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After Rise of Rare Cancer, FDA Wants Warning on Breast Implants

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Textured implants appear to be linked to a rare form of cancer. Getty Images
  • The FDA is issuing a recommendation that new warnings be included for breast implants.
  • The recommendations come as more people have reported a form of cancer associated with certain implants.
  • Additionally, women can experience other symptoms related to their implants including fatigue, memory loss, rash, brain fog, and joint pain.

The Food and Drug Administration (FDA) released new Food and Drug Administration (FDA)” rationale=”Governmental authority”>guidance Wednesday suggesting “boxed warnings” be included on packaging materials for saline and silicone gel-filled breast implants.

For years breast augmentation has been one of the most popular cosmetic procedures. In 2018, approximately 313,735 people went under the knife for an augmentation.

However, while many people are happy with their implants and experience no complications, about Food and Drug Administration (FDA)” rationale=”Governmental authority”>1 percent of women with implants experience complications or adverse outcomes.

Due to these complications, nearly Food and Drug Administration (FDA)” rationale=”Governmental authority”>20 percent of women opt to have the implants removed.

The FDA’s new recommendations, which have yet to be finalized, are designed to help physicians give patients a better understanding of the potential risks of breast implants.

The recommendations come after the FDA received new information from a Food and Drug Administration (FDA)” rationale=”Governmental authority”>public advisory panel meeting in March regarding the health risks associated with breast implants — such as breast implant-associated anaplastic large cell lymphoma (BIA112 ALCL) along with a range of symptoms caused by a condition known as breast implant illness (BII).

While much of the focus around BIA112 ALCL has focused on textured implants, the FDA’s new recommendations would mean putting a warning on both smooth and textured implants.

“We believe women should have thoughtful and balanced discussions with their healthcare providers about both the benefits and risks of breast implants based on clear and current information. This draft guidance is an important step in making that happen,” the FDA stated in a press release.

The FDA’s recommendations urge manufacturers to list out the health risks in the boxed warning — specifically that breast implants are not lifetime devices and that the risk of developing a complication increases over time.

The FDA also wants the boxed warnings to state that breast implants can increase one’s risk of developing BIA112 ALCL, a cancer of the immune system that causes a mass or pain in the breast implant along with persistent swelling.

The boxed warnings should also mention breast implants may cause systematic symptoms, or BII, including fatigue, memory loss, rash, brain fog, and joint pain, the FDA advised.

The FDA also recommends that a patient checklist be included in all breast implant educational booklets and brochures, which reviews the risks, who a successful candidate for the procedure is, who should not receive the procedure, along with alternative options.

First and foremost, health experts hope women realize that all devices eventually fail and will need to be replaced.

For example, a young women with breast implants will most likely need them to be removed or replaced at least once (or every 10 to 15 years), health experts say.

Replacements or reconstruction may be required for a number of reasons.

“Consideration should be given to the fact that implants are not lifetime devices and may need to be replaced for any number of reasons including: rupture, malposition, contracture or hardening of the implant capsule, infection, pain, rippling, and in rare instances BIA-ALCL or systemic symptoms such as joint pains and auto-immune symptoms,” Dr. Mark L. Smith, the vice chair of the department of surgery at Northwell Health and director of reconstructive oncology at Northwell Health Cancer Institute, said.

In addition, while the new guidance applies to all types of implants, certain implants pose more risks than others, according to health experts.

“Textured implants are believed to be associated with a higher risk of lymphoma than smooth implants,” Dr. Tomer Avraham, a Yale Medicine plastic surgeon who specializes in breast reconstruction, said.

Because textured implants have a higher risk of BIA112 ALCL, most doctors are moving away from them and opting for smooth, round implants instead, according to Smith.

Before undergoing any surgery, including breast implants, health experts agree it’s crucial to first have an open conversation with your doctor about the risks and benefits and probable need for future surgeries.

“I think that any person considering breast implants should have a detailed and frank conversation with their plastic surgeon,” Avraham said.

Women should also have a personal consultation to determine if they’re a good candidate for the procedure.

“It is important for patients to know that a consultation with a physician certified by the American Board of Plastic Surgery Inc., is the best way to acquire individualized examination and consultation to obtain the proper information,” Dr. Gordon Lee, a breast reconstructive surgeon and director of microsurgery-plastic surgery at Stanford Health Care, said.

If you do move forward with the procedure, it’s important to routinely follow up with your doctor.

“After surgery, patients should continue to examine their breasts on a monthly basis, and if they notice something different they should get it evaluated by a physician,” Smith said.

In addition, patients with silicon-filled implants should regularly have an MRI or ultrasound to screen for an asymptomatic rupture of the implants.

Many women are satisfied with their implants, said Smith. But it’s still crucial to be aware of any signs or symptoms that an implant-related problem may exist.

The Food and Drug Administration (FDA) released new Food and Drug Administration (FDA)” rationale=”Governmental authority”>guidance Wednesday suggesting “boxed warnings” be included on packaging materials for saline and silicone gel-filled breast implants.

The new recommendations come after the FDA received new information regarding the health risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA112 ALCL) along with a range of symptoms caused by a condition known as breast implant illness (BII).

The new guidance was designed to give women all the necessary information regarding the risks and benefits of breast implants.


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