Breast Implants Talk

As younger and younger women are considering breast implants. We get many questions such as the age limit. The FDA has the following age limits:

• You need to be 22 in order to have silicone gel-filled breast implants
• You need to be 18 to get saline-filled breast implants for augmentation

However, these are required by the FDA, it doesn’t mean that you should consider them at such young age. There are, many risks associated with breast implants. You could experience breast pain, changes in nipples, and even rupture with deflation for saline-filled implants.

Source: FDA

The age of women who want  breast implants is getting younger and younger. Many child bearing age women or mothers who just had babies are considering them. Before you talk to any doctor, be sure you do enough research to find out the pros and cons, the risks of breast implants.

To start, breast implants are medical devices that are implanted either under your breast tissue or under the chest muscle for breast augmentation or reconstruction. If you are still in child bearing age, talk to the doctor about feature breastfeeding problems that might occur. No matter what kind of ads you hear or see, make sure they’re approved by the FDA. Currently there are only two major types of implants: saline-filled and silicone gel-filled.

Well, we all hear that a lot in the media. Women of all ages now are talking about breast implants. Girls as young as 18 are considering getting breast implants. But what is it exactly? If you know how it’s done, you probably will think twice about getting one. Keep in mind, breast implants are medical devices. They are not manicure or pedicure. The surgeon implants a special material either under your breast tissue or under the chest muscle for breast augmentation or reconstruction.

There are mainly two major types: saline-filled and silicone gel-filled. You might hear or read somewhere that new stuff is coming to the market. Be aware of these commercials. Because there are only two kinds of materials that are approved by the FDA: saline-filled and silicone gel-filled.

Saline-filled breast implants are silicone shells that are either pre-filled or filled with saline during surgery, and some of these allow for adjustments of the filler volume after surgery. Silicone gel-filled breast implants are silicone shells pre-filled with silicone gel. Breast implants vary in profile, size, and shell surface. You might wonder that shell surface is. It means smooth or textured surface. No one knows how would anyone prefer textured surface. But that what it is.

Source: FDA

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

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/

it is likely that you will need to have one or more reoperations over the course of your life because of local complications from breast implants.

Reasons for reoperations could include any of the potential local complications bulleted above, such as capsular contracture, wrinkling, asymmetry, rupture/deflation, implant malposition, etc.

The type of surgical procedure(s) performed during the reoperation depends on the local complication involved. More than one procedure may be performed in a single reoperation. Examples of the types of surgical procedures that may be performed in a reoperation include:

• implant removal with or without replacement

• capsule procedure (e.g., removal or surgical release of the capsule)

• scar or wound revision (e.g., surgical removal of excess scar tissue)

• drainage of a hematoma (e.g., inserting a needle or tube through the skin to drain the collection of blood)

• repositioning of the implant (e.g., surgically opening the incision and moving the implant)

• biopsy/cyst removal (e.g., inserting a needle through the skin or cutting through the skin to remove a lump).

Multiple reoperations to either improve the appearance of the breasts, to remove ruptured/deflated implants, or both may result in an unsatisfactory cosmetic outcome.

A retrospective study by Gabriel, et al. showed that 24% of women with breast implants had complications resulting in a reoperation during the first five years after implantation (silicone and saline implants were studied together). ⁷ According to this study, about 1 in 3 women getting breast implants for reconstruction needed a reoperation within five years, and about 1 in 8 women getting breast implants for augmentation needed a reoperation within five years.

Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed reoperation rates of 13-21% at 3 years and 20-26% at 5 years for augmentation patients. The same studies showed reoperation rates of 39-40% at 3 years and 43-45% at 5 years for reconstruction patients.

Source: The U.S. Food and Drug Administration (FDA)

Breast implants are used for:

• primary augmentation (to increase breast size for cosmetic reasons)
• revision-augmentation ( revision surgery to correct or improve the result of an original breast augmentation surgery)
• primary reconstruction (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)
• revision-reconstruction ( revision surgery to correct or improve the result of an original breast reconstruction surgery).

Source: Center for Devices and Radiological Health

FDA has approved four breast implants for marketing in the U.S.:

• In May 2000, Mentor and Allergan (formerly Inamed) received approval for saline-filled breast implants. These implants were approved for breast augmentation in women 18 years or older and for breast reconstruction in women of any age.

• In November 2006, Allergan and Mentor received approval for their silicone gel-filled breast implants. These implants were approved for breast augmentation in women 22 years or older and for breast reconstruction in women of any age.

All breast implants other than these four approved devices are considered investigational devices, including the more-cohesive (“gummy bear”) implants. For a woman to receive an investigational breast implant in the U.S., she must enroll in a clinical study.

Source: Center for Devices and Radiological Health