BREAST IMPLANT SAFETY: New FDA Safety Requirements and What They Mean for Our Patients 

In the fall of 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants to make informed decisions. 

Dr. Gurley’s number one priority is patient safety. She takes these new requirements very seriously and is sharing these updates below as well as the rigorous protocols she practices and requires of her patients. 

The FDA has provided adequate risk information for patients considering breast implants. This includes a patient decision checklist to ensure a fully informed decision can be made.  

For purposes of this article, Dr. Gurley is providing a condensed yet comprehensive summary of the much longer Patient Decision Checklist that both patient and surgeon will sign prior to surgery. Herein follows those targeted acknowledgements: 

  1. Prior to surgery, surgeon and patient must rule out certain medical conditions such as infection, untreated cancer, pregnancy/nursing. 
  2. Surgery risks are higher if the patient: smokes, has diabetes, uses immunosuppressive medications or steroids, has experienced chemo or radiation therapy, or possesses a blood clotting or blood flow abnormality.  
  3. More research is needed to better understand risks associated with autoimmune disease, mental illness and prior breast tissue manipulation. 
  4. Possible side effects caused by implant surgery include: pain, numbness, shape and position changes of the breast, infection, swelling, fluid collection (seroma), bleeding, tissue loss, inability to breastfeed, anesthesia complications, nerve or muscle damage, and difficulty imaging breast tissue.
  5. Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), although rare, can occur with as high as 1 in 3800 patients, can take several years to show up and is more common with textured devices. 
  6. Breast Implant Illness (BII) has been reported in some women with implants. Their symptoms may include: nausea, fatigue, brain fog, joint pain, rash, or memory loss. 
  7. Implants are NOT lifetime devices and each implant company includes a lifetime warranty with the purchase of each implant.  
  8. Scar tissue can occur around an implant which may cause tightness or distortion of the implant, known as capsular contracture, and although rare may necessitate further surgery.  
  9. It is likely that additional surgery on the breast may be needed or wanted in a patient’s lifetime to change the size, position or type of implant, or simply to remove their implants due to a variety of reasons including weight fluctuations, pregnancy or aesthetic ideals.  
  10. There are alternatives to implants such as fat grafting or lifting the breast which should be considered.  
  11. The FDA recommends monitoring the breast implant integrity with MRI or ultrasound 5-6 years after surgery and every 2-3 years thereafter.  
  12. Patients receive an implant identification tracking card, a Patient Educational Brochure and a Patient Decision Checklist and links to additional safety information which can be found on the manufacturer’s website.  

The Patient Decision Checklist is included in the Patient Education Brochure and is company specific. The checklist is meant to open conversation and have healthy discussions with your surgeon.  

Dr. Gurley has found most of her patients continue to move forward with breast implant surgery to enhance their body. They feel well informed and are willing to accept these risks and recommendations.  

If you currently have breast implants and are considering having them replaced or removed, now is the perfect time! Why? Visit Dr. Gurley’s blog, “Breast implants Aren’t Going Away Anytime Soon” which addresses the longevity of implants and how to keep your breasts beautiful.  

Finally, please do not hesitate to contact our office with additional questions or concerns regarding breast implants and the FDA’s newest guidelines. 

No one will know… Everyone will notice.

Judy Gurley, M.D., F.A.C.S.

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