Like other Trump agencies, the U.S. Food and Drug Administration said it listened “carefully” to problems, then decided to side with industry anyway.
Regulatory agencies around the world have been considering banning breast implants because of an increased risk of developing breast implant-associated-anaplastic large cell lymphoma or BIA-ALCL, especially with textured implants.
Textured breast implants, covered by a grained outer shell, are designed to stay in the same position over time and prevent scar tissue from forming around the implant.
The rare BIA-ALCL isn’t breast cancer but is a lymphoma that develops in scar tissue.
As of Sept. 30, 2018, the FDA had received 457 medical device reports of BIA-ALCL, including the death of nine patients. Of those, 310 were caused by textured breast implants.
Rather than banning textured breast implants like France, the FDA said it will consider stronger warnings about the breast implants and require improved reporting on problems with implants.
“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act,” the FDA said in a statement.
About 300,000 women have breast implants annually for cosmetic reasons and an additional 100,000 have them following surgery for breast cancer.
In addition to reports of BIA-ALCL, the FDA said it has heard from patients that their implants may cause immune system problems such as chronic fatigue, cognitive issues, and joint and muscle pain. The agency said it doesn’t have definitive evidence on breast implant illness, but the current evidence supports that some women’s symptoms go away when their breast implants are removed.
The FDA wants women considering a breast implant to be aware of these risks, and the agency is considering ways to help to women have the information they need to make informed decisions about whether to get breast implants or to remove existing breast implants to reverse symptoms.
The agency said it’s looking at ways to incorporate product ingredient information into the labeling in a way that’s easy for patients to understand.
“The FDA would work with stakeholders, including patient groups, on the content and format of any labeling changes proposed or recommended by the FDA, which could include a boxed warning and a patient decision checklist, and would work with manufacturers on implementing any changes to the information they provide to health care professionals and patients, including labeling,” FDA Principal Deputy Commissioner Amy Abernethy, M.D., and Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The FDA said it’s aware that there are some health care professionals, such as gynecologists, dermatologists, internists, and pathologists, who may not be fully aware of breast implant risks, such BIA-ALCL and systemic symptoms.
“We are committed to doing what we can to reach them with this important information,” Abernethy and Shuren said.
In addition, they said the FDA is committed to continuing to update the public about any new information related to breast implant risks, including updating information it has for women on its website.
The FDA said it has ended all summary reporting of breast implant medical device reports.
Breast implant manufacturers will now be required to file individual medical device reports that will be publicly available in the Manufacturer and User Facility Device Experience or MAUDE database. For past data received through summary reporting, the agency said it will also be making this data publicly available in the coming weeks.
The manufacturers of textured breast implants are Allergen, Sientra, and Mentor.
In the United States, textured breast implants make up less than 10 percent of breast implants sold. In other markets where bans are being considered, the use of textured implants is much higher, sometimes as high as 80 percent of the market share.
An FDA advisory committee held two days of hearings in March on complications from breast implants. The panel recommended that the FDA require manufacturers to provide health warnings to patients that are more clear and less complex. However, the panel didn’t recommend banning any of the various kinds of implants.
Public Citizen, a consumer advocacy group, has raised concerns since 1973 about serious health problems linked to breast implants. It said there should have been much more extensive mandatory pre-approval testing on permanently implanted devices rather than post-approval trials to obtain information that should have been derived before.
Women are serving as unwitting guinea pigs for breast implants, said Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group.
Sandra Rush, whose story is told in the CBS video above, was shocked that she got a rare form of lymphoma because she had a breast implant following surgery for breast cancer. Although Rush's cancer spread throughout her body, she survived after five rounds of chemotherapy.
