Of the 400,000 breast implant surgeries performed annually, the Food and Drug Administration had reported only about 200 complaints each year of defects or health problems.
But a recent change in FDA reporting methods reveals that in fact there are many thousands of complaints. And the incidence of a rare cancer linked to breast implants may be more prevalent than thought.
Hey, that’s kind of deceptive!
FDA reports seemed to indicate that breast implants were safe. The 200 or so complaints were just a fraction of a percent of the hundreds of thousands of women who had implant surgeries each year.
Manufacturers of saline and silicone implants are required to report problems, such as ruptures leading to surgery to remove or replace the devices. But for many years, manufacturers were allowed to include all defects in one big report – which the FDA only counted as one issue!
After the FDA changed the rules in 2017 to require reporting of individual cases, they were flooded with complaints about implant failures, surgery complications and health problems from breast implants. There were more than 4,000 individual complaints for 2017 and at least 8,000 so far in 2018. Instead of an insignificant fraction, the actual rate may be 1 to 2 percent of all 400,000 implants performed each year.
Were women given informed consent of the dangers?
Women’s health advocates and implant recipients who have experienced health complications are incensed. They feel that manufacturers were deceptive about the risks and that the FDA enabled the disingenuous reporting.
In addition to the underreported failures or problems with breast implants, the FDA has acknowledged a link between implants and anaplastic large cell lymphoma. The cancer, though rare, is associated particularly with textured implants.
More than three-fourths of breast implants are elective cosmetic procedures. (The rest are reconstructive surgeries, such as after mastectomy.) Many women who have experienced complications or who worry about getting ill may not have chosen implants if they knew the true risks. Some are considering product defect lawsuits against the medical device companies.
Better tracking needed for medical device safety problems
Breast implants, like other medical devices, are manufactured with a unique device identifier (UDI). Manufacturers have the ability to track problems to specific products, but they have been resistant or cagey. Because cancer or complications may not develop for many years, those long-term connections are not being captured and implant recipients may not be fully informed.
An FDA committee will re-examine the dangers and its public health advisories. If the risk is deemed to be substantial, the FDA could even require a “black box warning” on future implants.