-
uncertainty over the metabolic fate of the filling material
-
pathological changes suggesting a systemic effect in rats following implantation of the filling material. No long-term toxicity data are available to allow an assessment of the significance or reversibility of these effects.
|
|
PIP Breast Implant Specifications - Poly Implant Prosthesis
PIP Breast Implants are pre-filled saline implants. These implants have no valve for filling, so the theory was that these implants had less of a chance of leaking. Another benefit was that there was no valve to be felt. Because of the factor that these implants have no valve, these implants had the ability of keeping a consistent volume without bubble formation. The implant shell that was utilized by PIP is made of a material known as elastomer. This particular type of elastomer was used by other implant companies years ago but was abandoned due to a high failure rate. The FDA required all implant manufacturers to submit a Pre-Market Approval application in order to make a determination as to what implants were proven safe and effective for continued sale. The FDA Panel did not recommend approval of PIP implants due to the fact that the clinical study submitted by PIP did not have a sufficient number of patients with two years post-surgery. The FDA has taken these implants off of the market and the pre-filled saline implants are no longer made as of May 2000
PIP Hydrogel breast implants have a silicone elastomer shell and are filled with a hydroxypropyl cellulose hydrogel (polysaccharide) gel. The adverse incident reports of breast swelling associated with the presence of fluid in the implant pocket around the PIP Hydrogel breast implants was a cause for concern with their safety. Hydrogel spreads out in tissues with swelling and edema after rupture of an implant. Because of this, there has been a voluntary recall of PIP Hydrogel breast implants. These implants are no longer made. The concerns with PIP Hydrogel Breast Implants were:
Hydrogel Breast Implants are no longer available
The PIP silicone implant was designed to ensure optimum safety with a very strong elastomer shell which had an integral textured surface which helped reduce capsular contracture rates. The silicone gel was highly cohesive and was very soft in that it resembled natural breast tissue. PIP claimed their silicone gel implant would not leech away from the shell even when cut in half. These implants were not used in the United States because of the timing of the moratorium on silicone implants.
|
