Breast Implantation is the prosthesis which alters the size and shape of a woman’s breast.
** Before considering a breat implant, get a picture of the breasts.
** Compare the picture taken with ideal breasts picture to differentiate the normal from the abnormal size.
** Sports bra available in various materials can be tried out in front the mirror and so a suitable size is got.
** The selected bra size can be accounted and the size for implantation should be a little bigger to compensate with the clothing.
** Thus the result obtained after surgery might be effective.
** Consulting a Plastic surgeon before confirming the size is advisable.
** The size varies as per the manufacturer, hence checkout with the piece before processing.
Some important factors to consider include:
- Breast implants do not last forever. If you decide to get breast implants, you will likely need additional surgeries on your breasts over your lifetime due to complications or unsatisfactory cosmetic outcomes.
- Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implants removed and not replaced, your breasts will not change back to the way they looked before your implant surgery. You may have permanent dimpling, puckering, wrinkling, or other cosmetic changes.
- When you have your implants replaced (revision), your risk of complications increases compared to your first (primary) surgery.
- Routine mammograms to screen for breast cancer will be more difficult with breast implants.
- Breast implants may affect your ability to breast feed, either by reducing or eliminating milk production.
Factors to consider specifically about silicone gel-filled breast implants include:
- If your silicone gel-filled breast implant ruptures, you may have no symptoms. This is called a silent rupture because, most of the time, neither you nor your doctor will know that your implant has ruptured.
- The best way to determine whether or not your silicone gel-filled implant has ruptured is with an MRI examination. You should have your first MRI three years after your implant surgery and every two years thereafter.
- Over your lifetime, the cost of MRI screening may exceed the cost of your initial surgery. This cost may not be covered by medical insurance.
Source: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063719.htm#1
Platinum is a metal used in the manufacture of the shell and gel components of silicone breast implants. FDA fully evaluated the scientific literature on platinum. Based on the existing literature, FDA believes that the platinum contained in the implant shell and gel is in the zero oxidation state, which poses the lowest health risk. This is further supported by the available biocompatibility testing, gel bleed testing, and clinical data on these implants.
Source: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063719.htm#1
The three types of saline-filled breast implants are as follows:
- One type is a single lumen implant that is filled during the operation with a fixed volume of saline through a valve. There are no adjustments of the saline volume after the operation.
- A second type is a single lumen implant that is filled during the operation with saline through a valve. This type of implant allows for adjustments of the saline volume after the operation.
- A third type is a single lumen implant that is prefilled by the manufacturer with a fixed volume of saline. There are no valves for filling during the operation or for adjustments of the saline volume after the operation.
The silicone rubber shell for a saline-filled breast implant has the following general composition:
- cured polymeric (large) silicones
- approximately 20% of finely powdered silica that is tightly bound to the silicone polymers
- small amounts of smaller silicones
- minute amounts (parts per million) of metals, including a metal catalyst (usually tin, zinc, or platinum) (A catalyst is something that causes a change in material.)
- traces of readily evaporating materials (volatiles), such as xylene and other organic compounds.
The filler is sterile saline that should conform to United States Pharmacopeia (USP) standards for Normal Physiological Saline (injection grade).
Source: FDA
Breast implants may vary in shell surface (smooth versus textured), shape (round or shaped), profile (how far it sticks out), volume (size), and shell thickness. The primary parts of most breast implants are a shell (otherwise known as the envelope or lumen), a filler, and a patch to cover the manufacturing hole.
With respect to the shell design, while most breast implants are single lumen (just the shell), some breast implants are double lumen (one shell inside another shell). With respect to the filler, some breast implants are manufactured with a fixed volume of filler, some are filled during the operation, and some allow for adjustments of the filler volume after the operation.
It should be noted that tissue expanders, which are silicone shells filled with saline, are regulated by FDA in a different way than breast implants. This is because tissue expanders are intended for general tissue expansion for a maximum of 6 months, after which, they are to be removed. Because of this, the design specifications (e.g., thinner shell) and preclinical testing recommendations are different for tissue expanders than for breast implants. Tissue expanders are not to be confused with the third type of double lumen silicone gel-filled breast implants described in the Silicone Gel-Filled Breast Implants section below. The third type of double lumen silicone gel-filled breast implant is a permanent implant (not intended to be removed) that allows for limited tissue expansion but is regulated by FDA as a breast implant.
Source: FDA
Breast implants do not last forever. If you decide to get breast implants, you will likely need additional surgeries on your breasts over your lifetime due to rupture, other complications (for example, capsular contracture, breast pain), or unacceptable cosmetic outcomes (for example, asymmetry, unsatisfactory style/size, wrinkling/rippling).
Source: http://www.fda.gov/
Information about participation in a clinical study can be obtained from the companies conducting the study. See the company contact information at http://www.fda.gov/cdrh/breastimplants/addsources.html.
Source: U.S. Deparment of Health and Human Services
There are several ongoing clinical studies (i.e., investigational device exemption (IDE) applications) of saline and silicone gel-filled breast implants. These studies include those for the more cohesive silicone gel-filled breast implants manufactured by Mentor and Allergan (formerly Inamed), as well as studies conducted by other manufacturers. These devices are still in research and have not been approved for marketing.
In addition, Mentor and Allergan will are conduct studies on patients who get silicone gel-filled breast implants after they are approved.
Source: U.S. Department of Health and Human Services
FDA approved saline-filled breast implants for augmentation in women ages 18 and older. FDA approved silicone gel-filled implants for women ages 22 and older. The age restrictions are different because the risks are different for the two products. For example, silicone gel-filled implants will require frequent MRI monitoring to detect silent rupture (a rupture that can go undetected by you or your doctor). There is no risk of silent rupture for saline-filled implants. In addition, the health consequences of a ruptured saline-filled breast implant are different from those of a ruptured silicone gel-filled breast implant.
Source: U.S. Department of Health and Human Services
Mentor and Allergan (formerly Inamed) saline-filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and (2) augmentation (primary augmentation and revision-augmentation) in women 18 years or older.
Mentor and Allergan silicone gel-filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and (2) augmentation (primary augmentation and revision-augmentation) in women 22 years or older.
FDA restricts the marketing of breast implants for augmentation to women of a minium age because young women’s breasts continue to develop through their late teens and early 20s and because there is a concern that young women may not be mature enough to make an informed decision about the potential risks. However, there is there is no age restriction on the marketing of these products for reconstruction, so as to allow young women to have access to breast implants to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality.
As for devices that are not approved for marketing, there are various age criteria and other restrictions for women who receive breast implants as part of a clinical study. Contact one of the companies conducting a study for more information. See the company contact information at http://www.fda.gov/cdrh/breastimplants/addsources.html.
Source: U.S Department of Health and Human Services
Comments (0) 
