Mentor recalls certain saline-filled breast implants due to a potential weakened area that may cause leakage. Affected products include specific model codes and lot numbers listed in the recall notice.
Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
Mentor is recalling specific saline-filled breast implants that may have a weakened area causing potential leakage. This could lead to the implant deflating, which might require surgical intervention.
The implants may have a weakened area on the base patch portion that can cause leakage or deflation. This could lead to the implant losing its intended shape and volume, potentially requiring surgical correction.
Women who received the recalled saline-filled breast implants from Mentor Texas LP. Those with implants manufactured with the listed model codes and lot numbers are most at risk.
Check the product code and lot number on your implant. Affected products include specific model codes (e.g., 3501610/81317001171) and the listed lot numbers provided in the recall notice.
Identify your implant's model code and lot number to determine if it is affected by this recall.
Reach out to Mentor Texas LP for guidance on next steps if your implant is affected.
No, only specific model codes and lot numbers listed in the recall notice are affected.
Contact Mentor Texas LP for guidance on next steps if your implant is affected.
The recall states a potential leakage risk, but no specific injuries have been reported. The hazard is described as a possible deflation, which may require surgical intervention.
We’ve drafted a message you can send Mentor to request your refund or repair — edit it as you like.
Subject: Recall Z-0367-2022 — Mentor Mentor Hello, I own a Mentor that is covered by recall Z-0367-2022 from Mentor. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.