Cadaver Tissue Breast Reconstruction

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The use of cadaver tissue for breast reconstruction is a relatively new development in the world of plastic surgery. It’s an exciting alternative to implants that offers patients the chance to avoid some of the potential complications associated with traditional breast reconstruction procedures, such as capsular contracture and infection.

This article will explore alloderm lawsuit breast reconstruction, and new breast reconstruction techniques.

AlloDerm® Regenerative Tissue Matrix for Breast Reconstruction

Many women who undergo mastectomies opt for breast reconstruction. AlloDerm® Regenerative Tissue Matrix, which is manufactured by LifeCell, is frequently used during the reconstruction process. AlloDerm tissue can replace some of the breast tissue removed during surgery and provide support for implants.

It is created by taking tissue from a carefully screened donor (cadaver), and then putting the tissue through a cell-removal process that reduces the likelihood of rejection, yet leaves the basic tissue structure intact. Because it is produced from natural human tissue, it is not only well tolerated, but actually grows into the patient’s tissue for a strong, natural repair. The product is also used for some types of head and neck plastic-surgery reconstruction, and for hernia repair. According to its manufacturer, AlloDerm Regenerative Tissue Matrix has been used successfully in more than one million grafts and implants.

Breast reconstruction may be done in one step or two, with the two-step procedure used in the majority of cases.

Two-Step Procedure

In the two-step procedure, a new breast is created by first using a tissue expander, which is a temporary implant filled with saline. By periodically injecting more saline into the tissue expander, the skin stretches to create a soft pocket designed to hold a permanent implant. The tissue expander is put in place right after the breast is removed. To stabilize the tissue expander, it is placed under AlloDerm tissue, which is sewn from the pectoralis major muscle to the chest wall.

Breast skin then grows into the AlloDerm tissue, which forms an extra protective layer between the implant, when it is inserted, and the surface of the breast. The AlloDerm tissue is positioned to provide the correct shape and foundation for the implant.

In the second stage of the procedure, which takes place approximately 12 to 24 weeks after the skin is sufficiently expanded, the permanent implant is inserted.

Single-Step Procedure

In the single-step procedure, a breast is created at the time of removal. AlloDerm tissue is sewn to the chest muscle to provide a hammock-like support for the implant. The AlloDerm tissue is essentially making the chest-muscle space larger, allowing a permanent full-sized breast implant to be inserted without having to use a tissue expander. The single-step procedure works best for women with small to moderate-sized breasts and good-quality skin tissue, and who are having mastectomies when their cancer is in its early stages. Women having preventative mastectomies because they are at high risk for breast cancer are also good candidates.

Breast Reconstruction Using a Tissue Expander

This information explains how to care for yourself after your mastectomy with breast reconstruction using a tissue expander. It will also help you get ready for the tissue expansion process. A mastectomy is a surgery to remove your breast.

This information is meant to add to, not replace, discussions with your healthcare providers. Some of the information may not apply to you. Be sure to ask your plastic surgeon or nurse if you have any questions.

About Breast Reconstruction Using a Tissue Expander and Permanent Implant

A tissue expander is an empty breast implant. Your surgeon will place it during your mastectomy. The usual hospital stay after a mastectomy with breast reconstruction is less than 24 hours. That means you may go home the same day as your surgery.

Once your tissue expander is in place, your surgeon will fill it with liquid or air over about 6 to 8 weeks. As it gets bigger, it will stretch the tissue around it to make space for a permanent breast implant. For more information, read the section “What to Expect During Tissue Expansion.”

Your surgeon will stop filling your tissue expander when it reaches the breast size you agreed on. They’ll replace it with a permanent breast implant. For more information, read the section “After You Finish Your Tissue Expansion.”

Placing your tissue expander

There are 2 ways to place your tissue expander:

  • Submuscular placement is when your surgeon places the expander under your large pectoralis muscle in your chest. They will make a pocket under the muscle and place your tissue expander in that space.

    If your tissue expander is under your muscle, it will be filled with liquid. Your skin is very weak and fragile after your mastectomy. Your muscle is a barrier between your skin and the tissue expander. It helps take the pressure from the expander off your skin when it’s healing.
  • Prepectoral placement is when your surgeon places the expander over your large pectoralis muscle in your chest. They will also place a mesh called acellular dermal matrix around the expander. The mesh will help support the expander while your skin is healing. Over time, your body will absorb the mesh. It will not need to be removed.

    If your tissue expander is over your muscle, it may first be filled with air instead of liquid. Your skin is very weak and fragile after your mastectomy. Because air is less dense than water, it will put less pressure on your skin when it’s first healing. Your surgeon will replace the air in your tissue expander with liquid about 2 weeks after your surgery.

Your surgeon will talk with you about how your tissue expander will be placed during your presurgical consultation.

What to Expect After Your Mastectomy and Tissue Expander Placement Surgery

After your surgery, you’ll wake up in the Post-Anesthesia Care Unit (PACU) or recovery room. If your surgery is at the Josie Robertson Surgery Center (JRSC) you’ll wake up in your own room. You’ll have:

  • An intravenous (IV) line. You’ll get fluids, antibiotics, and pain medication through your IV.
  • Small plastic drains, called Jackson-Pratt® (JP) drains, below or near each incision (surgical cut). These collect fluid from around your incisions after surgery. They’ll be secured with a suture (stitch) and most often stay in place for 1 to 2 weeks after surgery.

Your PACU nurses will answer any questions you have.

JP drain(s)

Your nurses and nursing assistants will care for your JP drains while you’re in the hospital. Your nurses will teach you how to care for them at home. They’ll also give you the resource Caring for Your Jackson-Pratt Drain.

Your drains will be removed 1 to 2 weeks after your surgery.

Incisions

After your surgery, you’ll have a dressing (bandage) over your mastectomy incision. The dressing will have either plain gauze or gauze with clear tape. It will be held in place by a surgical bra.

The incision across your breast will be closed with sutures (stitches) placed inside your body. These sutures will dissolve and do not need to be removed. You may see some redness and slight bloodstains on the gauze pad over your incision. You may also feel tenderness and have some bruising around the incision. This is normal.

Right after your mastectomy, your reconstructed breast(s) may be smaller than your breast(s) were before surgery. This is because your tissue expander is only partly filled when it’s placed. Before you go home, look at and feel your breast and incision when your nurse is changing your dressing. This will help you become familiar with it. You may be able to feel the port that’s used to fill your tissue expander under your skin. This is normal.

Pain and sensations

You’ll have some discomfort after your surgery. You may have a stinging feeling along your incision. Your drain site(s) may itch. You may also feel some tenderness along your lower ribcage. These feelings will get better over time. You can take pain medication and a muscle relaxer when you need it, You’ll get these when you’re discharged from the hospital. Controlling your pain will help you recover better and become active as soon as possible.

Other common feelings you may have after your surgery are:

  • Numbness under your arm and over your chest on the affected side. Your affected side is the side of your surgery.
  • Warmth in your arm on the affected side.
  • A feeling of water trickling down your arm or chest on your affected side.

These are caused by nerves being cut or moved during your surgery. They’ll slowly get better over time, but some amount of numbness may be permanent.

Caring for Yourself at Home

When you leave the hospital, your incision will be covered with a gauze pad. It’s normal to see some staining on the gauze pad for 24 to 48 hours (1 to 2 days) after surgery. If you see drainage (liquid) coming from your incision, call your doctor’s office.

Wear your surgical bra 24 hours a day until your doctor gives you other instructions. Take it off when you shower.

Showering

Do not shower or get your dressing wet for the first 48 hours (2 days) after your surgery. After the first 48 hours, you may be able to take a full shower or shower from your waist down. Follow your surgeon’s instructions for how to shower. Some guidelines are listed below.

  • When you start showering, take a shower every day to help keep your incision clean.
  • Take off your surgical bra and the gauze pad over your incision before you get in the shower.
  • Check the temperature of the water first with your back or hand. Numbness may keep you from feeling heat in the affected area.
  • Wash with warm water and gentle, fragrance-free soap. Gently clean your incisions and drain sites. Rinse well.
  • Do not aim the shower stream at your reconstructed breast. Aim it at your upper back or your arm. Let the water run softly over your reconstructed breast.
  • Pat your incisions dry with a clean towel. Do not rub them.

Your healthcare provider will remove your drains 1 to 2 weeks after your surgery. Do not get your dressing wet for 24 to 48 hours (1 to 2 days) after your drains are removed. This includes taking a shower. Your surgeon will tell you how long to avoid getting it wet.

You can take a full shower 24 to 48 hours after your drains are removed. Follow your surgeon’s instructions.

Do not take tub baths until your incisions and drain sites are fully healed. Soaking in a tub may raise the risk of infection. You may be able to take tub baths about 6 to 8 weeks after your surgery. Talk with your doctor before you do.

Check your incisions and drain sites

After your shower, look at your incisions and drain site(s) carefully. To do this, stand in front of a mirror in a room with good lighting. Call your plastic surgeon or nurse if you have any of these:

  • A fever of 100.4 °F (38.0 °C) or higher
  • Increased redness of your breast
  • Increased swelling of your breast
  • New drainage from your incision
  • Bad bruising
  • More than 30 milliliters (mL) of bloody drainage in your JP drains per hour

When you finish checking your incisions and drain site, place a clean gauze pad over your incision. Put on your surgical bra.

Shaving

You can shave under your arms about 2 weeks after your surgery. Only use an electric razor on your affected side. This is to prevent getting a cut, which you may not feel due to numbness. A cut could lead to an infection.

Deodorant

Do not use deodorant until after you put your bra on. This will keep it from getting on your incision and causing an infection.

Do not use deodorant on your affected side if there is any break in the skin there.

First Follow-up Visit

Your first follow-up visit will be 1 to 2 weeks after your surgery. Your plastic surgeon’s nurse will call you after your surgery to see how you’re recovering. They’ll also schedule your follow-up visit.

During this visit, your plastic surgeon and nurse will check your breast incision to make sure it’s healing well. If you went home with a JP drain(s), your healthcare provider may remove one or more of them.

  • If your tissue expander(s) were placed below your muscle, your healthcare provider will remove your JP drain if it has less than 30 mL (1 fluid ounce) of drainage per day for 2 days in a row.
  • If your tissue expander(s) were placed above your muscle, you’ll likely have your JP drain(s) for at least 2 weeks. The amount of drainage does not make a difference.

Make sure to shower before this visit. You will not be able to shower again until after your drain site(s) heal. This is most often 24 to 48 hours (1 to 2 days) after your drain(s) are removed.

JP drain removal

Most people describe the drain removal as a slight pulling or stinging feeling that lasts only a few minutes. You will not need to take pain medication for the drain removal process.

After your drain(s) are removed, some liquid may still leak from the drain site(s). Cover the area with a sterile gauze pad or the Primapore™ dressing your nurse gave you. Change your gauze and dressing if they become damp. By that time, the drain sites are most often healed. Do not shower until your drain site are fully healed.

After the drain(s) is removed, keep wearing the surgical bra or your own supportive bra. It should:

  • Be comfortable.
  • Not be too tight.
  • Not have an underwire.

Your doctor may also have you place thick gauze pads over your drain sites for extra compression. This is to keep fluid from building up under your skin.

What to Expect During Your Tissue Expansions

During your second or third office visit, you’ll have your first tissue expansion.

  • If your tissue expander is under your muscle, your nurse will inject liquid into it through the port. They’ll use a small needle.
  • If your tissue expander is over your muscle and has air in it, your nurse will remove the air. They’ll replace the air with liquid.
  • If your tissue expander is over your muscle and has liquid in it, your nurse will add more.

You’ll have a tissue expansion visit about every week or every other week. The tissue expansion procedure only takes a few minutes. Your reconstructed breast will get bigger after each expansion. It will not take its final form until the permanent implant is placed.

How to be more comfortable between tissue expansions

After each expansion, you may feel some tightness and fullness in your breast. You may also have some discomfort in your shoulder or back. This most often gets better within a few days.

After your expansion your chest may be sore, like after you have exercised. Here are some things you can do to be more comfortable between tissue expansions:

  • Take a few warm showers a day to help relax your muscles.
  • Take over-the-counter pain medications (medication you buy without a prescription), such as acetaminophen (Tylenol®) or ibuprofen (Advil®).
  • Use a fragrance-free moisturizer (such as Eucerin® or Lubriderm®) on your breast skin. Do not put it right on your incision for 6 weeks after your surgery or until the scabbing has fully healed.
  • Do the arm and shoulder exercises your nurse tells you to do. They’ll give you a written resource with instructions. You can also find the written resources online at www.mskcc.org/pe/exercises_after_mastectomy. You may find it easier to do these stretches after you shower since your muscles will be more relaxed.
  • Wear soft, supportive bras. Do not wear underwire bras.

Daily activities

You can keep doing your normal activities after each tissue expansion. Follow these guidelines while you heal to stay safe and comfortable.

  • You can go back to work and do light housekeeping a few hours after your visit.
  • Do not lift anything heavier than 5 pounds (2.3 kilograms) with your affected arm for 6 weeks after your surgery. This includes lifting pets and children.
    • Check with your breast surgeon to see how many lymph nodes were removed during your surgery. This may change your lifting restrictions.
  • Do not have magnetic resonance imaging (MRI) done while your tissue expander is in place. This is because your tissue expander has a metal port. You can have other imaging tests, such as a bone scan, computed tomography (CT) scan, or x-rays.
  • Your tissue expander may set off airport security devices. Tell your healthcare provider if you plan to travel. They will give you a letter that says you have a medical device in your chest. Bring this letter when you travel.
  • Do not soak in a pool, bathtub, or hot tub until your healthcare provider tells you it’s safe. This is to lessen your risk of irritation or infection at your incision.
  • Your surgical sites may have less feeling than other parts of your body. Do not use a heating pad or hot or cold compress on them. This is to prevent burning or damaging your skin.

Exercising

  • Avoid strenuous exercise for about 4 to 6 weeks after surgery unless your doctor tells you it’s safe. For example, do not jog, jump, or run.
  • Avoid any type of exercise that will tighten or bulk your chest muscles. Talk with your healthcare provider about when you can start doing this type of exercise again.

Driving

  • You can drive when you have full range of motion in your shoulder on your affected side and are not taking any prescription pain medication.
  • When traveling a long distance by car, pad your seat belt if it falls right over your tissue expander. It’s important to wear your seat belt, so do not skip wearing it.

Clothing tips

Your tissue expander may be over-expanded. If you only had surgery on 1 of your breasts, your reconstructed breast may look bigger than your other breast as you near the end of the expansion process.

During the different stages of your breast reconstruction, you can pad your bra to help balance your appearance. One way to fill your bra is to use a soft breast form. A breast form is a lightweight nylon pouch. You can change the size to match your other breast by adding or taking out the cotton fluff inside. This is especially useful as your breast mound gets bigger during expansion.

You can buy a breast form from the Breast Boutique at the Evelyn H. Lauder Breast and Imaging Center (BAIC). The Breast Boutique is at 300 East 66th Street, at Second Avenue.

You can also line your bra with soft gauze. You can get the gauze from your nurse. Replace the gauze every day to make sure it’s always clean.

Some other clothing tips include wearing:

  • Loose blouses, tops, and sweaters
  • Dark knit tops under a looser open blouse, sweater, or blazer
  • Tops with diagonal stripes or asymmetrical prints
  • A neck scarf or shawl
  • Button-up, loose-fitting dresses
  • Robes

After You Finish Your Tissue Expansion

Exchange surgery

Once your tissue expander reaches the right size, the next stage of your breast reconstruction will be scheduled. This stage is the surgery to replace your tissue expander with a permanent breast implant. This is called the exchange surgery.

If you are not getting chemotherapy or radiation therapy, you can have this surgery about 6 to 8 weeks after finishing your tissue expansion. If you are getting chemotherapy or radiation therapy, you will need to wait until after you finish your treatment.

During your exchange surgery, your surgeon will use the same incisions (surgical cuts) from your mastectomy. They’ll remove your tissue expander and replace it with the permanent breast implant you choose with your plastic surgeon. Your exchange surgery will take about 1 hour for each side. If a matching procedure is done on your other breast so it matches your reconstructed breast’s size and shape, it takes more time.

You’ll be able to go home once you’ve recovered from anesthesia (medication to make you sleep during surgery). This will be the same day as your surgery, most often about 3 to 4 hours after surgery.

Nipple reconstruction and fat grafting

The last stages of reconstruction include nipple reconstruction and fat grafting, if needed. Fat grafting is when fat is taken from a part of your body and injected into your breast area. It’s done to improve your breast area’s shape. The fat is most often taken from your thighs, abdomen (belly), or breast. For more information, read Fat Injection After Breast Reconstruction.

About nipple reconstruction

Some people also want to have nipple reconstruction to recreate their nipple and areola. This procedure is most often done 2 to 4 months after the permanent implant is placed. Options for nipple and areola reconstruction are:

  • 3D nipple and areola tattoo. In this procedure, a physician assistant will recreate your nipple and areola by giving you a tattoo. The tattoo will not be raised. It will have color and shading to make it look like a natural nipple. For more information, read About Your Nipple and Areola Tattoo Procedure .
  • Nipple and areola reconstruction. In this procedure, your nipple will be reconstructed using your breast skin. Sometimes, your areola will be reconstructed using a skin graft. A skin graft is when tissue is moved from one part of your body to another part during a surgery. The place the tissue is taken from is called the donor site. The place it’s moved to is called the recipient site. Areola reconstruction can be done either in the operating room or in your surgeon’s office. For more information, read Nipple and Areola Reconstruction Using a Skin Graft.
  • A blend of these 2 procedures.

Depending on your skin and type of reconstruction, 3D tattooing may be your only option for nipple and areola reconstruction. Talk with your surgeon about which option is right for you.

Alloderm Lawsuit Breast Reconstruction

Infections and the need to remove implants are just two of the serious complications that could arise from using surgical mesh products during breast reconstruction, according to federal regulators.
On March 31st, the FDA issued a safety communication warning of the increased risk of complications when using acellular dermal matrix (ADM) products for breast reconstruction with implants. The FDA has issued a warning about a subset of surgical mesh products, saying that their use can necessitate additional surgery to remove the mesh implant.

The FDA has not cleared or approved the use of ADM for breast reconstruction. The FDA is urging doctors to inform patients that surgical mesh products are not cleared for use in breast reconstruction surgery, even though doctors are free to use the devices “off label” for whatever they see fit.

The Food and Drug Administration encourages open dialogue between physicians and patients regarding the potential benefits and drawbacks of ADM use in conjunction with implant-based breast reconstruction. The FDA wants to know if there are any risks associated with using ADM for implant-based breast reconstruction, so it’s asking for reports of any adverse events from doctors and patients.

Acellular dermal mesh (ADM) is a surgical mesh derived from human or animal skin in which the cells have been removed but the underlying framework has not. They are meant to fortify vulnerable tissue. The following brands have been clinically tested and shown to be effective in hernia repair: FlexHD, AlloMax, AlloDerm, and SurgiMend. The Food and Drug Administration (FDA) did note, however, that doctors have been increasingly using ADM off-label for implant-based breast reconstruction in recent years.

New Breast Reconstruction Techniques

The Common Method of Breast Reconstruction
Breast implants are used in the vast majority of breast reconstruction procedures. By inserting saline or silicone implants under the pectoral muscles, as in the conventional reconstruction method, the muscles are made to expand to accommodate the prostheses. Manahan states, “This method works for a good many people, but many women experience pain and decreased shoulder range of motion.” The implants “can also cause deformities of the chest wall over time.”

You may be considering a mastectomy if you have breast cancer or if you want to eliminate the possibility of developing the disease in the future. If so, you may be thinking about breast reconstruction, a customized procedure to restore your breasts after cancer treatment. Artificial implants are used in some procedures, while in others, your own tissue is used. A third group makes use of both approaches.

The process of narrowing down the options to the one that best suits your needs can be time-consuming and frustrating. Dr. Michele Manahan, an associate professor of plastic and reconstructive surgery at Johns Hopkins Medicine, says the knowledge that one has choices is paramount. It’s important to remember that there’s no such thing as a “one size fits all” approach to breast reconstruction. We have more options than ever before to help you regain your shape and confidence.

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