BioZorb® Implant Side Effects

The BioZorb® is a 3D implanted tumor bed marker created for patients with breast cancer to mark the breast cancer surgical excision site accurately. It consists of a spiral three-dimensional bioabsorbable framework embedded with six permanent titanium surgical clips. The BioZorb® offers 3-dimensional breast radiation treatment targeting and is available in various sizes from 2-5cm, including Lower Profile, and is intended to enhance results in breast-conserving surgery (BCS) when used in early breast cancer stages. Low Profile (LP) is an ideal option for smaller, flatter surgical cavities.

Dr. Gorman is one of the leading breast surgeons that has successfully used the BioZorb® implant in hundreds of Stereotactic Body Radiation Therapy (SBRT) breast cancer surgeries. She has seen firsthand how they improve outcomes with breast-conserving therapy post-surgically.

The BioZorb® implant has many benefits for patients, including excellent cosmetic outcomes, improved accuracy in radiation therapy, and minimal scarring after breast conservation therapy. Many breast cancer patients who have received breast-conserving surgery have experienced the benefits of the BioZorb® implant, though there have been a few reported side effects. This article will discuss some of the side effects reported by patients who have had the BioZorb marker implanted and how the benefits still outweigh any potential risks.

BioZorb® Reported Side Effects

  • Some patients with BioZorb® implants have reported hard, uncomfortable lumps in the area of their implants.
  • Patients have reported skin deformation and scarring of the skin around the devices.
  • Patients have reported skin reddening, irritation, and itching in the vicinity of their BioZorb® implants.
  • Patients have reported that the devices have not been absorbed in the expected time frame but instead have stayed intact for over 2.5 years.
  • Some individuals also claim that the implant is so unpleasant that they want it removed or decide to undergo partial breast reconstruction or a mastectomy to remove the entire breast.
  • Some patients report that the BioZorb® implant causes the affected breast to become noticeably bigger than the unaffected breast.

Do the benefits of the BioZorb® implant outweigh the side effects?

About 60% of the more than 200,000 American women with early-stage breast cancer had a lumpectomy with whole breast irradiation. Since it can be challenging to identify the specific region of the breast where the tumor came from, radiation is often applied to the entire breast. BioZorb® was developed to improve the accuracy of such radiation therapies, and it has done just that.

Six titanium clips on the device show radiation oncologists precisely where to point the radiation beam. Radiation is thus applied to the tissue that needs it the most. The “lumpectomy bed” will then benefit from the boost of radiation. And even though sometimes the whole breast must still undergo radiation treatment, BioZorb® guarantees that the correct location gets the optimal boost dosage. With BioZorb®, Dr. Gorman also has been able to use partial breast radiation with SBRT (BioZorb® as the target). This shortens the course of radiation to five days and has improved cosmetic outcomes.

According to a study in the World Journal of Surgery, of 110 patients using the BioZorb® implant, the marker enabled more precise targeting for radiation planning and treatments in 95.7% of the cases.

Over the course of around two years, BioZorb® is naturally absorbed by the body, but the titanium clips are left in place. As a result, during routine mammography, it is easier for your doctor to precisely analyze the former tumor spot.

Breast surgeons are utilizing an extra advantage of BioZorb® implantation. After surgery, the BioZorb® prosthetic implant aids in preserving the breast’s natural form by supporting the breast tissue. As part of your lumpectomy, the 3-D spiral design of the marker is proving to help reshape the breast, which enhances the breast’s contour and, ultimately, its aesthetic appeal.

Dr. Gorman and BioZorb®

BioZorb® provides breast cancer surgeons with another cutting-edge method to enhance therapeutic and cosmetic results and improve overall patient outcomes. Dr. Gorman believes that for many patients, the benefits of the BioZorb® device outweigh any potential side effects. She continues to perform surgeries with the BioZorb® implant to help more women heal and recover.

If you have questions about the BioZorb® device or breast cancer treatment, please call our office to schedule an appointment. At your consultation, Dr. Gorman will be happy to personally answer all of your questions. Texas Breast Center is committed to providing its patients with a personal, individualized, and targeted approach to breast surgery and breast cancer treatment.


History of Breast Cancer

March is Women’s History Month. The history of women and the history of breast cancer go hand in hand. But how far back does the history of breast cancer go? How long have we known about it, and how long have we been able to treat it? This article will discuss treatments and diagnoses of breast cancer since antiquity.

Who first discovered breast cancer?

When did breast cancer start?

Breast cancer, and cancer as a whole, has likely been around as long as humanity has. Evidence of prostate cancer has been found on skeletons of both a Russian king (approximately 2,700 years old) and an Egyptian mummy (about 2,200 years old). But the earliest record we have of breast cancer can be found on the Edwin Smith Surgical Papyrus, an Egyptian papyrus dating back to 3000-2500 BC. While the papyrus does not offer much in the way of treatment options, it does give a way to identify an incurable disease as “cool to touch, bulging and spread all over the breast.”

Ancient Greece, around 460 BC, gave us the term carcinoma (karkinoma). Carcinoma is a cancer that starts in skin or organ tissue cells rather than in structures like blood vessels or bones. However, breast cancer treatment was still relatively unsuccessful as it was believed that disease was caused by imbalances of the four humours, phlegm, yellow bile, black bile, and blood. To treat illnesses, one had to remove or increase the humours within the body. Galen, a well-known Greek physician from around 168 BC, claimed that breast cancer was caused by too much black bile and began to treat the condition with surgery to remove the tumor, though he let the incisions bleed to continue removing excess bile.

While the surgery that Galen performed spread throughout Greece, the increase in religious philosophies and medical approaches prevented the practice from going much further. Early Christianity believed surgery to be more barbaric than their faith healing preference, a tradition that persisted through much of the world between 476 and 1500 AD. However, between the 10th and 15th centuries, Abu Al-Qasim Al-Zahrawl and Ibn Sina, a pair of Islamic physicians, revived the Greek practices, including surgery, and wrote many medical texts. Their ideas and practices spread throughout Europe.

The 16th, 17th, and 18th centuries, known more commonly as the Renaissance period, saw a growth in surgical practice. Where once ‘surgeon’ was simply a title tagged onto the end of ‘barber’, and a procedure could be performed after a haircut, surgeons now had their own trade. John Hunter, a Scottish surgeon, proposes the first idea of breast cancer in stages. While not as clearly defined as those we have today, there were some stages where surgery was necessary, while others were not. This was also a time of no anesthesia, so these early lumpectomies and mastectomies had to be performed quickly and accurately.

As the 19th century rolled around, significant improvements were made to the safety of surgery. With the introduction of hygiene to medical practices (albeit slowly), disinfection and surgical garments became more common. Anesthesia was also developed, helping prevent patient shock and give the doctors more time to perform the breast cancer surgery. William Halsted, an American surgeon, developed the radical mastectomy procedure in 1894. This procedure removes the entire tumor in a single piece together with the breast, the axillary lymph nodes, lymphatic vessels, and pectoral muscles. This was the first time breast cancer was considered treatable and even curable. Two years later, Thomas Beatson, a British surgeon, announces that oophorectomies–operations to remove one or both ovaries– can reduce tumors in advance breast cancer.

Modern Breast Cancer Treatments

The 20th century brought vast change to breast cancer treatment. Tumors were shrunk using radiation. Chemotherapy was introduced in the 1940s, and Robert Egan introduced mammography as a breast cancer detection option in 1962. The first modern autologous breast reconstruction was performed in 1979, allowing for more natural feeling breasts. More medications, procedures, and treatments for breast cancer have been researched and implemented, as well as potential causes and risk factors. The BRCA1 and BRCA2 genes–commonly known as the breast cancer gene– were discovered in 1995. A few years later, new breast cancer subtypes–HER2 positive, triple-negative, progesterone receptor-positive, and estrogen receptor-positive–were classified in 2000.

Even today, new research is still being performed to improve upon the surgeries, treatments, and post-op for breast cancer patients to have the best possible results. Dr. Gorman was involved in a study using the Biozorb implantable marker that helps target radiation therapy as well as post-operation imaging. She also contributes to the study on Accelerated Partial Breast Irradiation, or APBI, a method that shortens the amount of time the patient needs to spend getting radiation therapy and uses a higher dose of radiation in a more targeted beam–assisted by the Biozorb marker. She also uses oncoplastic techniques which help with postoperative cosmesis.

Breast Cancer Treatment Today

With today’s understanding of the disease, treatment is far more effective than it has been in the past. One primary reason for this is the improved breast cancer screening guidelines and understanding of breast cancer risk factors such as family history or having the so-called ‘breast cancer genes’. Knowledge of these risk factors can help set up specific screening procedures for those with a higher risk of breast cancer while still having a standard screening arrangement for those with lower risk. Getting a regular mammogram and breast self exam are easy steps to keep an eye out for early potential signs and symptoms. The sooner breast cancer is caught, the easier it is to treat.

Once a breast cancer diagnosis is reached, a treatment plan is agreed upon; no patient’s treatment plan and recovery are exactly alike. Treatment plans can–but do not necessarily–include breast surgery, radiation therapy, chemotherapy, hormone therapy, targeted medical therapy, as well as cosmetic surgery to aid in the patient’s self-image after an oncological procedure. Each of these treatment options has benefits and downsides and side effects and is more useful in some situations than others. The different surgical approaches can be applied depending on the tumor’s size and how far the breast cancer cells have spread. There are options to save more of the breast tissue and chest muscles if the breast cancer is caught early enough.

Combination treatments–surgery accompanied by radiation therapy or chemotherapy alongside medical therapy, for example–can help by approaching the breast cancer from different angles, ensuring thorough results with no cancer cells left behind and decreasing recurrence. With a combined effort from a full oncological team, the survival and recovery rates have increased exponentially since the days of the Edwin Smith Surgical Papyrus.

Dr. Gorman and her team at the Texas Breast Center work together to treat breast cancer from all angles. Dr. Gorman focuses on treating from the surgical side and works closely with medical and radiation oncologists to form a personalized treatment plan best suited to each patient. She also looks to the future of treatment by keeping aware of current and ongoing breast cancer research to best treat her patients. If you have questions or are ready to find your next steps in treatment, reach out to the Texas Breast Center. The team is prepared to help.


Exploring New Findings in Breast Cancer Research

The week of December 10, Dr. Valerie Gorman attended the annual San Antonio Breast Cancer Symposium to give a poster presentation for her research in 5-day SBRT radiation. This symposium is an opportunity for those involved in breast cancer research to share what they have learned.

The SABCS’ stated objective states that the conference “is designed to provide state-of-the-art information on the experimental biology, etiology, prevention, diagnosis, and therapy of breast cancer and premalignant breast disease, to an international audience of academic and private physicians and researchers.” Research is brought from all of these categories to be shared and help other practitioners improve their own research or treatments.

Dr. Gorman praises this conference for the multidisciplinary spread of study. As her breast cancer team is interdisciplinary, she can gather information that will interest every member of her team. She noted that there were presentations this year on “molecular studies on circulating tumor cells, more targeted therapies, and many other topics. Together with our oncology colleagues and team members, we’re able to use these to treat our patients in a collaborative, multidisciplinary fashion.”

For example, while Dr. Gorman does not specialize or perform chemotherapy treatment, she took note of several tailored researched studies into chemotherapy. There is new research being done on HER2 positive cancer, or breast cancer that tests positive for human epidermal growth factor receptor 2. HER2 protein excess is found in approximately 20% of breast cancers, caused by a gene mutation in the cancer cells. There is also chemotherapy targeting metastatic breast cancer, which is cancer that has spread beyond the point of origin–in this case, the breast and lymph nodes nearby. Patients with these cancers tend to have a lot of, and many kinds of chemo throughout their treatment. These new studies are helping us to learn how to “study the tumor and retailor the chemotherapy to the individual patient and their needs.”

The presentation that Dr. Gorman and her team were most interested in, however, came from the University of Florence in Italy. They presented on the ten-year results of breast cancer patients who had been treated with Accelerated Partial Breast Irradiation (APBI), a treatment Dr. Gorman has been using and perfecting for many years.

The use of radiation therapy on breast cancer is a common occurrence. This treatment directs high energy rays directly at the cancerous area to kill any cancerous cells left over after surgery. Traditionally, radiation therapy is implemented over 30 days. This regimen includes visits every weekday for six weeks and can potentially lead to burns on the surrounding tissue as well as changes in the patient’s appearance. However, APBI shortens the number of days needed for the treatment. Some protocols of APBI give radiotherapy twice a day for five days, while others–including Dr. Gorman’s practice–only give it once a day for five days. While the treatment itself takes little time in office, doctors know transport and waiting room time can take up valuable time from the patient’s personal and work life. By minimizing how many office visits are required, these doctors are giving their patients more of their life back.
The presentation that the University of Florence gave reveals new results from patients ten years after their surgeries and radiotherapy treatments. The results found that survival rates at the ten-year mark for those who received APBI–as with the five-year mark–matched the survival rate of those who received longer treatments. However, APBI has better cosmetic results and less burn damage.

Dr. Gorman is pleased to know that this treatment helps her patients, not only by treating their breast cancer but also by lessening the impact that breast cancer has on their personal life. With few in-office treatments, there is less time away from the office or the family. The APBI also produces more favorable cosmetic results, which can help with a healthier mindset as you approach healing.
Dr. Gorman and her team offer APBI when necessary to provide the breast results and the least interference in her patients’ lives. They also provides necessary breast cancer surgery to best help a given case. As the Chief of Surgery and Medical Director of Surgical Service of Baylor Scott and White Medical Center in Waxahachie, Dr. Valerie Gorman, MD, FACS is ready to answer your questions and design a personalized cancer treatment plan for you.


The BioZorb Marker Could Help Post-Surgical Breast Cancer Results and Clinical Imaging

What is BioZorb?

The BioZorb marker is a medical device meant to be implanted in the surgical site. Thanks to its open structure, it can be stitched into place by breast surgeons to avoid movement and allow the surrounding tissue to grow around the device after the procedure. The marker has six titanium clips that are used for future clinical imaging.

What is BioZorb Made of?

The structure itself is made of a material that is bioabsorbable, or able to be absorbed by the body. Therefore, as the tissue grows and reforms, the BioZorb can be absorbed, leaving behind only the titanium clips as tissue markers for imaging if necessary. This process takes approximately a year.

How Does BioZorb Help?

Using a BioZorb implant in breast cancer treatment can be helpful surgically, cosmetically, and with radiation treatment. Surgically, the implant–or the titanium clips if the implant has already been absorbed–can provide a perfect reference point for any future imaging for where the previous breast surgery and radiation procedures took place.

It can also assist with the structure of healing, which lends itself to improved breast cosmesis. Often with tumor removal, the breast can appear concave where the tissue grew in to fill the void the tumor left. However, BioZorb offers structure for the surrounding tissue to grow around to prevent any potential divots. This can sometimes help with oncoplastic surgery or post-lumpectomy cosmetic surgery. As for radiation therapy, the implant can provide a target for the beam to minimize the radiation damaging any surrounding tissue unnecessarily.

What are some facts about BioZorb?

Your doctor is placing an implant into your breast during this surgery. The implant is firm, but not painful and can usually be felt in the breast for 12 to 18 months, even once the surgical scars have healed. It will eventually be absorbed by the body.

When should BioZorb be used?

It is not uncommon for a patient to react strongly when they hear a diagnosis of breast cancer. They may want to avoid any risk and go straight for the total mastectomy, removing the full breast and therefore the cancer.

However, with a breast cancer team working with you on your treatment, there is more room for a personalized approach. The cancer can be treated with surgery, radiation, or a combination of the two, and when it is caught at an early stage, a total mastectomy is not needed. A lumpectomy can remove a tumor while leaving most of the breast intact.

It is in these cases that BioZorb is useful. When a patient is able to receive breast-conserving surgery, the cancerous tissue is removed by the breast surgeon, and then the skin is closed. From there, radiation may be administered by a radiation oncologist to reduce the risk of recurrence without damaging the surrounding tissue. This can be difficult without something in the breast to mark where the surgery took place. Sometimes, the empty space of the surgical site where the tumor was will fill with a liquid, forming a seroma, and this can be an indication of where to radiate.

However, if BioZorb is placed in the breast during surgery, the metal marker clips work like a road sign pointing the way for the radiologist to follow. Even after the body absorbs the coils, the clips remain in case they are needed again for imaging purposes.

Dr. Gorman and BioZorb

Dr. Valerie Gorman uses BioZorb in applicable cases to help her patients recover with less pain, less cosmetic adjustment, and more accurate imaging. But she did not take this step lightly. Before jumping all in with BioZorb, she was involved with a study testing accelerated partial breast irradiation (APBI) using her preferred intensity modulated radiation therapy (IMRT). The IMRT was directed in each of the 57 cases by a BioZorb device to keep the radiation localized.

They found that, in the follow-up visits, the cosmetic results were excellent on all accounts. Only one patient experienced pain in the area, at it was easily treated. Patients were pleased with the results.

Dr. Gorman has completed over 100 BioZorb procedures, and she and her team know the benefits it can bring. She will answer any questions you have. She always wants you to be comfortable and knowledgeable about your treatment, which is why she has done her own research into BioZorb. She wants you to receive the best treatment and best results in the long term.

Read the article: Biozorb Potential Side Effects


Streamlined Treatment for Breast Cancer Reduces Your Treatment Time

Partial breast radiation offered by Dr. Valerie Gorman, Breast Surgeon at Texas Breast Center, may reduce some treatment time by two-thirds.New radiation option cuts time by two-thirds

By Valerie Gorman, MD, FACS, Breast Surgeon at Texas Surgical Specialists

If you receive a diagnosis of breast cancer, it can be overwhelming. You’ll have to sort through a lot of information quickly and make decisions about what treatment is best for you.

For many of my patients with early stage breast cancer, lumpectomy – removing the tumor surgically – is the recommended treatment option. But you have to have radiation after a lumpectomy. That’s part of the package.

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