Implant Specifications - Poly Implant Prosthesis
- Saline Breast Implant
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
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
The FDA has taken these implants off of the
market and the pre-filled saline implants are no longer made as of May 2000
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:
uncertainty over the
metabolic fate of the filling material
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
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.