It’s a unique kind of double-punch to be told something is “all in your head,” especially when it comes to your health. When this happens you still have the problem you came in with, and now you have the pain of feeling unheard. The FDA recently did something to remedy this for a group of women who have concerns about the safety and relative risks of breast implants—they listened.
In late March the FDA held a public hearing to address concerns about breast implant safety. Women who have had breast implants, physicians, and manufacturers were allowed to speak openly before a panel of experts over the course of two days. “We do not feel we have been effectively and appropriately informed,” said one of the women at the FDA hearing. Attendees asked for increased transparency by manufacturers and improved patient access to information on risks associated with breast implants.
Two primary health and safety issues were raised, one of which was the subject of our recent blog post, Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). BIA-ALCL is a rare complication associated with some textured implants that was identified in 2017. At the time of discovery the FDA issued a warning, and we also wrote a post to help our patients understand BIA-ALCL.
The other issue is also rare. It is a difficult to describe condition called Breast Implant Illness. The problem, which includes a variety of vague symptoms like joint pain and fatigue, has often been dismissed by doctors and manufacturers. This is largely because the condition is poorly understood, and no definitive cause is known. Some research has suggested that the symptoms may be associated with an autoimmune reaction, but the authors of these studies concede that their findings show association but not causation.
Breast implants are not the only thing associated with these kinds of symptoms. The FDA recently released a statement warning that a small number of patients may have similar biological reactions to a wide array of implantable devices. As with breast implants this is also in need of much more study.
“Although there is no scientific evidence to date to support diseases/illness being caused by breast implants,” says Dr. Slack. “I don’t think it is unreasonable to believe that there are some people whose immune systems react strongly to having a breast implant or an implanted device in place. This is a very small number and is certainly not a common occurrence; nonetheless, it should be discussed when considering breast augmentation along with the other potential risks of breast augmentation surgery.”
A big takeaway here is that if you have had any adverse reaction to a surgical implant or have a history of an autoimmune disorder or allergies, it is important to discuss this with your surgeon. It is also important to follow your surgeon’s instructions regarding long term follow up after getting breast implants.
Despite the risks, the news at the FDA hearing wasn’t all bad. Decades of research has also shown breast implants to be safe for most women, and complications are rare. One cancer survivor relayed how her breast implants hadn’t been problematic and were, in fact, integral to her recovery after a double mastectomy. She hopes implants can remain an option for future patients like her.
“The meetings concluded with the panel recommending that the FDA require manufacturers to provide simpler and clearer health warnings to all patients,” according to this Atlantic article “but stopped short of encouraging a ban on any particular type of implants.”
The FDA hearing underscores the notion that good medicine requires a careful and well informed balance of risk and reward. In addition to finding a physician who is highly qualified, you also need one who is up to date and can adequately explain the risks of any procedure or treatment. On top of that, you need someone you can really talk to. Someone who knows that hearing what you have to say is an integral part of the equation.
If you are considering breast implants and want to know more about these issues, make an appointment with Dr. Slack today. He will be glad to give you the answers you need, and if you have concerns, he’s ready to listen.