Mentor MemoryShape Silicone Breast Implant:
- Approval Date: June 14, 2013
- FDA Overview – Mentor MemoryShape
- FDA Consumer Information
- FDA PMA P060028
- Approval Order (Post-Approval Study Conditions)
- Summary of Safety & Effectiveness
- Labeling Pamphlet #1 (for augmentation patients, from 2013)
- Labeling Pamphlet #2 (for reconstruction patents, from 2013)
- Labeling Pamphlet #3 (mini brochure, from 2013)
- Labeling Pamphlet #4 (for physicians, from 2013)
- Supplements: S001, S002, S003, S004, *S005, *S006, S007, S008, S010, *S011, S012, *S013, *S014, S015, S016
2019 Update – FDA Issues Warning Letter to Mentor:
“We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies.” – FDA Commissioner Scott Gottlieb, M.D.
“The FDA’s warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer’s post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. The action also notes Mentor had poor follow-up rates with patients in the study. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. While the FDA had concluded after reviewing several interim study reports submitted by Mentor that progress on the post-approval study appeared adequate at that time, the agency advised Mentor of concerns about patient enrollment, follow-up rates and data inconsistencies.
Mentor’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.”
Mentor’s MemoryShape Post-Approval Studies (5):
1. Core Study: The overall 10 year follow-up rate was 63%. The overall follow-up rate for the MRI subset of enrolled patients was 43%. Mentor’s MemoryShape had FDA Approval on 6/14/2013 and this was the 1st condition of the approval. This study consisted of continued follow-up on the premarket group of enrolled women. Prior to approval in 2013, this study yielded six years of data, and was designed to follow these women for a total of 10 years after initial implantation. Therefore, the data has been reported cumulatively up to 10 years, the last subject was enrolled on September 13, 2004, and the final report was accepted on Dec 16, 2015.
2. MemoryShape and MemoryGel Post-Approval Study: Intended to follow women for 10 years, commencing in 2013. This study will combine MemoryShape and MemoryGel patient results.
3. Case-Control Study: Terminated. The purpose was to evaluate the association between Mentor MemoryShape Silicone Gel Breast Implants and five rare disease outcomes: rare connective tissue diseases, neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. This study was to be conducted in Denmark, Germany, and the UK.
Case-control studies were later terminated after the release of Tufts’s evidence report. In 2013 American Society of Plastic Surgeons (ASPS) commissioned a systematic literature review to be conducted by Tufts Center for Clinical Evidence Synthesis, funded by three breast implant sponsors, and the advisory board approved the final report on 8/1/2014. (The alarming conflict of interest in the manufacturers sponsoring the studies and in the plastic surgeons handling the study is astounding).
4. Continued Access Study: The overall 5 year follow-up rate was 62%. This study was to continue follow-up for up to 5 years post implantation of patients who received Mentor’s MemoryShape Medium Height Moderate Profile (CPG Style 321) Breast Implants prior to approval but outside of the Core Study. The final report was in 2014.
5. Focus Group Study: To evaluate the augmentation and reconstruction patient labeling through an independent group obtaining responses from patients on the format and content of labeling. This study used 33 patients.
If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for the Post-Approval Studies program. Her email is [email protected] and phone number is (301) 796-6134.
For a timeline of Mentor silicone breast implants, click here.
FDA MAUDE – Adverse Reaction Reports – Inclusive of Mentor MemoryShape Silicone Breast Implants:
Started having a capsule around this date. I still have the textured implant in my body. I fit several symptoms of the rare cancer symptoms. I have contacted mentor and they have informed me a few cases doesn’t make them have to stand behind removing them although i am one clearly having many symptoms. They said fda had done no recalls there for it was my problem and i could take out a loan and pay to have them removed if i was that concerned or worried. They also decided assisting with any cost to my ps office as well. Have been on a medication to help the capsule or blood vessels and it no longer works. My left breast is distorted and double the size of right one from capsule and hardened tissues. I also have pictures of all this. Link.
It was reported via fda medwatch (form #mw5072020) that a patient who underwent primary breast reconstruction for cancer was diagnosed with bia-alcl. The patient underwent implantation with a mentor memoryshape gel breast implant on (b)(6) 2015. The patient developed fluid around the right breast. There was an evaluation conducted on the implant fluid, and the diagnosis of bia-alcl was made on (b)(6) 2017. On (b)(6) 2017, the implant and the capsule were removed. There was no contact information provided, therefore no follow up was completed and there is no additional information available. Link.
It was reported that a female patient of unknown age who underwent breast prothesis implantation with mentor siltex memoryshape medium height, high projection gel implants on (b)(6) 2011 (catalog #3341352g, serial #(b)(4) ) has been diagnosed with bia-alcl in (b)(6) 2017. The patient also reported left breast implant rupture, free silicone in her chest area and enlarged lymphnodes. The patient is still implanted but planned course of treatment is explantation with mentor replacement. She is unsure what other treatments, such as chemotherapy or radiation, would be required. Multiple attempts have been made to obtain more information regarding this complaint, however, no further information has been made available. Link.
Pt with breast implants s/p reconstruction for cancer. Pt was three years out from exchange of implants. Pt developed fluid around right breast implant. Fluid eval done, pt found to have breast implant associated anaplastic large cell lymphoma. (bia-alcl). Implant and capsule removed. Pt found to have smooth gel implants- mentor memory shape breast implant. Link.
It was reported by a physician that a (b)(6) year old female patient was diagnosed with alcl on (b)(6) 2017. This patient¿s medical history includes diagnosis of left breast invasive ductal carcinoma in (b)(6) 2015. She underwent bilateral mastectomy and bilateral tissue expander placement in (b)(6) 2015. The patient had mentor tissue expanders that were implanted from (b)(6) 2015. The patient then had mentor memory shape low high moderate plus profile breast implants (catalog #334-1507, r. Side serial # (b)(4)) implanted in (b)(6) 2015. On (b)(6) 2017, the patient experienced a large right breast effusion that developed over 24-48 hours. The effusion was aspirated and tested using flow cytometry and cd30 ihc and came back positive for bia-alcl on (b)(6) 2017. The time between patient signs/symptoms of peri-implant alcl to definitive diagnosis was 1 week. The patient did not have any complications such as infection, hematoma, or implant rotation during implant course prior to alcl diagnosis. The patient did not experience skin lesions, fevers, night sweats or weight loss. There was no pain, redness, palpable breast mass, or capsular contracture. The lymphoma cells were found in the seroma fluid surrounding the implant. Immunohistochemical and flow cytometry testing showed alk negative and cd30 positive results. This is a pathologically confirmed stage ie primary diagnosis of alcl. Based on histology, there is no capsular involvement. The lymphoma cells were found in the effusion fluid surrounding the implant. The patient underwent bilateral implant removal and capsulectomies with no implant replacement on (b)(6) 2017. The implants were intact and not ruptured upon removal. Link.