BioZorb® Implant Side Effects

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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.

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

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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

Valerie Gorman, MD Presents With Hologic at 20th Annual Meeting of the American Society of Breast Surgeons

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Breast surgeon Dr. Valerie Gorman presented at the Annual Meeting of the American Society of Breast Surgeons. Hologic, Inc. (Nasdaq: HOLX) will showcase its growing breast surgery franchise, which includes products such as the new Trident® HD specimen radiography system, LOCalizer ™ wire-free guidance system and the BioZorb ® marker, in Booth #103 at the 20th Annual Meeting of The American Society of Breast Surgeons (ASBS) in Dallas from April 30 to May 5.

The pioneer behind the Genius™ 3D Mammography™ exam, Hologic has recently expanded its product portfolio significantly through insight-driven innovation and strategic acquisitions to address the entire clinical continuum of breast cancer diagnosis and care. From digital specimen radiography and stereotactic breast biopsy systems to breast biopsy markers and surgical guidance systems – Hologic’s comprehensive suite of products is designed to meet the unmet and changing needs of radiologists, pathologists and breast surgeons.

“ASBS marks an exciting milestone this year as we debut our newly expanded portfolio of breast-conserving surgery solutions,” said Pete Valenti, Hologic’s Division President, Breast and Skeletal Health Solutions. “We look forward to building upon our relationships with this community of leading breast surgeons and showcasing our growing suite of products designed to improve cancer detection, patient satisfaction and comfort, and facility workflow.”

Hologic Products

A sampling of the products on display in the Hologic booth includes:

The Trident®HD specimen radiography system, a next-generation solution that delivers enhanced image quality, improved workflow, and instant sample verification during breast-conserving surgeries and stereotactic breast biopsies. 1 The system, which recently received FDA clearance in the U.S. and a CE Mark in Europe, uses amorphous selenium direct capture imaging – the same detector technology used in Hologic’s 3Dimensions™ mammography system – to generate crisp, clear, high-resolution images. The system also features a bigger detector that allows for complete imaging of larger breast surgical specimens, along with a wide range of surgical and biopsy samples. 2

The LOCalizer™wire-free guidance system, which is designed to enable precision and ease of use for breast surgery guidance. The LOCalizer tag is designed to replace traditional wire-guided methods, helping provide increased comfort and convenience for patients and their healthcare teams. Additionally, the Tag is designed to be implanted into the breast any time prior to the surgery, providing increased flexibility for patients and providers. A recent study has shown that the LOCalizer tag may be able to reduce positive margin rates with lumpectomy due to the unique feature of reading distance from the tag. 3

The BioZorb®3D bioabsorbable marker, an implantable three-dimensional marker that potentially enables a more targeted radiation therapy and helps clinicians overcome challenges in breast-conserving surgery or lumpectomy. When used to mark the surgical site, BioZorb has been shown to yield good to excellent cosmetic outcomes for at least two years post-surgery and result in minimal scarring on mammography after breast-conserving surgery. 4,5 Additionally, the marker has been shown to improve accuracy in setup and boost targeting as reported by 96 percent of radiation oncologists. 6

The TruNode®wireless gamma probe, a sterile, single-use device for common, radio-guided surgical procedures that senses hotspots using an innovative detector and heuristic audio feedback technology. The TruNode probe is designed to perform less invasively and may reduce infection risk from reprocessing due to its sterile, single-use performance.

Dr. Gorman’s Presentation on 5-day Radiation Therapy

Hologic will also host a breakfast symposium, BioZorb® and a New Way to 5-day radiation, featuring Cary Kaufman, MD, FACS and Valerie Gorman, MD, FACS on Saturday, May 4 from 6:30 – 7:45 am. Additional hands-on workshops hosted by Hologic will cover topics such as stereotactic breast biopsy, oncoplastic skills, and portable breast ultrasound.

The Genius ™ 3D Mammography ™ exam (also known as the Genius ™ exam) is only available on a Hologic® 3D Mammography™ system. It consists of a 2D and 3D ™ image set, where the 2D image can be either an acquired 2D image or a 2D image generated from the 3D ™ image set. There are more than 6,000 Hologic 3D Mammography ™ systems in use in the U.S. alone, so women have convenient access to the Genius exam. To learn more about the Genius exam, visit http://www.Genius3DNearMe.com.

About Hologic, Inc.

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Hologic, 3D, 3D Mammography, 3Dimensions, BioZorb, Genius, The Science of Sure, Trident and TruNode are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries. Hologic is an exclusive distributor and licensee of the LOCalizer product and trademark, which is manufactured by Health Beacons.

Forward-Looking Statements

This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.

This information is not intended as a product solicitation or promotion where such activities are prohibited. For specific information on what products are available for sale in a particular country, please contact a local Hologic sales representative or write to [email protected].

SOURCE: Hologic, Inc., used by permission.

1 Wilson A. Trident 2.0 QUAL Qualitative Findings. Explore and identify the ideal breast biopsy verification system from the OR. Kadence International. July 2016.

2 Compared to original Trident system

3 N = 50 patient, single arm pilot study. DiNome M et al. Microchipping the breast: an effective new technology for localizing non-palpable breast lesions for surgery. Poster presentation, Society of Surgical Oncology annual meeting, Mar 27-30, 2019.

4 Kaufman, et al. Oncoplastic Surgery with the 3-D Tissue Implant Maintains Post-Lumpectomy Breast Contour. Poster presented at the American Society of Breast Surgeons 18th Annual Meeting, May 2-5, 2018.

5 Kaufman CS, et al. Registry Study of 337 Bio-Absorbable 3-D Implants Marking Lumpectomy Cavity Benefit Cosmesis While Targeting Radiation. Poster presented at the Society of Surgical Oncology Annual Cancer Conference March 15-17, 2017.

6 Harms S, et al. Mammographic imaging after partial breast reconstruction: Impact of a bioabsorbable breast implant. J Clin Oncol 33, 2015 (suppl 28S; abstr 111)

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