Breast Reconstruction Procedures
In a two-stage implant reconstruction, the first operation involves placement of the tissue expander by the plastic surgeon either at the time of your mastectomy or anytime thereafter. The plastic surgeon will use the same incision that was used for the mastectomy (in general, no additional scars will be created). The tissue expander is placed underneath your pectoralis muscle and chest skin. A small amount of fluid may be added at the time of expander placement. This stage of reconstruction can involve a short hospitalization or may be performed as an outpatient surgery. Over the course of months, fluid is gradually added to the expander in your doctor’s office. As the expander is inflated, the over-lying breast skin is stretched and breast shape is returned. After expansion has been completed, the tissue expander will be replaced with a permanent implant. This operation occurs in an operating room and usually is a short outpatient procedure. The same incision used for your mastectomy will be used for this procedure. Once anesthesia has taken effect, your plastic surgeon will make an incision to access the pocket created by the tissue expander, and the expander will be removed. Your selected breast implant will be placed in the pocket and positioned for optimal appearance and symmetry. After implant placement, your surgeon will close the incision – usually with stitches, although tape or glue may also be used.
One-stage implant reconstruction may also be a possibility if you are a candidate for immediate breast reconstruction. In a one-stage immediate reconstruction, your plastic surgeon will place the implant underneath the breast skin after the general surgeon removes the cancerous breast tissue. Or your plastic surgeon may suggest using a dual function implant that is a combination tissue expander/breast implant. This dual function implant is filled with little to no volume initially. Fluid is then gradually added in a simple office procedure after your surgery - similar to with the process of filling a tissue expander. Once your desired breast size is achieved, the mechanism used to fill the implant is removed in the office. The dual function device ultimately serves as your permanent implant, avoiding any need for an additional operation to exchange the expander for the permanent implant.
Breast reconstruction performed at the time of the mastectomy often requires a short overnight stay at the hospital, although you and your surgeon may choose to have the procedure done on an outpatient basis. Subsequent operatives are typically performed as outpatient procedures in a hospital operating room, surgery center, or surgical suite in a plastic surgeon’s office. However - depending on individual factors - you and your surgeon may choose an approach that requires an overnight stay at the hospital.
Although every case is different, on average, the surgery lasts one to two hours.
General anesthesia is most common. You and your surgeon will discuss the best anesthesia for you.
Every case is different, but many patients are able to resume normal activities within a few days. It’s best to avoid any strenuous activities that could raise your pulse and blood pressure for a couple of weeks.
You could wear a prosthesis or choose to accept your breasts as they are, post-mastectomy.
The breast consists of milk ducts and glands, surrounded by fatty tissue that provides its shape and feel. Situated beneath the breast is the pectoralis major muscle or chest muscle. Factors which may combine to stretch the skin and cause the breast to droop or sag include pregnancy (when milk glands are temporarily enlarged), rapid weight loss, and the effects of gravity as you age.
Breast implant cc volumes do not accurately translate to bra cup sizes.
Silicone is derived from silicon, a semi-metallic or metal-like element that, in nature, combines with oxygen to form silicon dioxide, or silica. Beach sand, crystals, and quartz are silica, which is the most common substance on earth. Heating silica with carbon at a high temperature can produce silicon. Further processing can convert the silicon into a long chemical chain, or polymer, called silicone - which can be a liquid, a gel, or a rubbery substance. Various silicones are used in lubricants and oils, as well as in silicone rubber. Silicone can be found in many common consumer items, such as suntan and hand lotion, antiperspirants, soaps, processed foods, waterproof coatings, and chewing gum.
The Institute of Medicine concluded that:
"There is no evidence that silicone implants are responsible for any major diseases
of the whole body. Women are exposed to silicone constantly in their daily lives."1
1 Institute of Medicine, National Academy of Sciences 2000. Information for women about safety of silicone breast implants (full article www.iom.edu).
MENTOR® MemoryGel® Breast Implants have been trusted and in use worldwide for more than 20 years. MENTOR® MemoryGel® Breast Implants feature a cohesive, gelatin-like silicone substance that acts as a solid rather than a liquid. It holds together uniformly while still retaining the natural give of breast tissue.
Gel cohesiveness is determined by the amount of cross-linking there is within the silicone gel filler: the more cross-linking, the more cohesive the gel and the more it acts as a solid rather than a liquid to maintain its shape. As such, highly cohesive silicone gel breast implants are able to retain their molded, teardrop shape.
The reference or catalog number tells what style and size of implants you have. The lot number tells when it was made. This information is very important should you need to have your implants replaced. Any surgeon, even many years from now, can use these numbers to find out exactly what kind of implants you have and what the best replacement will be. The numbers are also vital in the event of a deflation or rupture to help process your replacement policy and limited warranties.
No. Mentor does not use latex in any of its implantable devices. These include tissue expanders, saline volume sizers, saline-filled breast implants and silicone gel-filled breast implants. Latex gloves are not allowed on the floor during the manufacturing process. At no time during the manufacturing process is latex or talc-containing material utilized. (Natural latex contains proteins which may cause allergic reaction in some individuals.)
Breast implants come in a variety of shapes, surface textures, and sizes. The implants are available with a textured or smooth surface shell. MENTOR® Breast Implants come in either round or contoured shapes.
Contraindications for breast implants include women who are currently pregnant or nursing, have an existing malignant or pre-malignant cancer of their breast without adequate treatment, or have an active infection anywhere in their body. Your surgeon is the best resource with whom to discuss your eligibility for breast reconstruction with breast implants.
General Resources About Implants:
The Mentor “Informed Decision” product brochures for both saline and gel implants are available on our website. You can request a copy from your surgeon or from Mentor. For more detailed information on the preclinical and clinical studies conducted by Mentor, please go to the Summary of Safety and Effectiveness Data for this product at www.fda.gov. You will be given a device identification card with the style and serial number of your breast implant(s).
Mentor Worldwide LLC
www.mentorwwllc.com
Institute of Medicine Statement on the Safety of Silicone Implants
www.nap.edu/catalog/9618.aspxl
Food and Drug Administration
1-888-INFO-FDA or 301-827-3990
http://www.fda.gov/cdrh/breastimplants/
To view the full Patient Reconstruction brochure click here.
Women with breast implants undergo mammography and other imaging techniques just as do women without implants. You may wish to undergo a pre-operative mammogram and another one six months to 1 year after implantation to establish a baseline. With breast implants, routine screening mammography will be more difficult, and you will need to have additional views, which means more time and radiation. However, the benefit of the mammogram in finding cancer outweighs the risk of the additional x-rays. Breast implants may complicate the interpretation of mammographic images by obscuring underlying breast tissue and/or by compressing overlying tissue. Accredited mammography centers and use of displacement techniques are needed to adequately visualize breast tissue in the implanted breast. Women with breast implants must inform mammography technicians about the presence of their implants so that the technician can use special techniques to minimize the possibility of rupture and to get the best possible views of the breast tissue. Because the breast is squeezed during mammography, it is possible for an implant to rupture during the procedure.
Deposits of calcium can be seen on mammograms and can be mistaken for possible cancer, resulting in additional surgery to biopsy and/or removal of the implant to distinguish them from cancer.
There has been no clinical evidence to suggest that breast reconstruction with or without an implant interferes with breast cancer surveillance. Furthermore, there is no evidence to suggest that reconstruction increases the chance that the breast cancer will return.
It is possible for anyone to develop an allergy to almost any substance on earth, however silicone allergies are very rare. We are all exposed to silicone in our environment every day. It is found in many consumer items, such as polishes, suntan and hand lotion, antiperspirants, soaps, processed foods, waterproof coatings, and chewing gum.
As a natural reaction to any device placed in the body, scar tissue will form around the breast implant surface creating a capsule.
Mentor is monitoring the long-term (ie, 10- year) chance of implant rupture, re-operation, implant removal, and capsular contracture. Mentor is also conducting mechanical testing to assess the long-term likelihood of implant rupture.
For important information on the benefits and risks associated with silicone breast implant surgery, read our document called "Important Information for Augmentation Patients about MENTOR® MemoryGel® Silicone Gel-Filled Breast Implants."
Safety and effectiveness have not been established in patients with the following conditions:
- Autoimmune diseases such as lupus and scleroderma
- Conditions that interfere with wound healing (such as poorly controlled diabetes) and blood clotting (such as concurrent Coumadin therapy)
- A compromised immune system (eg, currently receiving immunosuppressive therapy)
- Reduced blood supply to breast tissue
Concern over the association of breast implants to the development of autoimmune or connective tissue diseases, such as lupus, scleroderma, or rheumatoid arthritis, was raised because of cases reported in the literature with small numbers of women with implants. A review of several large epidemiological studies of women with and without implants indicates that these diseases are no more common in women with implants than those women without implants.
Published studies indicated that breast cancer is no more common in women with implants that those without implants.
If you experience any problems, contact your health care professional.
With breast implants that are too large for the amount of breast tissue you have, the implants’ edges may be visible through your skin or the implant may be more easily felt after your operation. You also may increase the risk of having surgical complications. Plus, breast implants that are too large may increase the effects of gravity on your body, causing your breasts to prematurely droop or sag.
Reports in medical literature indicate patients with breast implants are not at a greater risk than those without breast implants for developing breast cancer.
Mentor has not tested the in vivo effects of radiation therapy in patients who have breast implants. The literature suggests that radiation therapy may increase the likelihood of capsular contracture, necrosis, and extrusion.
The scar tissue or capsule that normally forms around the implant may tighten and squeeze the implant and is called capsular contracture. Capsular contracture is more common following infection, hematoma, and seroma. It is also more common with sub-glandular placement. Symptoms range from firmness and mild discomfort, to pain, distortion, palpability of the implant, and/or displacement of the implant. Additional surgery is needed in cases where pain and/or firmness is severe. This surgery ranges from removal of the implant capsule tissue to removal and possibly replacement of the implant itself. Capsular contracture may happen again after these additional surgeries. You should be aware that closed capsulotomy, the practice of forcible squeezing or pressing on the fibrous capsule around the implant to break the scar capsule, is not recommended, as this may result in breakage of the implant.
Saline breast implants deflate when the saline solution leaks either through an unsealed or damaged valve, or through a break in the implant shell. Implant deflation can occur immediately or progressively over a period of days and is noticed by loss of size or shape of the implant. Some implants deflate in the first few months after being implanted and some deflate after several years. Causes of deflation include damage by surgical instruments during surgery, overfilling or under-filling of the implant with saline solution, capsular contracture, closed capsulotomy, stresses such as trauma or intense physical manipulation, excessive compression during mammographic imaging, umbilical incision placement, and unknown/unexplained reasons. You should also be aware that the breast implant may wear out over time and deflate/rupture. Deflated implants necessitate additional surgery to remove and to possibly replace the implant.
Feeling in the nipple and breast can increase or decrease after implant surgery. The range of changes varies from intense sensitivity to no feeling in the nipple or breast following surgery. Changes in feeling can be temporary or permanent and may affect sexual response or the ability to nurse a baby.
This depends upon multiple factors, such as the type of implant you receive, the way your body holds the implant and whether or not there is any degree of capsular contracture. It is possible for many women to have breast implants that are soft and move nicely, while other women have results that are firmer with an implant more fixed in position.
Insertion of implants can cause stretch marks but rarely does. If you are concerned, go for a smaller size implant to minimize the stretching of the skin, or choose a SPECTRUM™ Post-Operatively Adjustable Saline Breast Implant to slowly stretch the skin over time.
Smoking causes the blood vessels to constrict, reducing the blood supply and the oxygen carried by the blood to the surgical area. The tissues need this blood supply and the oxygen that the blood carries in order to heal. When the blood supply is reduced, the tissues heal more slowly. Different doctors have different time frames for patients to refrain from smoking before and after surgery. We hear anything from five weeks prior and after, to one to two weeks prior and after. Ask your doctor how long he/she would like you to stop smoking before and after your surgery.
Your doctor will be your best guide regarding how long you will need to remain off work and will advise you when and how to resume activities. Recovery periods vary from woman to woman. Generally the first few days are the most uncomfortable. The average time to return to full activities is four to six weeks.
It is important not to sweat into the incision while it is healing. Therefore, curtail activity and sun tanning until after the incision is healed and sealed. Don’t over-do activity, especially of the upper body, too early. Let your body rest and heal. You want to minimize swelling around the implant.
Going into a Jacuzzi or bath after a month is usually ok. During the early time, one to two weeks following surgery, you don’t want to soak the incision.
Be sure you check with your doctor before returning to your workouts. Patients vary greatly in recovery times. Walking is generally recommended to encourage circulation. The larger the implant you receive the heavier the breasts will be. You should wear good support bras while running to minimize pull on the skin and ptosis (drooping) of the breast.
Tanning at salons or sun bathing will not hurt the implant but may make the scars worse. You should avoid getting sun or tanning rays on the incisions for at least one year after surgery as tanning rays will turn the incisions dark permanently. The implant may feel warm and may take longer to cool down than your body.
Many women scuba dive and fly in airplanes with implants. There may be slight expansion and contraction of the shell with changes in pressure. This may result in a small amount of air bubbles in the implant. With saline filled breast implants, you may feel or hear fluid sounds (gurgling). This should correct itself within 24-48 hours.
Most doctors ask that women wait 3 months before wearing under wire bras after implant surgery. Your body will be forming scar tissue around the implant for 3 months. During this time the pressure of the wires could cause the scar tissue to form in such a way that an indentation from the wires could become permanent. After this initial healing time under wire bras should be worn intermittently to avoid permanent indentation.