From the department

Plastic, reconstructive and aesthetic surgery

From explantation to breast reconstruction

How aesthetic surgery changes not only changes the body, but also life

In an interview with Hellersen Insight, Dr. Petra Scheffer, Chief of Ästhetik Hellersen, tells the impressive story of a patient who found her way to Sportklinik Hellersen after the implant manufacturer issued a recall and her breast implants were subsequently removed. After the implants were removed, the patient suffered from severely deformed and asymmetrical breasts that were marked by deep scarring.

Video: Interview with Dr. Petra Scheffer

What is BIA-ALCL?

  • BIA-ALCL: Breast implant-associated anaplastic large cell lymphoma

  • Rare type of cancer associated with breast implants

  • Typically occurs 8–10 years after implantation

  • Main symptom: fluid accumulation around the implant

  • Higher risk with heavily textured implants

Can you explain what type of breast implants were originally used in the patient and why they were recalled?

Dr. Petra Scheffer: The patient received textured implants in 2013. At that time, the choice was mainly between smooth and textured variants. Smooth implants were less commonly used in Europe and the US because they were more likely to cause capsular contracture and could slip more easily. Textured implants were considered a better choice because their rough surface promoted stability in the tissue.

Over time, it became apparent that certain heavily textured implants were associated with late complications. Fluid formed around the implants and, in rare cases, cancer cells were found in it. As of 2018, there were 516 documented cases worldwide of BIA-ALCL, or breast implant-associated anaplastic large cell lymphoma. At that time, there were about seven cases in Germany. This cancer affects lymphocytes, a type of white blood cell, and can occur not only in the fluid around the implants, but also in lymph nodes, bones, lungs, or the liver.

The recall related to highly textured implants, particularly those from one manufacturer, whose stock was withdrawn in Europe at the end of 2018 and worldwide in 2019. The recall only affected the texture of the implant surface and had no impact on implants that had already been used or their contents. Since then, the industry has switched to microtextured surfaces to meet the highest standards.

Findings after 2x external surgeries

6 weeks after 3rd surgery

6 months after 4th surgery

How can such complications be recognized and how are affected patients treated?

Dr. Petra Scheffer: Typical symptoms of a possible complication after implantation include breast swelling, redness, or a feeling of pressure. It is important to rule out infections first, as these occur much more frequently. However, degeneration, i.e., uncontrolled cell change in which cells lose their normal structure and function and become malignant tumors, is extremely rare—the probability is about 1 in 1 million. If there is still suspicion, a standardized procedure is followed: First, an ultrasound or MRI examination is performed. If fluid is present, it is punctured using ultrasound and analyzed comprehensively around 100 ml of fluid is removed to obtain sufficient material for laboratory analysis. The fluid is examined for cancer markers using immunohistochemistry and for possible bacterial infections.

In the present case, the patient complained of pain in her left breast in 2021. After thorough diagnostics, another hospital decided to remove the implants. Such decisions are made on an individual basis and based on the respective findings. Fortunately, the examinations confirmed that the patient did not have malignant tumor disease.

“This approach gave the patient the opportunity to decide calmly what was best for her in the long term.”

Dr. Petra Scheffer
Chief Physician for Plastic, Reconstructive,
and Aesthetic Surgery

How did you assess the patient's severely scarred and asymmetrical breasts after the implant removal? What options did you suggest to her?

Dr. Petra Scheffer: First, I examined the patient, felt the scars, and assessed the movement of the breast, for example when she raised her arms. I noticed that the breast was very deformed and asymmetrical. There was almost no volume left, especially in the lower part of the right breast. The breast had completely lost its round shape due to the pronounced scars.

I then explained to the patient step by step how I would proceed, and we discussed it together in front of a mirror so that she could understand it better. My suggestion was to first remove the scars and restore the breast to a round shape. Although it would be possible to insert an implant immediately, this carries a high risk of complications.

Removing scars creates larger wound areas that can bleed more heavily. There is also a risk that a heavily scarred and hardened capsule will form around the implant shell. I therefore recommended that she wait at least six months after scar removal and shape correction before considering implants. During this time, the breast will settle into its natural teardrop shape as the swelling subsides.

I also offered her the option of foregoing implants altogether if she was satisfied with the natural shape of her breasts after healing. The symmetry could be adjusted, for example, with autologous fat on the right side without further surgery on the left. However, implants can achieve a larger overall volume. This approach gives the patient the opportunity to decide at her leisure what is best for her in the long term.

Implant Registry Germany (IRD)

  • Mandatory introduction since July 2024
  • Documentation of all implants used
  • Improved traceability and patient care
  • Reporting obligation for healthcare facilities
  • Goal: Quality assurance and long-term monitoring of implants
  • Legal basis: Implant Register Act
  • Further information:
    • BfArM (Federal Institute for Drugs and Medical Devices)
    • DGPRÄC (German Society for Plastic, Reconstructive, and Aesthetic Surgery)

Why were different implant sizes used during the last operation?

Dr. Petra Scheffer: The lower right breast pole was significantly smaller than the left, which is why I chose a larger implant of 425 ml on the right side to balance the shape and volume. On the left side, I used 350 ml to achieve a symmetrical and aesthetically pleasing breast shape. We opted for anatomical teardrop-shaped implants, as these are particularly well suited to compensating for defects in the lower breast area, whereas round implants would tend to emphasize the upper area. Anatomical implants offer a natural breast shape and, when placed correctly, can produce excellent results.

“We take such complaints very seriously and investigate them thoroughly.”

Dr. Petra Scheffer
Chief of Plastic, Reconstructive
and Aesthetic Surgery

Photo: Rawpixel | freepik.com

What is the aftercare for the patient and how do you ensure that no further complications arise?

Dr. Petra Scheffer: After discharge, I usually see all patients, regardless of whether they were treated on an outpatient or inpatient basis, after two days and then again after two weeks.

We use absorbable material in the crease under the breast; only the knots at the ends are removed after two to three weeks. This is followed by check-ups after six weeks and six months.

I always advise my patients to inform their gynecologist that they have implants and to provide them with the implant card and a surgical report. As part of routine examinations, an ultrasound of the breast should be performed annually.

In addition, it is important that patients regularly examine their breasts themselves, as in breast cancer screening. If unusual symptoms such as pressure, swelling, redness, or pain occur, patients should contact us immediately. We take such complaints very seriously and investigate them thoroughly.

What are your long-term expectations regarding the durability and safety of the new implants?

Dr. Petra Scheffer: In general, breast implants are not designed to last a lifetime, as there is always a certain amount of material fatigue. However, we now use modern implants that have a multi-layered shell and contain cohesive gel instead of liquid silicone—similar to “jelly.” This means that the gel cannot leak out if the implant ruptures. While it used to be recommended that implants be replaced after about 10 years, there are no longer any firm recommendations.

The main problem is not the material of the implant, but the body itself. The body always forms a thin shell around the foreign body, known as a capsule. However, if this capsule hardens or scars, it can contract so much that it causes pain and changes the shape of the implant. In such cases, the implant must be removed and possibly replaced.

To minimize the risk of capsule hardening, we place the implant under the muscle and choose a fine texture for the implant surface. Studies show that the incidence of capsule formation ranges between 0.6 and 17 percent. In this patient, the risk is slightly higher due to multiple surgeries and existing scars. We therefore proceeded with particular caution. We first reconstructed the breast and allowed it to heal for about nine months before inserting implants. This sequential approach helps to significantly reduce the risk of capsule formation.

“During follow-up checks, the patient described how happy she now is in retrospect.”

Dr. Petra Scheffer
Chief of Plastic, Reconstructive
and Aesthetic Surgery

How did you support the patient emotionally after the numerous procedures and the associated challenges?

Dr. Petra Scheffer: When I first met her, the patient was rather reserved and often turned to her husband, who accompanied her. It is understandable that she was very unsettled by her previous experience and therefore wanted to seek a second opinion. My detailed explanations of the advantages and disadvantages of the various surgical options and the resulting understanding of the patient and her partner of how the complex healing system works gave her security and confidence. She had enough time to decide whether she really wanted to have implants again. The patient also received valuable support from her husband, who accompanied her to all important appointments and procedures. Later, it was clear that she was able to attend the follow-up appointments independently and with a positive attitude.

Her relief at not having a malignant disease was palpable, and the open communication helped her to make an informed decision, including the option of not having implants. Overall, I consider her to be a stable person who maintained a positive attitude despite the challenges. During the last follow-up appointments, the patient described how happy she was each time.

Surgeries performed

First breast surgery:

  • 2013: External breast augmentation
  • Implants: 360 ml per side
  • Recall of macrotextured implant stocks due to occurrence of BIA-ALCL

Removal of implants:

  • March 2022: Breast implants were removed
  • Examination revealed no malignant tumor disease

First corrective surgery:

  • June 23, 2023: Surgery performed by Dr. Petra Scheffer
  • Scars were removed and the breast was lifted to restore its shape

Second corrective surgery:

  • March 25, 2024: Breast augmentation performed by Dr. Petra Scheffer
  • New implants: Anatomical, teardrop-shaped implants inserted under the muscle
  • Sizes: 350 ml left side, 425 ml right side to correct asymmetry