The Connection Between the FDA and Breast Implants

Breast implants are one of the most widely performed procedures in cosmetic surgery. You may have considered them for reasons ranging from restoring volume after pregnancy to reshaping your figure or to fit a certain beauty standard that’s been marketed for decades. On the surface, they’re presented as a simple solution for body image. But the reality is more complex.

While many women choose implants, the risks can be significant and, for some, life-altering. From chronic pain and autoimmune-like symptoms to implant rupture and certain cancer risks, the trade-off may not be worth it for everyone.

At Executive Plastic Surgery in Bloomfield Township, Dr. Shaher Khan, our double board-certified plastic and reconstructive surgeon, has dedicated his career to exposing the truth about implants. Known as “the king of explants,” Dr. Khan specializes only in safe, complete implant removal. This article reviews how the Food and Drug Administration (FDA) regulates breast implants and why it remains crucial for patients to be fully informed about potential risks.

The FDA’s role in medical device approval

The FDA evaluates medical devices, such as breast implants, to determine their safety and effectiveness before they are released to the market. This process was strengthened in 1976 with the Medical Device Amendments, which set modern testing requirements. When silicone implants were first introduced in the 1960s, these requirements were not yet in place.

In 1992, after rising reports of complications such as implant rupture, autoimmune-like symptoms, and connective tissue disorders, the FDA restricted the use of silicone implants to controlled clinical trials. Silicone implants were later reapproved in 2006 with requirements for manufacturers to conduct post-approval studies to help track long-term outcomes.

Why FDA approval does not always mean risk-free

FDA approval confirms that a device has met regulatory standards, but it doesn’t mean it’s without risk. When it comes to implants, research has shown numerous potential complications over time, including rupture, capsular contracture, and a rare cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), often linked to textured implants.

The FDA has also recently recognized a broader set of patient-reported symptoms now referred to as Breast Implant Illness (BII). These symptoms can include fatigue, brain fog, muscle pain, and autoimmune-like flares. While research continues, the FDA has acknowledged these concerns and encourages patients to be aware of possible outcomes.

The rise of breast implant illness

For years, thousands of women reported mysterious health problems after getting implants: symptoms their doctors often dismissed. It wasn’t until patient advocacy groups pressured the FDA that BII began gaining recognition. In 2019, the FDA held a public hearing where women shared their stories of health declines they associated with implants.

The symptoms of Breast Implant Illness (BII) can vary widely, but many women share a common set of struggles, including:

• Constant fatigue that doesn’t improve with rest
• Brain fog, memory lapses, or difficulty concentrating
• Joint pain or muscle aches that mimic autoimmune disorders
• Hair thinning or unusual hair loss
• Persistent headaches or migraines
• Anxiety, depression, or sudden mood changes
• Recurring rashes, dry skin, or unexplained skin irritation
• Chest tightness, shortness of breath, or heart palpitations
• Swollen lymph nodes or ongoing inflammation
• Digestive issues such as bloating or food sensitivities
• Heightened sensitivity to light, sound, or temperature changes
• Recurrent infections or a weakened immune system

In response, the FDA required a “black box warning” on implant packaging, which is the strongest type of labeling it offers, and, in 2021, introduced a patient decision checklist that surgeons must review with patients prior to surgery.

These measures aim to ensure that patients receive clear and transparent information about potential risks. However, these measures do place the responsibility on patients to ask the right questions and remain informed. In fact, Dr. Khan has treated many women who were unaware of the possibility of BII and only found relief after undergoing complete implant removal.

Why removal may be the safest path forward

If you already have implants, you may wonder what your safest option is. The truth is clear: the only way to eliminate the risks associated with implants is to remove them completely, including the surrounding scar capsule. This is known as en bloc capsulectomy, or as Dr. Khan performs it: the Khan Procedure. By removing the implant and capsule as a single unit, he aims to ensure that no remnants are left behind that could continue to fuel inflammation or illness.

At Executive Plastic Surgery in Bloomfield Township, Dr. Shaher Khan has made it his mission to protect women from these risks by offering only the gold standard of implant removal. If you are questioning your implants or suffering from unexplained symptoms, you deserve real answers and a permanent solution. Contact Dr. Khan today to discuss your options and reclaim your health.