Federal regulators have toughened the requirements for surgeons and medical device makers to inform women in detail about rising risks associated with breast implants, which also now will carry the government’s sternest warning — a “black box” label cautioning about the products’ potential harms.
The implant alarms, announced after years of complaints by patients, include the Food and Drug Administration’s counseling women that implants carry significant complications and should not be considered long-lasting products, secure for extended periods after surgery. The agency also ordered manufacturers to disclose ingredients used to make the devices.
The FDA, which is seeking public comment on its new oversight, has issued a 22-page document that describes how doctors and makers should discuss with patients the risks of implants.
As the New York Times reported:
“[T]he [agency’s new] warnings and a new checklist that advises patients of the risks and side effects state that breast implants have been linked to a cancer of the immune system and to a host of other chronic medical conditions, including autoimmune diseases, joint pain, mental confusion, muscle aches and chronic fatigue. Startlingly, the checklist identifies particular types of patients who are at higher risk for illness after breast implant surgery. The group includes breast cancer patients who have had, or plan to have, chemotherapy or radiation treatments. That represents a large percentage of women who until now were encouraged to have breast reconstruction with implants following their treatment …
“The patient checklist states explicitly that there are some medical conditions that should preclude women from getting implants … In addition to breast cancer that has been treated, those conditions include active infections, existing cancer or pre-cancer of the breast that has not been treated, pregnancy, and nursing. Women with diabetes, which can make healing difficult, and lupus, which interferes with blood clotting, are also listed as having a higher risk of a poor outcome. So, too, are smokers and former smokers.”
The Washington Post, referring to patients’ long problems with implants, including those described in a packed and angry 2019 meeting with regulators, described how consumers prodded the FDA to act:
“The new requirements follow years of complaints from tens of thousands of women who received breast implants and later suffered from brain fog, fatigue, and other health issues, collectively known as ‘breast implant illness.’ Some implants have also been linked to a rare, life-threatening form of cancer. Activists have long sought an informed consent process for patients so they have a clear understanding of the risks and benefits before they opt for surgery.”
It is unclear, the New York Times reported, how the FDA will enforce its new implant requirements, though the Washington Post reported that the agency has said it will restrict sales of the devices to institutions that provide patients extensive counseling on complications with them.
The black-box labeling, which is the strongest warning the agency provides to patients about highest-risk prescription drugs and medical devices, will appear on the implant packages — which surgeons and medical personnel handle and consumers rarely see, the New York Times reported.
The FDA is urging women, whether they have implants filled with saline or silicone gel, to ensure they get regular checkups to ensure the devices are not leaking. These screenings may not be covered by their health insurance — a cost that patients now must be informed of, the FDA says.
In my practice, I see the harms that patients suffer while seeking medical services, notably the many ways in which the medical establishment long has mistreated women, including by “innovating” with their care with procedures and medical devices that too often have proven to be dangerous and defective products.
It is disturbing that the FDA finds itself ordering device makers, in a heightened level of implant warnings, to provide women patients one of their basic rights — the fundamental right to informed consent. This means they are told clearly and fully all the important facts they need to make an intelligent decision about what treatments to have, where to get them, and from whom.
If you’re a certain age, it’s hard to watch yet another blow-up over breast implants, which caused lawsuits to stack up in the courts in the 1990s. The devices can be helpful, appropriate, and responsible for women. But implants’ increasing popularity, notably for elective augmentation, should give pause. This is truer because of what we know both about the device’s durability and what occurs with breast procedures.
As an international investigative journalists’ group has reported:
“The FDA’s own safety notices warn that as many as one in five women who receive breast implants will get them removed within a decade due to complications such as rupture, deflation, and the painful contraction of scar tissue around the implant, known as capsular contracture.”
“Surgeons who perform reconstructive breast procedures learned only recently — to their surprise — how burdensome the procedures can be for patients: 1 in 3 women develop postoperative complications over the next two years, with 1 in 5 requiring more surgery, and in 1 in 20 cases, the reconstruction failing, [according to] published findings of medical researchers.”
The FDA is requiring doctors and makers to conduct more, randomized clinical trials to provide desperately needed, clear data about the risks and benefits of breast implants. That’s a fine idea. We have much work to do to ensure patients’ safety with these devices and to ensure that the medical establishment never is dismissive of potential harms to women’s health.