For years, patient advocates have questioned the safety of breast implants, but until last fall there wasn't enough data to support their concerns. Now, FDA is re-examining claims that the implants could be linked to an array of health problems—at the same time it is working to ease medical device makers' reporting burdens.
Silicone breast implants' troubled past
In 1992, FDA removed silicone breast implants from the market after the agency's database showed silicone implants were leaking gel into thousands of women's bodies. The database at the time also contained hundreds of reports about autoimmune problems, chronic fatigue, fibromyalgia, and headaches among breast implant patients.
Silicone implants remained off of the market until 2006, when FDA said they could continue to be used provided companies tracked patients for at least a decade. According to the Associated Press, more than half of women dropped out of the studies within two years. FDA around that time began allowing medical device manufacturers with a high number of recurring problems to issue injury reports in bulk, meaning one report could represent thousands of individual cases, according to the Associated Press. As a result, patient advocates said there was no way to determine the actual volume of injury reports coming in to FDA.
Madris Tomes, a former FDA staffer who founded a company to analyze medical device reports, said, "They were told those devices were safe—the FDA would go back and say 'We only have this many reports.'" Tomes added, "It leaves the patients demoralized—they don't understand how many other people are suffering."
New reporting brings more cases to light
But last year, FDA made changes to its incident reporting requirements after a lawyer discovered reports from his clients were not represented in FDA's data.
The agency instructed manufacturers to file reports individually, which correlated with a spike in the number of reports related to breast implants. FDA saw over 4,000 injury reports related to breast implants filed last fall, with another 8,000 coming in the first half of 2018.
However, this past August, FDA again updated its reporting guidance, allowing 90% of medical devices to have their malfunctions reported quarterly instead of individually, the AP reports, except in cases of injury or death. FDA said the change was designed to ease reporting burdens and would allow the agency to "process malfunction reports more efficiently."
Patient advocates call for more transparency into potential complications
Patient advocates are now raising concerns that FDA's new incident reporting policy could make it harder to detect medical conditions linked with breast implants.
Researchers at the University of Texas MD Anderson Cancer Center in September released a study based on the medical device data reported after 2006 that found that some rare health problems, such as anaplastic large cell lymphoma (ALCL), a rare blood cancer, could be more common with silicone gel breast implants. While FDA has said there were "inconsistencies in the data" studied, the agency last year confirmed a link between textured saline or silicone breast implants and ALCL.
FDA is still investigating reports that associate ALCL with breast cancer and has over 400 reports, including nine who died. "There may be multiple factors involved in the development of breast-implant-associated ALCL, such as patient characteristics, operative procedure history, breast implant characteristics—including surface characteristics—and duration the breast implant is in place," FDA said. In early 2019, the agency is scheduled to hold an advisory committee hearing on breast implant safety.
But patient advocates continue to say the agency needs better incident reporting.
Research suggests FDA's MAUDE database for medical device injuries, deaths, and malfunctions is incomplete. According to AP, device names and manufacturers also are often misspelled and there's typically no mention of the device's model. An analysis of the data by the International Consortium of Investigative Journalists revealed 2,100 instances in the past five years where patient deaths were misclassified as "malfunctions" or "injuries."
S. Lori Brown, a retired FDA senior researcher, also said the database is difficult to use to determine how widespread an issue is. "It's a difficult database to use, because there's no good way to confirm what's reported, and there's no denominator—you don't know how many people have received breast implants," Brown said.
The American Society of Plastic Surgeons along with the Plastic Surgery Foundation have embarked on an effort to make a list of all implant patients who have developed ALCL. "The research will also focus on identifying potential risk factors and criteria detection and management of this disease," the groups said.
Implant makers respond
Allergan, which makes breast implants, said, "Based on available scientific information, global health agencies and manufacturers are not recommending any change in implant availability, current practice, post-implant care and check-ups."
Similarly, Mindy Tinsley, a spokesperson for Mentor, another breast implant manufacturer, said the company's implants "undergo extensive laboratory testing before they are submitted to government health experts for a science-based review. Many of our devices undergo careful reviews by not just one, but multiple regulatory bodies around the world."
Regardless, the company said it will continue "to work globally with industry groups, physician scientists and health authorities to better understand the associated risks and causes of this type of lymphoma" (Dunn/Fox, NBC News, 11/26; Hoyer, AP/Sacramento Bee, 11/26).
Get ready-to-use slides on the latest women's health market trends
Want the latest information for your next women's health services meeting? We updated our most popular slides on women's health updated with the latest market trends in 2018 and beyond.
This ready-to-use presentation covers everything from growth outlook and financial considerations to new care management priorities and technology innovations.