safety, through registries or clinical studies.

So far, the companies' studies have found similar rates of complications such as rupture and hardening of the device, and no apparent link between silicone implants and connective tissue disease, breast cancer or reproductive problems -- though the FDA said the low level of participation meant this wasn't conclusive.

Problems with tracking

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