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FDA calls for removal of textured breast implants from market

Published on Friday, July 26, 2019

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Textured breast implant manufacturer Allergan issued a worldwide recall after the Food and Drug Administration (FDA) requested their removal on Wednesday.
 

Textured breast implant manufacturer Allergan issued a worldwide recall after the Food and Drug Administration (FDA) requested their removal on Wednesday.

 



Enlarge photo

A breast implant infected with bacteria looks yellow.

A breast implant infected with bacteria looks yellow.

More than 4,000 women get breast implants each year. One out of 10 of these women have received textured breast implants.

Textured breast implant manufacturer Allergan issued a worldwide recall of its products after the Food and Drug Administration (FDA) requested their removal on Wednesday. Magnolia Plastic Surgery wants to make sure the public is aware and advises patients to make an appointment to discuss the risks. 

When women with this type of implant were found to be at higher risk for anaplastic large cell lymphoma (BIA-ALCL), the recall was made in response. 

The recall encompasses all BIOCELL textured breast implant products and tissue expanders, including:  

• Natrelle Saline-Filled breast implants 

• Natrelle Silicone-Filled breast implants 

• Natrelle Inspira Silicone-Filled breast implants  

• Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implant 

• Tissue expanders used by patients prior to breast augmentation or reconstruction, including  

• Natrelle 133 Plus Tissue Expander 

• Natrelle 133 Tissue Expander with Suture Tabs 

“As plastic surgeons, our first priority is patient safety,” said Dr. Michael Orseck, plastic surgeon with Medical Group of the Carolinas — Magnolia Plastic Surgery. “With the recent data regarding breast implant associated BIA-ALCL, continuing routine follow up with your surgeon is important. This is especially important if you have noticed a change in one or both of the breasts.”

Worldwide, there have been 573 unique diagnoses of BIA-ALCL with 33 deaths. Of these cases, 481 were attributed to Allergan implants.  

Macro-textured implants (the type Allergan manufactures), represent less than 5 percent of all breast implants sold in the U.S., according to the FDA. 

The FDA does not recommend removal for patients without symptoms due to potential risks, according to Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. 

“We understand that today’s news may be alarming to some patients with breast implants,” Shuren said. …  “but we provide helpful information for patients and providers to consider when discussing next steps.” 

If a patient has textured breast implants, the patient should speak with their provider to consider next steps, according to the FDA. Patients should also monitor symptoms, including swelling or pain near the breast implant and any unusual changes in the body. 

Patients of Medical Group of the Carolinas — Magnolia Plastic Surgery should contact 864-560-6717 with any questions. 

 

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