Mentor Approval with conditions--7-2
Thanks to Pam Dowd for sending this news from the FDA panel hearings. . .Sadly, Mentor has approval (with conditions). We can only hope at this point that the FDA will rejects it's panel's approval.
I still find it odd that Inamed had 3 year studies, and was rejected, but Mentor with only a 2 year study was able to prevail.
Myrl
Blumenstein and Newburger voted not to approve with these conditions.
Conditions Discussion.
1. Motion for educational component. Dr. Leitch moves for educational condition/Dr. Miller seconds
Hands-on Training (Dr. Miller--to require that any surgeon prove he/she knows how to handle the device.) Surgeon to be either board certified or board eligible. NOT AN FDA ENFORCEABLE CONDITION.
VOTE: UNANIMOUS
2. Dr Li proposes that sponsor continues to supply the data collection/information they have already been supplying. If they do not file reports, FDA to call panel to review. No faith in registries.
Dr. Newburger proposes a panel meeting to review data in 5 years (from now). Concerned over ignored patients.
VOTE: UNANIMOUS
3. Dr. Blumenstein proposes independent monitoring committee, following FDA guidelines. including advocates from both sides of issue. Focus on safety.
VOTE: 8-1 Dr. Ewing voted not to accept this condition.
4. Dr LoCicero proposes separate and distinct patient educational process for informed consent for patient.
VOTE: UNANIMOUS
5. Dr. Leitch proposes study that core study be amended to include followup for patients who have had implants removed and patients be re-consented.
Dr. Blumenstein wants sypmtoms to be followed on all patients, including patients who are explanted without re-implanting.
VOTE: UNANIMOUS
6. Dr Newburger proposes voluntary registry of as many patients as possible to participate, guidelines including MRI data, CTD, explant data, intracapsular data, pregnancy, mammography results, silent rupture, signs and symptoms, and health outcome of children born to women with breast implants. Dr. Blumenstein seconded because children are included.
Discussion: Dr. Miller doesn't believe data is available for a problem with children. (Children have never been studied.) Dr. Miller suggests that doctors who do not follow through with follow-up will lose their ability to use implants. Dr.Leitch doesn't want to step on sponsor's toes. Dr. Newburger
VOTE: 8-1 Dr Li opposes
7. DID NOT PASS--Dr. Blumentstein proposes voluntary sub-study of core study of signs and symptoms and life-style in individuals with CTD who change scores and more frequent followup. Blood and Urine tests to be required.
Dr. Newburger seconded.
VOTE: 2-6 Blumenstein and Newburger voted for this condition. Dr LoCicero abstained.
8. Dr. Li proposes sponsor fulfills all post-market recommendations conditions as provided by sponsor in application.
VOTE: UNANIMOUS
9. Dr. Leitch proposes tracking device. Physician to provide mail-in card to patient to track in case of recall.
VOTE: 8-1 Dr. Blumenstein voted not in favor.
10. Choti: Add to labeling a recommendation for MRI scan or other appropriately sensitivity powered examination at year 5 and every 2 years afterwards.
Consider implant removal if there is evidence of silent leak.
Newburger --does not eliminate need for regular mammography.
Silent leak the recommendation is that device be changed or removed.
VOTE: Passes-5-4
7-2 Final vote to approve with conditions.
Blumenstein, Newburger voted against approval.
