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Breast
Augmentation Risks & Complications
Most
complications of surgery and risks can be avoided by finding a good plastic
surgeon.
FDA & Implants - Complication Rate - Product
Summary
Surgical Permit - Other Risks
- Silicone Implants
FDA
Approves Silicone Implants
10/15/03 - After 16 hours of testimony and debate from over 100 women,
plastic surgeons and consumer advocates the FDA government panel voted
9-6 to approve silicone breast implants for implant manufacturer,
Inamed (formerly McGhan).
The
panel stressed women will need yearly mammograms to check for signs
of leakage since silicone can leak without immediate knowledge to
the patient because the silicone leaks out slowly (whereas saline
implants will deflate fairly quickly). If there is leakage or a break
in the implant, the implant(s) should be replaced.
The
panel also advised Inamed to follow patients for 10 years after implants,
thus, all implant recipients will be enrolled in a registry to track
their health. Inamed will continue to track the health of patients
in its current study for another seven years, as they already have
3 years of research of these patients.
FDA
Approves Saline Breast Implants
May
10, 2000: FDA has approved saline breast implants. U.S. health officials
said saline-filled breast implants made by Inamed (formerly McGhan)
and Mentor, the two leading maker/s of the products, are safe and
effective for continued use. Other companies that make implants that
do not hold FDA approval must stop distributing the products after
May 15, 2000. Click
here to see story at the APRS web site.
My
surgery was before the FDA approval. I had to sign a "Product
Summary" for the saline implants, as well as a "permit"
for the doctor. Both of which described possible risks, summarized
here. Most of these complications require additional surgery, and
your surgeon may charge you for any additional surgery.
Complication
Rate
The
Danish Registry for Plastic Surgery of the Breast registered 1,240
women who received breast implants for the first from June 1999 to
November 2001 and shows that a low number of silicone and saline implant
recipients experience complications.
85%
received breast implants for augmentation and 15% had breast reconstruction
following mastectomy; 88% were silicone gel.
16%
experienced complications (the majority of which was change in feeling)
4%
(of the 16%) had capsular contracture, the majority of which were
categorized as minor; and 1% (of the 16%) required additional surgery.
Product
Summary, Saline Implants
Silicone Implant Reports and Studies Here
Condensd
Product Summary for Saline Filled Implants indicates the following:
MOST COMMON
RISKS:
1. Deflation
(aka Rupture)
2. Making
Breast Cancer Harder to Find
3. Capsular
Contracture (Hardness and/or pain due to the tightening of scar tissue).
Rebecca's note: I see this to be most common with overs and more common
with smooth implants.
OTHER KNOWN
RISKS:
1. Calcium
Deposits (occasionally, these need to be removed surgically)
2. Additional
Surgeries (there is a fairly high chance for the need to replace or
remove the implant)
3. Infection
(implant may need to be removed)
4. Hematoma
(collection of blood that may need to be drained surgically)
5. Delayed
wound healing (in rare instances, the implant could push out through
the skin)
6. Changes
in feeling in the nipple and breast (increased or decreased, temporary
or permanent, may effect nursing)
7. Shifting
of the implant.
UNKNOWN
RISKS:
AUTOIMMUNE
DISEASES: According to scientific studies, women with breast implants,
in general, are not at an increased risk for autoimmune or connective
tissue diseases. Studies have been too small to indicate increased risk
in of any rare disease. Some reported symptoms have been: Swelling and/or
joint pain or arthritis-like pain, general aching, unusual hair loss,
unexplained or unusual loss of energy, greater chance of getting colds,
viruses and flu, swollen glands or lymph nodes, rash, memory problems,
headaches, muscle weakness or burning, nausea, vomiting, and Irritable
Bowel Syndrome.
BREAST
FEEDING: There is limited research.
Surgical
Permit, Saline Implants
(Summarized)
The following
are complications and the frequency varies from person to person and
procedure to procedure. Many of the complications were repeated on this
form, so I left out those that were previously stated above.
1. Bleeding
(may require additional surgery and/or transfusion)
2. Neuroma
(temporary or permanent painful areas in the breast, may require additional
surgery)
3. Excess
Scarring (thicker, wider, longer, different in complexion, or painful).
4. Asymmetry
of Breasts (size and shape may change).
5. Sagging
of the Breasts.
6. Allergies
or unexpected responses to anesthetic agents, medications, skin preparations,
or dressings used.
7. Other
complications which are not listed.
8. Severe
and unusual complications rarely occur that may place the patient's
health and life in jeopardy.
The following
should also be recognized:
A. Saline
implants have a silicone shell, the concern with these is less than
with the gel-filled implants.
B. Pain
and discomfort.
C. Loss
of time from work and other activities.
D. All
surgical procedures produce scars, and that these will be permanent.
E. Must
have a someone to drive you home and take care of you for at least 24
hours following surgery and possibly longer.
F. Must
not drive for at least 3 days.
G. Must
not take aspirin, Ibuprofen or high doses of Vitamin E for two weeks
prior to and two weeks after surgery (these drugs may cause bleeding).
Other
Risks
 Mondor's
Disease or Cord -- (pictured) Hardening or blood clot in a vein
leading away from the surface of the breast. This is a blocked vein
that it will go away in a month or two. If it is large or painful, you
can put a warm washcloth on the cord or to break up the matter that
is blocking the vein, massage the cord. Push on it and rub it and the
blockage will dissipate faster.
Copyright©1997-2008 All
About Breast Augmentation and Breast Implants Plastic Surgery Information. All
Rights Reserved
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SURGEONS:
Breast
Cancer