Breast Implant Scandal Shows Regulators in Dark on Risk

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.

FAILED TO MEET GOALS

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.

LITTLE INCENTIVE TO KEEP TRACK

The FDA said enrolling patients in follow-up studies was a challenge, and that the agency would work to involve different groups, including advocacy groups and physicians, to make sure patients understand the benefits of sharing information. The agency said the implants were safe enough to stay on the market.

"You can have the most well-meaning company, but if the patients don't want to participate in the study, that's out of their control," said Dr William Maisel, deputy director of the FDA's devices division, at the time.

Some critics say that companies cannot be relied on to track this data, and that a more systematic effort is needed, especially as the FDA itself says women are likely to need to replace their implants every 10 years due to the risk of complications.

"They have fiddled around with this issue (of registries) for over 20 years, and nothing has been done," said Sybil Niden Goldrich, a consumer advocate on breast implants. "We still don't have an accurate rupture rate on these products."

In the late 1980s, Goldrich's own silicone implants, used to reconstruct her breasts after a mastectomy, ruptured and migrated to different locations on her body. She campaigned for the FDA to require implant manufacturers to conduct clinical trials and since 1988, has called for a registry to be created.

REGISTRY MODELS

The FDA and other groups have proposed different models for registries that can track all medical devices, from following patients through their insurance company to allowing patients to voluntarily report complications via an online database.

Patients can currently report problems with implants to the FDA's MedWatch program, a system for keeping track of complaints about drugs and devices, which the agency can theoretically use to detect problems.

But many are not aware it exists. At the FDA meeting in August, the vast majority of the dozens of women who testified on problems with breast implants had not reported their complaints to MedWatch.

Manufacturers and facilities such as hospitals and nursing homes are required to tell the agency of device-related deaths. Reports of serious injuries from devices only have to go to the manufacturer, who then decides what to report to the FDA within a 30-day period.

EUROPE'S EXPERIENCE

Denmark set up a registry in 1999, and data from the first 1,600 women has been used for studies that look at implants' safety. France has no registry for implants.

In Britain, a registry to track breast implant issues was set up in 1993, funded by the government. Reporting was voluntary on the part of the patient, surgeon and hospital.

But few women were willing to take part, and after funding dried up, the registry was shut down in March 2006. An independent review group had previously recommended that the registry be compulsory.

Surgeons and campaigners are now keen to restart it, though they say a better solution would be to have a database that tracks all implants in Europe.

"If we could have a register that was European-wide that would be wonderful," said Douglas McGeorge, a consultant plastic surgeon and a former president of the British Association of Aesthetic Plastic Surgeons. "It would mean that wherever in Europe you were treated, you could always get access to your information."

A European registry may be bolstered by government-run health systems in many countries. But in the U.S., it may not be a panacea, as many implants are not covered by insurance.

U.S. patients and their doctors may not have enough incentives to stay in studies, especially if they have to fill out lengthy questionnaires every year, or do expensive tests to see if their implant has ruptured.

Given those disincentives, Dr. Caroline Glicksman, a New Jersey-based surgeon, said a registry should be mandatory.

"I cannot get women to come back (for follow-up) when everything is fine," said Glicksman, who is now conducting research on Allergan implants. "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."