Table 4.
Prescan Survey*
| Question | No. (%) |
|---|---|
| 1. Have you been concerned that you may have a ruptured implant? | |
| No, I have never been concerned that I have a ruptured implant. | 414 (70.9) |
| Yes, I have been concerned that I have a ruptured implant only within the past year. | 130 (22.3) |
| Yes, I have been concerned that I have a ruptured implant for longer than the past year. | 40 (6.8) |
| 2. Did you know the FDA recommends an MRI scan to screen for silent rupture of silicone gel implants after 3 years and then every 2 years for life | |
| Yes | 139 (23.8) |
| No | 445 (76.2) |
| 3. Have you had an MRI scan to screen for silent rupture of your silicone gel implants? | |
| No, I never have had an MRI scan to screen for silent rupture of my implants. | 557 (95.4) |
| Yes, I have had only 1 MRI scan since receiving my implants. | 21 (3.6) |
| Yes, I have had 2 MRI scans since receiving my implants. | 2 (0.3) |
| Yes, I have had 3 or more MRI scans since receiving my implants. | 4 (0.7) |
| 4. Would you like to know if you have a ruptured implant? | |
| Yes | 581 (99.5) |
| No | 3 (0.5) |
| 5. If you learn an implant has a rupture, which of the statements below would apply to you? (check all that apply) | |
| I would be concerned that I didn’t know the implant was ruptured. | 370 (63.4) |
| I would be concerned about how long the implant had been ruptured. | 402 (68.8) |
| I would be concerned about silicone gel coming in contact with my body tissue. | 449 (76.9) |
| I would be concerned about the time, cost, or extent of surgery needed for revision. | 426 (72.9) |
| I would be concerned about other potential complications. | 422 (72.3) |
| Nothing would concern me. | 10 (1.7) |
| 6. If you learn an implant has a silent rupture but you do not have symptoms, would you like to have it removed? | |
| Yes | 556 (95.2) |
| No | 28 (4.8) |
| 7. If you those to remove your ruptured implant, what course of action would you take? (check all options you would consider) | |
| Replace the implant with another silicone gel implant, only if the costs are reduced by warranty. | 286 (49.0) |
| Replace the implant with another silicone gel implant, even if the costs are out-of-pocket. | 293 (50.2) |
| Replace the implant with an alternative to silicone gel implants (structured implant or saline implant), even if the costs are out-of-pocket. | 200 (34.2) |
| I would not replace the implant. | 99 (16.9) |
FDA, U.S. Food and Drug Administration; MRI, magnetic resonance imaging.
*
n = 584.