- On Monday and Tuesday, the Food and Drug Administration (FDA) will meet to discuss the health risks associated with breast implants, CNN reported.
- Days before the meeting, the FDA published warning letters to two breast implant manufacturers that didn’t run required long-term studies about the potential risks of their silicone gel implants.
- There are two main types of breast implants, saline-filled and silicone-filled, and each has its own set of associated risks.
On Monday and Tuesday, the FDA will convene to discuss breast implants and the risks associated with them.
The meeting follows a letter the FDA sent to doctors asking them to watch out for a rare form of cancer associated with the implants. Since September 2018, the FDA has received 457 individual reports on people with implants who developed anaplastic large cell lymphoma (ACLC). Nine of those cases resulted in death.
Additionally, the FDA issued warning letters to two breast implant manufacturers on Sunday after learning they were not running long-term studies to better understand the potential risks of breast implants.
During the meeting, the FDA will discuss the different types of implants available and make recommendations on how to handle their potential risks going forward.
Here’s what to know about the difference between silicone-filled and saline-filled implants.
Silicone-filled implants contain a sticky gel-like substance and tend to resemble real breast tissue
Both types of breast implants have silicone outer layers, but the inner contents of the implants is what sets them apart. Silicone-filled implants contain silicone, which comes in a gel form that resembles human fat, according to the Mayo Clinic.
Some people who opt for silicone-filled implants do so because these implants tend to look and feel more like real breast tissue. You have to be at least 22 years old to get silicone implants for breast augmentation, but can be any age if you need them for breast reconstruction purposes, according to the Mayo Clinic.
If one of these implants ruptures while inside the body, it might go undetected because the gel would remain in the tissue around the implant. Although a ruptured silicone gel implant isn’t linked to breast cancer or other health problems, it can still lead to pain and changes in the size and shape of the breast if left untreated.
To detect silent ruptures, the FDA recommends getting an MRI three years after getting either type of breast implants, and then every two years following the initial MRI. A doctor can remove a ruptured silicone implant and replace it right away if that’s what the patient wants.
In an FDA report published in 2011 on breast implants linked to ACLC, 24 of the 34 cases used silicone implants, while just 7 of the cases were linked to saline-filled implants.
A 2019 National Institutes of Health (NIH) report found that silicone implants are more expensive than saline implants for reconstruction procedures, but that silicone implants proved less effective over time due to revision surgeries and complications. The 2019 report concluded that “given the relatively small cost difference, surgeon and patient preference may be important in determining type of implant used.”
Saline implants are filled with a sterile salt water solution
Like silicone implants, saline implants have a silicone outer shell, but are filled with a salt water solution after the shell is placed in the body. This implant type is available for people 18 and older who want breast augmentation surgery.
If a saline implant ruptures, the salt solution is absorbed into the body. The implant shell deflates and must be removed surgically, but can be immediately replaced just like a silicone implant.
According to the FDA, saline implants are often used in revision surgeries to correct previous procedures.
Implants can also be textured or smooth, and textured implants have been linked to ACLC
In addition to their fillings, breast implants can be characterised based on the feel of their outer shells. Some implants are textured on the outside, while others have smooth outer surfaces. The textured surface of some implants acts like Velcro and helps them to better stay in place, according to Allure. These implants also come in a teardrop shape, which mimics the natural shape of a breast more than a perfectly round implant.
But the texture of the implants could also be a potential breeding ground for harmful bacteria that could lead to inflammation or infection, Adam Kolker, an associate clinical professor of surgery at the Icahn School of Medicine, told Allure.
Researchers aren’t positive if the textured surface is causing ACLC cases, but they do have reason to believe it’s possible, as a 2017 report linked textured implants to ACLC.
Both types of implants may complicate mammograms and breastfeeding
Mammograms may need to be performed differently if a person has breast implants, since the procedure requires the breast to be compressed between two discs. The Mayo Clinic website recommends telling the radiologist performing the mammogram that you have breast implants beforehand to prevent any potential complications, like rupturing your implants.
Breastfeeding may also be a challenge for someone with breast implants, according to the Mayo Clinic, but other women don’t have trouble breastfeeding with implants.
Both types of implants require upkeep and usually have to be replaced every 10 years for routine maintenance, according to FDA standards. They also have similar risk factors in terms of ruptures, infections, changes in nipple sensation, and pain.
Regardless of the type of implants a person gets, both come with potential risks that should be considered before going through with the procedure.
The FDA will also discuss risks associated with women-centric procedures
In addition to talking about ACLC risks, the FDA meetings will discuss common risks associated with breast implant procedures and other women-centric health issues, like the use of surgical mesh, which has lead to past infections in women getting pelvic organ prolapse surgery.
The FDA said it also plans to discuss best practices for informing patients about potential breast implant risks and MRI screenings for detecting ruptured implants.
Susanna Heller contributed to this story.
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