The Federal Food and Drug Administration (FDA) released new safety recommendations for breast implants on Wednesday.
The federal agency indicated in a statement that it seeks to improve communication about the risks associated with implants, so it
will require that people receive detailed information
from their health service providers about possible complications and benefits before they obtain them. .
It will also require implant manufacturers to include a warning on their product packaging, something that is only required for drugs or products that carry a higher risk.
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The measures seek to strengthen the security of the devices, which have been linked to health problems for decades.
About 400,000 people a year receive these types of implants
, which are used primarily to increase breast size - the most common cosmetic surgical procedure in the United States.
But one in four people get implants after breast cancer surgery, as reported by
The Associated Press
news agency
.
Archive image of a Johnson & Johnson silicone breast implant Donna McWilliam / AP
The FDA had originally proposed the rules as voluntary measures in 2019, but now they will become legal requirements for both manufacturers and physicians.
Johnson & Johnson and Allergan are among the leading manufacturers.
However, the most notable change is the requirement for plastic surgeons and other healthcare professionals who work with implants to provide their patients with a list detailing
possible side effects, including scarring, pain, rupture. and even an unusual type of cancer
.
This list also explains that breast implants often require multiple surgeries and should not be considered lifelong devices.
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Before they can proceed with the surgery, both physicians and their patients will need to sign the document and healthcare providers will be required to explain each item on the list.
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Companies that sell implants to doctors who do not comply with the requirement could face fines and other penalties from regulators.
In addition, healthcare professionals should regularly test implant patients for possible ruptures in the devices, which have a silicone outer shell and are filled with saline or silicone.
The rules will go into effect within 30 days.
In recent years, regulatory agencies have grappled with a link between a rare cancer and a textured type of implant.
Thousands of people have also reported other health problems with their implants,
leading to rheumatoid arthritis, chronic fatigue, and muscle pain
.
With information from The Associated Press.
