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BREAST IMPLANT MENTOR H/S Reports 1998-2010
Medical Device Brand Name: MENTOR H/S 350-18
Medical Device Generic Name: BREAST IMPLANT
Medical Device Manufacturer Name:MENTOR H/S


BREAST IMPLANT MENTOR H/S Report # 148243
PT HAD BILATERAL BREAST IMPLANTS 4/30/93. LEFT IMPLANT FOR MICRO MASTIA, RIGHT IMPLANT FOR SYMMETRICAL TO LEFT AFTER IMPLANT, 10/97- LEFT IMPLANT FOUND TO BE LEAKING. 2/5/98- BOTH IMPLANTS REMOVED AND REPLACED. LEFT IMPLANT WITHOUT SALINE AT REMOVAL RIGHT IMPLANT SAME AS LEFT IMPLANT DATE.

BREAST IMPLANT MENTOR H/S Report # 148008
BILATERAL AUGMENTATION 10/29/97. RT BREAST IMPLANT PREVIOUSLY REMOVED, POST-OP, DUE TO INFECTION. LT IMPLANT BECAME INFECTED & REMOVED NOW.

BREAST IMPLANT MENTOR H/S Report # 144731
PT REQUIRED SURGICAL INTERVENTION TO REPLACE A DEFLATED SALINE BREAST IMPLANT.

BREAST IMPLANT MENTOR H/S Report # 327755
MENTOR BREAST IMPLANT CAT NO 350-1720T LOT 130112 WAS IMPLANTED IN RPTR BUT IN JUNE OF THIS YEAR IT WAS DIAGNOSED AS RUPTURED AND MENTOR CO NO LONGER MAKES THIS MODEL ANY LONGER AND RPTR CAN NOT FIND OUT WHY. RPTR WAS TOLD BY THE DR THIS MODEL WAS VERY GOOD FOR HAVING A FAULTY VALVE BUT THEY REFUSE TO FULLY COVER REPLACEMENT. RPTR ASKS THEY CAN FIND INFO ON THIS PARTICULAR MODEL.

BREAST IMPLANT MENTOR H/S Report # 428113
REMOVAL AND REPLACEMENT OF RUPTURED LEFT BREAST IMPLANT.

BREAST IMPLANT MENTOR H/S Report # 448371
CAPSULAR CONTRACTURE OF LEFT BREAST.

BREAST IMPLANT MENTOR H/S Report # 435241
RPTR HAD THEIR FIRST BREAST AUGMENTATION IN 1991 AND A FURTHER AUGMENTATION IN 1992. THE COMPANY WAS EUROSILICONE. IN 1995 THE IMPLANT RUPTURED AND THEY HAD A MENTOR IMPLANT PUT IN AND THEY WERE TOLD THAT THIS IS RARE. RPTR DID NOT HAVE ANY COMPENSATION. THEN IN 1998 THE IMPLANT RUPTURED AGAIN, ONCE AGAIN THEY PUT IN MENTOR IMPLANTS AND THE DOCTOR ASSURED THEM THAT THIS IS RARE. AGAIN NO COMPENSATION WAS GIVEN. IN 2000 THEIR BREAST RUPTURED AGAIN AND ONCE AGAIN RPTR HAD MENTOR IMPLANTS PUT IN. THIS TIME THEY HAD COMPENSATION GIVEN. IT IS NOW 2002 AND RPTR'S MENTOR IMPLANTS HAVE RUPTURED AGAIN AND RPTR HAS JUST GONE THROUGH THE SURGERY TO HAVE THEM REMOVED. MENTOR IS WILLING TO PAY FOR THE WHOLE SURGERY BUT RPTR IS NOT TO DISCLOSE ANYTHING TO ANYONE ONCE THEY SIGN THEIR RELEASE FORM. RPTR FEELS THAT THEY HAVE LIED TO THE CONSUMERS AS TO THE SAFETY AND RELIABILITY OF THEIR PRODUCT. EACH SURGERY RPTR HAD WAS IN A NEW PLACE. IT HAS COST RPTR A LOT OF MONEY AS WELL AS TAKEN ITS TOLL ON THEM. THE DOCTORS KEPT TELLING RPTR THIS IS RARE AND THAT THEY SHOULD TRY JUST ONE MORE TIME. THIS TIME WHEN RPTR HAD A RUPTURE THEY WERE HAVING EFFECTS AS IF THEY HAD ASTHMA AND CHEST PAINS. ALSO THEIR SHOULDER EXPERIENCED PAIN ON THE SAME SIDE. AS TO THE SAFETY OF THE PRODUCT RPTR HAS THEIR DOUBTS.


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Source: Manufacturer and User Facility Device Experience Database - (MAUDE). MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. MAUDE is scheduled to be updated quarterly and the search page reflects the date of the most recent update. MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester. The data is updated on a quarterly basis. DISCLAIMER: Section 21 CFR 803.16 states that "A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event." In addition, some firms have submitted their own additional disclaimer statements. A file of those disclaimers will be placed on the web shortly.
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