Patients must sign an informed consent form in which all risks are explained and it is underlined that they do not last a lifetime.

It is fine to discuss it at work. The FDA, or Food and Drug Administration, wants plastic surgeons to explain all of the risks involved with breast augmentation and reconstruction surgery to their patients in great detail. And, to avoid any misunderstandings, it will require doctors to tell patients in writing of any risks that may arise, even years after the procedure. The risks and potential side effects will be spelled out in a standard document that all surgeons will provide to their patients.

The FDA made the decision after hearing from women who claimed their doctors had mislead them by failing to notify them about all of the potential problems.

New documents will include old and a new boxed warning: Breast implants do not last a lifetime. The agency does not assign an expiration date to the prostheses, but it does emphasize the importance of reviewing the implants on a regular basis to ensure that they are in excellent working order. Both the patient and their plastic surgeon will have to sign the doc.

Lymphoma risk

Those who are going to undergo this procedure will be informed that they may require additional surgery to change the implants, and they will also have to mention the possible relationship between breast prostheses and a very rare type of cancer known as anaplastic large cell lymphoma. This oncological disease is not a breast cancer, but a benign variant of lymphoma. It is usually cured with the removal of the affected implant and no other type of cancer treatment is usually necessary.

To date, there are no conclusive data on why it may appear. No connection has been found between the disease and the content of the implants (saline or silicone). There are also no differences between those who receive an implant for cosmetic reasons or do it for reconstructive surgery after breast cancer.

Memory loss, pain, fatigue …

The list of possible problems that patients will have to sign also includes other very rare symptoms, but that some women with implants have experienced: memory loss, joint pain, fatigue …

The FDA says its sole objective is to provide future implant users with “clear and understandable information about the benefits and risks of breast implants.”

“Protecting patients’ health when they are treated with a medical device is our most important priority,” said Binita Ashar, FDA’s chief surgical device officer.

The FDA has also modified its requirements on what manufacturers must declare, such as the number of heavy metal compounds in prosthesis.

Image Credit: Getty

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