Breast Implants Talk

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

If your saline-filled breast implant ruptures, you or your doctor will be able to tell. When saline-filled breast implants rupture, they deflate and the saline solution leaks into your body immediately or over a period of days. You will notice that your implant loses its original size or shape.

If your silicone gel-filled breast implant ruptures, it is likely that neither you nor your doctor will know. This is known as a silent rupture. This is why MRI is recommended at three years after implantation and then every two years thereafter to screen for rupture. However, sometimes there are symptoms. These symptoms include hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening of the breast.

Source: http://www.fda.gov/

We do not know all of the causes of breast implant rupture. We do know that breast implants can rupture from:

• damage during implantation or during other surgical procedures
• folding or wrinkling of the implant shell
• trauma or other excessive force to the chest
• compression of the breast during mammography.

Source: http://www.fda.gov/

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)

You may need non-surgical treatments or reoperations (including removal of your implant) to treat any of these local complications. Potential local complications include, but are not limited to:

. Asymmetry
. Inflammation/irritation
. Breast pain
. Malposition/displacement
. Breast tissue atrophy
. Necrosis
. Calcification/calcium deposits
. Nipple/breast sensation changes
. Capsular contracture
. Palpability/visibility
. Chest wall deformity
. Ptosis
. Delayed wound healing
. Redness/bruising
. Extrusion
. Rupture/deflation
. Galactorrhea
. Scarring
. Granuloma
. Seroma
. Hematoma
. Unsatisfactory style/size
. Iatrogenic injury/damage
. Wrinkling/rippling
. Infection, including Toxic Shock Syndrome

Source: FDA Breast Implant Consumer Handbook – 2004

• Breast implants will not last a lifetime. Either because of rupture or other complications, you will likely need to have the implants removed.

• You are likely to need additional doctor visits and reoperations because of one or more complications over the course of your life.

• You are likely to have the implants removed, with or without replacement, because of one or more complications over the course of your life.

• Many of the changes to your breast following implantation may be cosmetically undesirable, as well as irreversible (cannot be undone).

• If you later choose to have your implants removed, you may experience unacceptable dimpling, puckering, wrinkling, loss of breast tissue, or other undesirable cosmetic changes of the breast.

Source: FDA Breast Implant Consumer Handbook

Some of the risks of breast implants include:

• reoperations (additional surgeries), with or without removal of the device
• capsular contracture (hardening of the area around the implant)
• breast pain
• changes in nipple and breast sensation
• rupture with deflation for saline-filled implants
• rupture with or without symptoms for silicone gel-filled implants
• migration of silicone gel for silicone gel-filled breast implants.

Source: Center for Devices and Radiological Health

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