In late February, the FDA approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant for breast augmentation in women age 22 and older and breast reconstruction in women of any age.
It surprises us that the FDA did not hold a public Advisory Committee Meeting prior to approval. All we found was the press release, which notes the FDA based its approval on seven years of data from 941 women, a relatively small number:
Most complications and outcomes reflect those found in previous breast implant studies including tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection. In addition, investigators observed fissures (cracks) in the gel of some Natrelle 410 implants. This is a characteristic called gel fracture and is unique to this implant.
The issue was not reported in a six-year study of the Natrelle silicone gel implant, published in the August 2012 issue of Aesthetic Surgery Journal.
That study was funded by Allergan (and led by a researcher who is a paid consultant, royalty recipient and stockholder in Allergan). Studies paid for by manufacturers are not uncommon, but it makes it harder to tell what sorts of biases there might be in the results. In this case, researchers noted that between 19 and 43 percent of women required additional surgery — the number varied by whether the implants were for augmentation, revision or reconstruction. The researchers also reported that between 5 and 14 percent of patients experienced an implant rupture.
The FDA also did not post approval documents online, so the seven-year data, which would possibly include newer research results, is not readily available to the public.
The FDA has long known about the temporary nature of silicone gel breast implants. In 2011, the FDA released a report on their safety, urging women to “assume that you will need to have additional surgeries” — a point the FDA reiterated in the press release announcing approval of the Naturelle 401:
“It’s important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
“The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Shuren. “We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness.”
Diana Zuckerman, president of the National Research Center for Women & Families, criticized the approval, questioning why a public meeting wasn’t held and noting that “Allergan has not done a good job of doing post-market studies once their implants have been approved.”
“It seems likely that the FDA decided it was better to hide this information than to make it public at a meeting where implant patients could talk about the health problems that have been caused by these implants,” wrote Zuckerman, who has written frequently about the safety of breast implants.
The FDA is requiring additional “post-approval” studies on several aspects of the Natrelle 410, including study of long-term outcomes in more than 2,000 patients followed over 10 years; rare adverse events in a study to include at least 11,500 women; collection of additional safety and effectiveness data; improvement of the format and content of the patient labeling; and analysis of implants that are removed and returned to the manufacturer.
The additional studies will help determine the risks of these implants. Unfortunately, the results won’t be known for years. In the meantime, women will have implants in their bodies that have not undergone a rigorous review.