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Are Breast Implants Safe Now?

Posted March 25, 2022 in Breast Augmentation

Breast implant safety is a concern for many patients. Verifiable reports and unsubstantiated rumors have both contributed to questions regarding the safety of using implants for breast enhancement. With hundreds of thousands of breast augmentations performed each year, breast implants are among the most heavily monitored medical devices, and thorough FDA scientific investigations have concluded that breast implants are safe for the vast majority of patients. Here, we will go over the known risks associated with breast implants to help you make an informed decision about whether breast implants are right for you.

Are Breast Implants FDA-Approved?

Breast implants, as medical devices, are subject to regulation by the U.S. Food and Drug Administration (FDA). The FDA has a multi-stage process for approving any medical device before it can be used in patients. From initial laboratory studies to extensive human trials, devices are not approved for public use until there is conclusive evidence that the device is safe. This testing process can take months to years, and even after a device is approved, the FDA continues to monitor it for safety with ongoing testing.

The FDA has continued to monitor breast implants since they were first approved in 1976, and on July 24, 2019, they re-certified that breast implants are safe and effective. Both silicone and saline breast implants are FDA-approved and considered safe for use in patients.

Most women with breast implants experience no complications beyond the temporary postoperative recovery period and scarring. Serious side effects and risks are very rare.

What Are the Risks of Breast Implants?

Although breast implants are FDA-approved, there are risks associated with their use. This is true for any medical device used with the human body. Patients should be aware of these risks, as well as their rarity, before getting breast implants.

Surgical Risks and Complications

Risks and complications can result from the implants themselves or from the breast augmentation surgery. Some of the more common risks and complications of breast augmentation include:

  • Capsular contracture: The scar tissue around the implant may tighten, causing pain and an unnatural appearance. This can be corrected with revision surgery.
  • Implant rupture or deflation: The implant may rupture after insertion. This can be corrected with revision surgery.
  • Infection: An infection is a potential risk of any surgery. This is usually prevented by taking antibiotics before and after the surgery.
  • Bleeding and blood clotting: Bleeding and blood clotting are potential risks of any surgery. Close monitoring helps to identify any bleeding or possible blood clots before they become a more serious concern.
  • Scarring: Scarring is a potential risk of any surgery. The type and size of implant will play a role in the degree of scarring.
  • Changes in nipple and breast sensation: The nipple and breast may become numb or have a change in sensitivity after the surgery. This is usually temporary and will improve over time.
  • Pain and swelling: The breasts may be sore, painful, and swollen after the surgery. This is usually temporary and will improve over time.

The risk of major complications with breast implant surgery is generally very low, especially when the breast augmentation procedure is performed by a board-certified plastic surgeon.

Other Potential Safety Risks

There have been reports to the FDA of some more serious health concerns regarding the safety of breast implants. These include breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness.

BIA-ALCL is a type of cancer that develops in the scar tissue and fluid near the implant. As it affects the immune system, it can also spread throughout the body. Most cases do not occur until years after the implants have been placed, and they are usually accompanied by symptoms such as persistent swelling, lump near the implant, asymmetry, hardening, and pain in the breast. Patients who are confirmed to have BIA-ALCL should have their implant and scar capsule removed; chemotherapy and radiation may also be necessary. Although some women have died from it, this cancer is often curable if diagnosed and treated early.

Fortunately, the risk of BIA-ALCL is very low; research suggests incidence rates from 0.003 percent up to 0.026 percent of patients with breast implants. The FDA has not recommended implant removal for patients who do not have any symptoms.

Breast implant illness includes a variety of systemic symptoms which some patients reportedly believe to be connected to their breast implants. Symptoms include chronic fatigue or flu-like symptoms, joint and muscle pain, memory loss, brain fog, migraines, and skin rash. Some affected patients have reported that removal of their implants appears to reverse their symptoms. However, because these symptoms can often be attributed to any number of unrelated health conditions, there is not enough evidence to establish a causal link between these symptoms and breast implants. Research is ongoing into this poorly understood issue.

Breast Implants Are Safe Devices

Patients considering breast augmentation deserve to know these risks, but they should also feel assured by the careful FDA regulation of breast implants that these devices are safe for the vast majority of women. Hundreds of thousands of women undergo breast augmentation each year without experiencing major complications or dangers. The FDA continues to monitor the safety of breast implants and will update the public if new information becomes available.

If you are considering getting breast implants, be sure to talk to your doctor about the risks and benefits of breast augmentation. Only you can decide if breast implants are right for you.

To learn more about breast implants, schedule your personal consultation with our board-certified plastic surgeon Dr. Andres Taleisnik. Call (657) 294-8375 or contact us online today.