MENTOR Saline-Filled Breast Implants Recalled for Deflation Risk
Mentor Texas is recalling 28,348 MENTOR Saline-Filled Breast Implants due to a manufacturing defect that may cause a weakened base patch, potentially leading to implant leakage or deflation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall without reported hospitalizations or injuries. The manufacturing defect creates a risk of implant deflation or leakage in an implanted medical device, fitting the profile of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
MENTOR Saline-Filled Breast Implants are being recalled due to a manufacturing issue. These medical devices consist of silicone elastomer shells that surgeons inflate with sterile saline solution during implantation.
The defect may create a weakened area on the base patch portion of the implant, which could potentially cause leakage or deflation of the affected device.
Approximately 28,348 implants manufactured by Mentor Texas, LP have been distributed worldwide. U.S. distribution is nationwide across all states and Puerto Rico. International distribution includes Canada, Spain, United Kingdom, Germany, France, South Korea, Australia, Taiwan, Belgium, Ireland, Turkey, and Singapore. Specific affected product codes and lot numbers have been identified by the FDA.
Patients who have received these implants should contact their surgeon or healthcare provider to determine if their implant is part of the recalled lot. Healthcare providers should review the affected product codes and lot numbers and discuss appropriate follow-up care with their patients.
The recalled product
- Product
- MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available…
- Manufacturer
- Mentor Texas, LP.
- Category
- Medical Device — Breast Implants
- Affected units
- 28,348
Distribution
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