Do breast implants need to be changed every 10 years?

11:57 PM

Q. Should Breast implants be replaced every 10 years? 


A.



Before the FDA approval of cohesive gel in 2006, there was a time when we only used saline solution bag. The various rumors at that time are still on-line today.
What I am surprised at is that there are many surgeons who do not have sufficient knowledge about the breast implants but communicate some common sense knowledge to the patients.

Although many of these surgeons received license from the country, the surgeons, especially those who conduct breast surgery, should have updated knowledge at all times and study the respective field.

The statement that cohesive gel breast implant needs to be changed every 5 or 10 years is not true but there are those patients who ask this question saying that such statement would not have come out if it was completely false.

Rumors without any evidence tend to capture more attentions. The person who tries to communicate the accurate message may be judged falsely by the others. Today, I would like to share the FDA announcement.





In June 2011, FDA announced “FDA update on the safety of silicone gel filled breast implants”. Here are the details. (Source;http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf)



[VII. Summary of Key Findings]

1. Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use.

2. The longer a woman has breast implants, the more likely she is to experience local complications or adverse outcomes. Women with breast implants will need to monitor their breasts for local complications for the rest of their lives.


3. The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other frequent complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others. These observations are consistent with the local complications and adverse outcomes that were known at the time of approval.

4. Women with breast implants may have a very small but  increased likelihood of being diagnosed with anaplastic large cell lymphoma.

5. In the post-approval Core studies, between 20 ~ 40 percent of augmentation patients and 40 to 70 percent of reconstruction patients had reoperations during the first 8 to 10 years after they received  their implants. Although  routine replacement is not necessary, many women will  need additional surgery to modify, remove, or replace their implants.

6. There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. Associations that are very rare or that take many years to manifest may not be detected using currently available data.

7. MRI continues to be the most effective method of detecting silent (asymptomatic) rupture of silicone gel-filled breast implants.

8. Interpretation of the data from  the silicone gel-filled  breast implant post-approval studies may be limited  by low  follow-up rates.




As you can read in the 5th statement, there is no recommendation about changing the cohesive gel implant regularly


The rumor that one need to change the implant every 5 to 10 years comes from the time when the clinics used to use the saline solution bag implants and is still lasting today.

Also, this rumor is used as a marketing means in the clinics that recommend filler or fat transplantation for breast surgeries.




A scientific and accurate information is not “the information that I want” or “the information that I want to hear”. An objective information with numerical data that can be accepted by anyone would be the information that I need.

Thank you for reading the post. Have a great day.

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1 개의 댓글

  1. Such an Informative Article for similar articles or if you wish to undergo Breast Implants Replacement surgery visit our website: http://www.breastimplantsindia.com.

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